Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Products tagged as [GENERIC] have had a generic equivalent approved for at least one strength of the product.
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5006528 DS* DP* [Extended 5 years] Carbostyril derivatives Claim Types: Compound; Composition | OCT 20,2014 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | AUG 28,2006 | I-401: Longer-term efficacy of aripiprazole in the treatment of schizophrenia |
| Exclusivity Code: I - New Indication | SEP 29,2007 | I-437: Treatment of acute manic and mixed episodes associated with bipolar disorder |
| Exclusivity Code: I - New Indication | MAR 01,2008 | I-488: Maintenance therapy in bipolar I disorder |
| Exclusivity Code: NCE - New chemical entity | NOV 15,2007 |
ABILIFY (SOLUTION) ARIPIPRAZOLE
NDA Applicant: OTSUKA NDA No.: 021713 Prod. No.: 001 RX (1MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5006528 DS* DP* [Extended 5 years] Carbostyril derivatives Claim Types: Compound; Composition | OCT 20,2014 | |
| Pat. No. 6977257 DS* DP* Aripiprazole oral solution Claim Types: Formulation | APR 24,2022 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | AUG 28,2006 | I-401: Longer-term efficacy of aripiprazole in the treatment of schizophrenia |
| Exclusivity Code: I - New Indication | SEP 29,2007 | I-437: Treatment of acute manic and mixed episodes associated with bipolar disorder |
| Exclusivity Code: I - New Indication | MAR 01,2008 | I-488: Maintenance therapy in bipolar I disorder |
| Exclusivity Code: NCE - New chemical entity | NOV 15,2007 |
ABRAXANE (FOR SUSPENSION) PACLITAXEL
NDA Applicant: ABRAXIS BIOSCIENCE NDA No.: 021660 Prod. No.: 001 RX (100MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5439686 DP* Methods for in vivo delivery of substantially water insoluble pharmacologically active agents and compositions useful therefor Claim Types: Composition; Method of use | FEB 22,2013 | |
| Pat. No. 5498421 DP* Composition useful for in vivo delivery of biologics and methods employing same Claim Types: Composition; Method of use | MAR 12,2013 | U-634: Method for delivery of a biologic (including antineoplastic agents) by administering to a patient an effective amount of a biologic as a solid or liquid with a polymeric biocompatible material |
| Pat. No. 6096331 DP* Methods and compositions useful for administration of chemotherapeutic agents Claim Types: Method of administration; Method of use | FEB 22,2013 | U-633: Method for treatment of tumors by administering paclitaxel at a dose in the range of about 30mg/meter square to about 100mg/meter square in a pharmaceutically acceptable formulation that does not contain cremophor |
| Pat. No. 6506405 DP* Methods and formulations of cremophor-free taxanes Claim Types: Composition; Formulation; Method of use; Drug in a container | FEB 22,2013 | U-633: Method for treatment of tumors by administering paclitaxel at a dose in the range of about 30mg/meter square to about 100mg/meter square in a pharmaceutically acceptable formulation that does not contain cremophor |
| Pat. No. 6537579 Compositions and methods for administration of pharmacologically active compounds Claim Types: Method of use | FEB 22,2013 | U-632: Method of treatment of cancer by administering particles of paclitaxel that have a protein coating |
| Pat. No. 6749868 DP* Protein stabilized pharmacologically active agents, methods for the preparation thereof and methods for the use thereof Claim Types: Composition | FEB 22,2013 | |
| Pat. No. 6753006 DP* Paclitaxel-containing formulations Claim Types: Drug in a container | FEB 22,2013 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | JAN 07,2008 |
ABREVA (CREAM) DOCOSANOL
NDA Applicant: GLAXOSMITHKLINE NDA No.: 020941 Prod. No.: 001 OTC (10%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4874794 [Extended 5 years] Inflammatory disease treatment Claim Types: Method of use | APR 28,2014 |
ACCOLATE (TABLET) ZAFIRLUKAST
Drug Classes: ANTIASTHMATICS/BRONCODILATORS
NDA Applicant: ASTRAZENECA NDA No.: 020547 Prod. No.: 001 RX (20MG); 003 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4859692 [Extended 1496 days* (4.1 years)] Heterocyclic amide derivatives and pharmaceutical use Claim Types: Compound; Composition; Method of use | SEP 26,2010 | |
| Pat. No. 5294636 Crystalline form of indole derivative and pharmaceutical method thereof Claim Types: New polymorph, salt or hydrate; Composition; Method of use | DEC 11,2011 | |
| Pat. No. 5319097 Pharmaceutical agents Claim Types: New polymorph, salt or hydrate; Composition; Process | DEC 11,2011 | |
| Pat. No. 5482963 Pharmaceutical agents useful as leukotriene antagonists Claim Types: Composition; Method of use | JAN 09,2013 | |
| Pat. No. 5583152 Method for treating vasospastic cardiovascular diseases heterocyclic amide derivatives Claim Types: Method of use | SEP 26,2010 | |
| Pat. No. 5612367 Method of enhancing bioavailability of pharmaceutical agents Claim Types: Process | MAR 18,2014 | U-189: Enhancement of the bioavailability of the drug substance |
| Pat. No. 6143775 Process for preparing pharmaceutical composition containing a heterocyclic amide Claim Types: New polymorph, salt or hydrate | DEC 11,2011 |
ACCUNEB (SOLUTION) ALBUTEROL SULFATE [GENERIC AN]
Drug Classes: ANTIASTHMATICS/BRONCODILATORS
NDA Applicant: DEY NDA No.: 020949 Prod. No.: 001 RX (EQ 0.042% BASE); 002 RX (EQ 0.021% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6702997 Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma Claim Types: Method of use | DEC 28,2021 | U-558: Indicated for the relief of bronchospasm in patients 2-12 years of age with asthma (reversible obstructive airway disease) |
ACCUPRIL (TABLET) QUINAPRIL HYDROCHLORIDE [GENERIC AB]
Drug Classes: ACE INHIBITORS; ANTIVIRALS
NDA Applicant: PFIZER PHARMS NDA No.: 019885 Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 003 RX (EQ 20MG BASE); 004 RX (EQ 40MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4743450 Stabilized compositions Claim Types: Formulation; Process | AUG 24,2007 *PED | |
| Pat. No. 5684016 Method of treating cardiac insufficiency Claim Types: Method of use | MAY 04,2015 *PED | U-210: Method of treating congestive heart failure |
ACCURETIC (TABLET) HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANTIHYPERTENSIVES; DIURETICS; ACE INHIBITORS
NDA Applicant: PFIZER PHARMS NDA No.: 020125 Prod. No.: 001 RX (12.5MG;EQ 10MG BASE); 002 RX (12.5MG;EQ 20MG BASE); 003 RX (25MG;EQ 20MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4743450 Stabilized compositions Claim Types: Formulation; Process | AUG 24,2007 *PED |
ACEON (TABLET) PERINDOPRIL ERBUMINE
Drug Classes: ACE INHIBITORS
NDA Applicant: SOLVAY PHARMS NDA No.: 020184 Prod. No.: 001 RX (2MG); 002 RX (4MG); 003 RX (8MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4508729 [Extended 1601 days (4.4 years)] Substituted iminodiacids, their preparation and pharmaceutical compositions containing them Claim Types: Compound; Composition; Method of use | AUG 21,2006 | |
| Pat. No. 5162362 DS* DP* Octahydroindole-2-carboxylic acids Claim Types: Compound; Composition; Method of use | NOV 10,2009 | U-531: Treatment of patients with essential hypertension. May be used alone or given with other classes of antihypertensives, especially thiazide derivatives |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | AUG 23,2008 | I-468: Use in patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or non-fatal myocardial infection |
ACETADOTE (INJECTABLE) ACETYLCYSTEINE
NDA Applicant: CUMBERLAND PHARMS NDA No.: 021539 Prod. No.: 001 RX (6GM/30ML (200MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code ODE: Orphan Drug | JAN 23,2011 | For the intravenous treatment of moderate to severe acetaminophen overdose |
ACIPHEX (TABLET, DELAYED RELEASE) RABEPRAZOLE SODIUM
Drug Classes: DISORDERS, ACID/PEPTIC; GASTROINTESTINAL, MISCELLANEOUS
NDA Applicant: EISAI MEDCL RES NDA No.: 020973 Prod. No.: 002 RX (20MG) NDA No.: 020973 Prod. No.: 001 DISC (10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5035899 Peroral preparation of acid-unstable compound Claim Types: Formulation | APR 04,2009 | U-385: Treatment of peptic ulcers |
| Pat. No. 5045552 [Extended 1708 days (4.7 years)] Pyridine derivatives having anti-ulcerative activity Claim Types: Compound; Composition; Method of use | MAY 08,2013 | U-385: Treatment of peptic ulcers |
ACTINEX (CREAM) MASOPROCOL
NDA Applicant: UNIV AZ CANCER CTR NDA No.: 019940 Prod. No.: 001 DISC (10%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4695590 [Extended 122 days* (0.3 years)] Method for retarding aging Claim Types: Method of use; Composition | APR 17,2008 | |
| Pat. No. 5008294 Methods of treating tumors with compositions of catecholic butanes Claim Types: Method of use | APR 15,2008 | U-68: Treatment of actinic keratosis |
ACTIQ (SUGAR-FREE) (TROCHE/LOZENGE) FENTANYL CITRATE
Drug Classes: ANALGESICS-NARCOTIC
NDA Applicant: CEPHALON NDA No.: 020747 Prod. No.: 001 RX (EQ 0.2MG BASE); 002 RX (EQ 0.4MG BASE); 003 RX (EQ 0.6MG BASE); 004 RX (EQ 0.8MG BASE); 005 RX (EQ 1.2MG BASE); 006 RX (EQ 1.6MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4863737 Compositions and methods of manufacture of compressed powder medicaments Claim Types: Device; Process | SEP 05,2006 |
ACTIVELLA (TABLET) ESTRADIOL; NORETHINDRONE ACETATE
Drug Classes: ESTROGENS/PROGESTINS
NDA Applicant: NOVO NORDISK INC NDA No.: 020907 Prod. No.: 001 RX (1MG;0.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE36247 Method of hormonal treatment for menopausal or post-menopausal disorders involving continuous administration of progestogens and estrogens Claim Types: Method of use; Formulation | MAY 02,2006 |
ACTONEL (TABLET) RISEDRONATE SODIUM
Drug Classes: CALCIUM METABOLISM
NDA Applicant: PROCTER AND GAMBLE NDA No.: 020835 Prod. No.: 001 RX (30MG); 002 RX (5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5583122 Pharmaceutical compositions containing geminal diphosphonates Claim Types: Compound; Composition; Method of use | DEC 10,2013 | U-222: Method of treating Paget's disease using ACTONEL |
| Pat. No. 6096342 Dosage forms of risedronate Claim Types: Formulation | NOV 22,2011 | |
| Pat. No. 6165513 Film-coated tablet for improved upper gastrointestinal tract safety Claim Types: Formulation | JUN 10,2018 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | JAN 24,2009 | M-52: Information added to the clinical pharmacology/clinical studies section regarding the use of risedronate administered once a week in the prevention of osteoporosis in postmenopausal women |
ACTONEL (TABLET) RISEDRONATE SODIUM
Drug Classes: CALCIUM METABOLISM
NDA Applicant: PROCTER AND GAMBLE NDA No.: 020835 Prod. No.: 003 RX (35MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5583122 DS* DP* Pharmaceutical compositions containing geminal diphosphonates Claim Types: Compound; Composition; Method of use | DEC 10,2013 | U-222: Method of treating Paget's disease using ACTONEL |
| Pat. No. 5583122 DS* DP* Pharmaceutical compositions containing geminal diphosphonates Claim Types: Compound; Composition; Method of use | DEC 10,2013 | U-756: Addition of once-weekly dosing for the treatment to increase bone mass in men with osteoporosis |
| Pat. No. 5994329 Method for inhibiting bone resorption Claim Types: Method of use; Kit | JUL 17,2018 | U-353: Prevention and treatment of osteoporosis |
| Pat. No. 6015801 Method for inhibiting bone resorption Claim Types: Method of use | JUL 17,2018 | U-353: Prevention and treatment of osteoporosis |
| Pat. No. 6096342 DP* Dosage forms of risedronate Claim Types: Formulation | NOV 22,2011 | |
| Pat. No. 6165513 DP* Film-coated tablet for improved upper gastrointestinal tract safety Claim Types: Formulation | JUN 10,2018 | |
| Pat. No. 6432932 Method for inhibiting bone resorption Claim Types: Method of use | JUL 17,2018 | U-595: 35 mg orally once a week for prevention of osteoporosis in postmenopausal women; 35 mg orally once a week for treatment of osteoporosis in postmenopausal women |
| Pat. No. 6465443 DP* Method for inhibiting bone resorption Claim Types: Composition; Kit | AUG 14,2018 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | AUG 11,2009 | I-309: Use of ACTONEL 35mg once a week to increase bone mass in men with osteoporosis |
| Exclusivity Code: M - Miscellaneous | JAN 24,2009 | M-52: Information added to the clinical pharmacology/clinical studies section regarding the use of risedronate administered once a week in the prevention of osteoporosis in postmenopausal women |
ACTONEL WITH CALCIUM (COPACKAGED) (TABLET, TABLET) CALCIUM CARBONATE; RISEDRONATE SODIUM
NDA Applicant: PROCTER AND GAMBLE NDA No.: 021823 Prod. No.: 001 RX (EQ 500MG BASE,N/A;N/A,35MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5583122 DS* DP* Pharmaceutical compositions containing geminal diphosphonates Claim Types: Compound; Composition; Method of use | DEC 10,2013 | U-353: Prevention and treatment of osteoporosis |
| Pat. No. 5994329 Method for inhibiting bone resorption Claim Types: Method of use; Kit | JUL 17,2018 | U-353: Prevention and treatment of osteoporosis |
| Pat. No. 6015801 Method for inhibiting bone resorption Claim Types: Method of use | JUL 17,2018 | U-353: Prevention and treatment of osteoporosis |
| Pat. No. 6096342 DP* Dosage forms of risedronate Claim Types: Formulation | NOV 21,2011 | |
| Pat. No. 6165513 DP* Film-coated tablet for improved upper gastrointestinal tract safety Claim Types: Formulation | JUN 10,2018 | |
| Pat. No. 6432932 Method for inhibiting bone resorption Claim Types: Method of use | JUL 17,2018 | U-595: 35 mg orally once a week for prevention of osteoporosis in postmenopausal women; 35 mg orally once a week for treatment of osteoporosis in postmenopausal women |
| Pat. No. 6465443 DP* Method for inhibiting bone resorption Claim Types: Composition; Kit | AUG 14,2018 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | JAN 24,2009 | M-52: Information added to the clinical pharmacology/clinical studies section regarding the use of risedronate administered once a week in the prevention of osteoporosis in postmenopausal women |
ACTOPLUS MET (TABLET) METFORMIN; PIOGLITAZONE HYDROCHLORIDE
NDA Applicant: TAKEDA GLOBAL NDA No.: 021842 Prod. No.: 001 RX (500MG;EQ 15MG BASE); 002 RX (850MG;EQ 15MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4687777 DS* [Extended 5 years] Thiazolidinedione derivatives, useful as antidiabetic agents Claim Types: Compound; Composition | JAN 17,2011 | |
| Pat. No. 5965584 DP* Pharmaceutical composition Claim Types: Composition; Method of use | JUN 19,2016 | U-679: Adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes who are already treated with a pioglitazone and metformin |
| Pat. No. 6166042 Pharmaceutical composition Claim Types: Method of use | JUN 19,2016 | U-679: Adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes who are already treated with a pioglitazone and metformin |
| Pat. No. 6166043 Pharmaceutical composition Claim Types: Method of use | JUN 19,2016 | U-679: Adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes who are already treated with a pioglitazone and metformin |
| Pat. No. 6172090 Pharmaceutical composition Claim Types: Method of use | JUN 19,2016 | U-679: Adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes who are already treated with a pioglitazone and metformin |
ACTOS (TABLET) PIOGLITAZONE HYDROCHLORIDE
Drug Classes: BLOOD GLUCOSE REGULATORS
NDA Applicant: TAKEDA PHARMS NA NDA No.: 021073 Prod. No.: 001 RX (EQ 15MG BASE); 002 RX (EQ 30MG BASE); 003 RX (EQ 45MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4687777 [Extended 5 years] Thiazolidinedione derivatives, useful as antidiabetic agents Claim Types: Compound; Composition | JAN 17,2011 | |
| Pat. No. 5965584 Pharmaceutical composition Claim Types: Composition; Method of use | JUN 19,2016 | U-417: Combination use of AD-4833 with a biguanide |
| Pat. No. 6150383 Pharmaceutical composition Claim Types: Method of use | JUN 19,2016 | U-418: A method of treating lipid metabolism disorders by administering a chemical compound having a particular formula (which includes pioglitazone) in combination with an insulin secretion enhancer |
| Pat. No. 6150384 Pharmaceutical composition Claim Types: Method of use | JUN 19,2016 | U-419: A method of treating lipid metabolism disorders by administering an insulin sensitivity enhancer (including pioglitazone) in combination with a biguanide |
| Pat. No. 6166042 Pharmaceutical composition Claim Types: Method of use | JUN 19,2016 | U-414: A method of treating glycometabolism disorders by administering an insulin sensitivity enhancer (including pioglitazone) in combination with a biguanide |
| Pat. No. 6166043 Pharmaceutical composition Claim Types: Method of use | JUN 19,2016 | U-415: A method for reducing the amount of active components administered to a diabetic patient by administering an insulin sensitivity enhancer (including pioglitazone) in combination with a biguanide as said active components |
| Pat. No. 6172090 Pharmaceutical composition Claim Types: Method of use | JUN 19,2016 | U-416: A method for reducing side effects of active components administered to a diabetic patient by administering an insulin sensitivity enhancer (including pioglitazone) in combination with a biguanide as said active components |
| Pat. No. 6211205 Pharmaceutical composition Claim Types: Method of improving a treatment | JUN 19,2016 | U-410: Method of reducing amount of respective active components administered to a diabetic patient by administering a chemical compound having a particular formula (including pioglitazone) in combination with an insulin secretion enhancer |
| Pat. No. 6271243 Pharmaceutical composition Claim Types: Method of improving a treatment | JUN 19,2016 | U-411: Method of reducing the side effects of active components administered to a diabetic patient by administering a chemical compound having a particular formula (which includes pioglitazone) in combination with an insulin preparation |
| Pat. No. 6303640 Pharmaceutical composition Claim Types: Method of improving a treatment | AUG 09,2016 | U-425: Method of reducing side effects of active components admin to a diabetic by admin a chemical compound having formula (incl pioglitazone) in combination with an insulin secretion enhancer |
| Pat. No. 6329404 Pharmaceutical composition Claim Types: Composition; Method of use | JUN 19,2016 | U-430: Method of treating a diabetic by administering an insulin sensitizer in combination with an insulin secretion enhancer, and a drug product comprising an insulin sensitizer and an insulin secretion enhancer |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | NOV 26,2006 | M-35: Additional information regarding clinical studies done with ACTOS in combination with metformin, a sulfonylurea, or insulin added to clinical pharmacology |
ACULAR (SOLUTION/DROPS) KETOROLAC TROMETHAMINE
Drug Classes: OCULAR ANTI-INFECTIVE/ANTI-INFLAMMATORY; OPHTHALMICS, MISCELLANEOUS
NDA Applicant: ALLERGAN NDA No.: 019700 Prod. No.: 001 RX (0.5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5110493 Ophthalmic NSAID formulations containing a quaternary ammonium preservative and a nonionic surfactant Claim Types: Formulation; Excipient | NOV 05,2009 *PED | U-75: Relief of ocular itching due to seasonal allergic conjunctivitis |
ACULAR LS (SOLUTION/DROPS) KETOROLAC TROMETHAMINE
Drug Classes: ANALGESICS, GENERAL
NDA Applicant: ALLERGAN NDA No.: 021528 Prod. No.: 001 RX (0.4%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5110493 Ophthalmic NSAID formulations containing a quaternary ammonium preservative and a nonionic surfactant Claim Types: Formulation; Excipient | NOV 05,2009 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | MAY 30,2006 |
ACUTECT (INJECTABLE) TECHNETIUM TC-99M APCITIDE
Drug Classes: DIAGNOSTICS, RADIOPAQUE & NONRADIOACTIVE
NDA Applicant: CIS BIO INTL SA NDA No.: 020887 Prod. No.: 001 DISC (N/A)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5443815 Technetium-99m labeled peptides for imaging Claim Types: Composition; Kit; Process | AUG 22,2012 | |
| Pat. No. 5508020 Technetium-99M labeled peptides for imaging Claim Types: Composition | APR 16,2013 | |
| Pat. No. 5645815 Radiolabled compounds for thrombus imaging Claim Types: Intermediate; Kit; Diagnostic or surgical method | JUL 08,2014 |
ACZONE (GEL) DAPSONE
NDA Applicant: QLT USA NDA No.: 021794 Prod. No.: 001 DISC (5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5863560 DP* Compositions and methods for topical application of therapeutic agents Claim Types: Formulation | SEP 11,2016 | |
| Pat. No. 6620435 DP* Compositions for topical application of therapeutic agents Claim Types: Formulation | SEP 11,2016 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NDF - New dosage form | JUL 07,2008 |
ADALAT CC (TABLET, EXTENDED RELEASE) NIFEDIPINE [GENERIC AB1]
Drug Classes: CALCIUM CHANNEL BLOCKERS; ANTIANGINALS; ANTIHYPERTENSIVES
NDA Applicant: BAYER PHARMS NDA No.: 020198 Prod. No.: 001 RX (30MG); 002 RX (60MG); 003 RX (90MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4892741 Press coated DHP tablets Claim Types: Formulation; Process | JUN 08,2008 | |
| Pat. No. 5264446 Solid medicament formulations containing nifedipine, and processes for their preparation Claim Types: Formulation; Method of use | NOV 23,2010 |
ADDERALL 10; ADDERALL 20; ADDERALL 5; ADDERALL 30; ADDERALL 7.5; ADDERALL 12.5; ADDERALL 15 (TABLET) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE [GENERIC AB]
Drug Classes: ANOREXIANTS/CNS STIMULANTS
NDA Applicant: SHIRE NDA No.: 011522 Prod. No.: 007 RX (2.5MG;2.5MG;2.5MG;2.5MG); 008 RX (5MG;5MG;5MG;5MG); 009 RX (1.25MG;1.25MG;1.25MG;1.25MG); 010 RX (7.5MG;7.5MG;7.5MG;7.5MG); 011 RX (1.875MG;1.875MG;1.875MG;1.875MG); 012 RX (3.125MG;3.125MG;3.125MG;3.125MG); 013 RX (3.75MG;3.75MG;3.75MG;3.75MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6384020 Rapid immediate release oral dosage form Claim Types: Formulation | JAN 06,2021 *PED |
ADDERALL XR 10; ADDERALL XR 20; ADDERALL XR 30; ADDERALL XR 25; ADDERALL XR 5; ADDERALL XR 15 (CAPSULE, EXTENDED RELEASE) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Drug Classes: ANOREXIANTS/CNS STIMULANTS
NDA Applicant: SHIRE NDA No.: 021303 Prod. No.: 001 RX (2.5MG;2.5MG;2.5MG;2.5MG); 002 RX (5MG;5MG;5MG;5MG); 003 RX (7.5MG;7.5MG;7.5MG;7.5MG); 004 RX (6.25MG;6.25MG;6.25MG;6.25MG); 005 RX (1.25MG;1.25MG;1.25MG;1.25MG); 006 RX (3.75MG;3.75MG;3.75MG;3.75MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6322819 Oral pulsed dose drug delivery system Claim Types: Formulation | APR 21,2019 *PED | |
| Pat. No. 6605300 Oral pulsed dose drug delivery system Claim Types: Formulation | APR 21,2019 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | AUG 11,2007 | |
| Exclusivity Code: NPP - New patient population | Jan 21,2009 PED |
ADENOSCAN (INJECTABLE) ADENOSINE [Has competitive generic]
Drug Classes: ANTIARRHYTHMICS
NDA Applicant: ASTELLAS NDA No.: 020059 Prod. No.: 001 RX (3MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5070877 [Extended 159 days* (0.4 years)] Novel method of myocardial imaging Claim Types: Diagnostic or surgical method | MAY 18,2009 | U-116: Method of myocardial imaging |
| Pat. No. 5731296 Selective vasodilation by continuous adenosine infusion Claim Types: Method of use | MAR 24,2015 | U-221: Selective vasodilation by continuous adenosine infusion |
ADVAIR DISKUS 100/50 (POWDER) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: ANTIASTHMATICS/BRONCODILATORS
NDA Applicant: GLAXOSMITHKLINE NDA No.: 021077 Prod. No.: 001 RX (0.1MG/INH;EQ 0.05MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4992474 Phenethanolamine derivatives Claim Types: Compound; Composition; Method of use | AUG 12,2008 *PED | U-211: Use in patients with reversible airway obstruction |
| Pat. No. 5126375 Phenethanolamine derivatives Claim Types: Compound; Composition | AUG 12,2008 *PED | |
| Pat. No. 5225445 Phenethanolamine derivatives having .beta..sub.2 -adrenoreceptor selective stimulant action Claim Types: Method of use | AUG 12,2008 *PED | U-211: Use in patients with reversible airway obstruction |
| Pat. No. 5270305 Medicaments Claim Types: Composition; Method of use | SEP 07,2010 | U-387: Treatment of patients with respiratory disorders |
| Pat. No. 6536427 DP* Inhalation device Claim Types: Device | SEP 01,2011 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | APR 21,2007 | M-33: Information for use of ADVAIR DISKUS 100/50 in children 4 to 11 years of age with asthma |
ADVAIR DISKUS 250/50 (POWDER) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: ANTIASTHMATICS/BRONCODILATORS
NDA Applicant: GLAXOSMITHKLINE NDA No.: 021077 Prod. No.: 002 RX (0.25MG/INH;EQ 0.05MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4992474 Phenethanolamine derivatives Claim Types: Compound; Composition; Method of use | AUG 12,2008 *PED | U-211: Use in patients with reversible airway obstruction |
| Pat. No. 5126375 Phenethanolamine derivatives Claim Types: Compound; Composition | AUG 12,2008 *PED | |
| Pat. No. 5225445 Phenethanolamine derivatives having .beta..sub.2 -adrenoreceptor selective stimulant action Claim Types: Method of use | AUG 12,2008 *PED | U-211: Use in patients with reversible airway obstruction |
| Pat. No. 5270305 Medicaments Claim Types: Composition; Method of use | SEP 07,2010 | U-387: Treatment of patients with respiratory disorders |
| Pat. No. 6536427 DP* Inhalation device Claim Types: Device | SEP 01,2011 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | NOV 17,2006 | I-410: Use of ADVAIR DISKUS 250/50 for chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis |
ADVAIR DISKUS 500/50 (POWDER) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: ANTIASTHMATICS/BRONCODILATORS
NDA Applicant: GLAXOSMITHKLINE NDA No.: 021077 Prod. No.: 003 RX (0.5MG/INH;EQ 0.05MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4992474 Phenethanolamine derivatives Claim Types: Compound; Composition; Method of use | AUG 12,2008 *PED | U-211: Use in patients with reversible airway obstruction |
| Pat. No. 5126375 Phenethanolamine derivatives Claim Types: Compound; Composition | AUG 12,2008 *PED | |
| Pat. No. 5225445 Phenethanolamine derivatives having .beta..sub.2 -adrenoreceptor selective stimulant action Claim Types: Method of use | AUG 12,2008 *PED | U-211: Use in patients with reversible airway obstruction |
| Pat. No. 5270305 Medicaments Claim Types: Composition; Method of use | SEP 07,2010 | U-387: Treatment of patients with respiratory disorders |
| Pat. No. 6536427 DP* Inhalation device Claim Types: Device | SEP 01,2011 *PED |
ADVAIR HFA (AEROSOL, METERED) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
NDA Applicant: GLAXOSMITHKLINE NDA No.: 021254 Prod. No.: 001 RX (0.045MG/INH;EQ 0.021MG BASE/INH); 002 RX (0.115MG/INH;EQ 0.021MG BASE/INH); 003 RX (0.23MG/INH;EQ 0.021MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4992474 DS* DP* Phenethanolamine derivatives Claim Types: Compound; Composition; Method of use | AUG 12,2008 *PED | U-738: Indicated for the long-term, twice-daily maintenance treatment of asthma in patients 12 years of age or older |
| Pat. No. 5126375 DS* DP* Phenethanolamine derivatives Claim Types: Compound; Composition | AUG 12,2008 *PED | |
| Pat. No. 5225445 Phenethanolamine derivatives having .beta..sub.2 -adrenoreceptor selective stimulant action Claim Types: Method of use | AUG 12,2008 *PED | U-738: Indicated for the long-term, twice-daily maintenance treatment of asthma in patients 12 years of age or older |
| Pat. No. 5270305 Medicaments Claim Types: Composition; Method of use | SEP 07,2010 | U-738: Indicated for the long-term, twice-daily maintenance treatment of asthma in patients 12 years of age or older |
| Pat. No. 5658549 DP* Aerosol formulations containing propellant 134a and fluticasone propionate Claim Types: Formulation; Method of use | AUG 19,2014 | U-738: Indicated for the long-term, twice-daily maintenance treatment of asthma in patients 12 years of age or older |
| Pat. No. 5674472 DP* Canisters containing aerosol formulations containing P134a and fluticasone propionate Claim Types: Device | OCT 07,2014 | |
| Pat. No. 6143277 DP* Metered dose inhaler for salmeterol Claim Types: Drug in a container; Device; Method of administration | APR 14,2015 | U-738: Indicated for the long-term, twice-daily maintenance treatment of asthma in patients 12 years of age or older |
| Pat. No. 6251368 DP* Pharmaceutical aerosol formulation containing a particulate medicament, a propellant and substantially free of a surfactant Claim Types: Formulation | DEC 04,2012 | |
| Pat. No. 6253762 DP* Metered dose inhaler for fluticasone propionate Claim Types: Device; Method of use | APR 14,2015 | U-738: Indicated for the long-term, twice-daily maintenance treatment of asthma in patients 12 years of age or older |
| Pat. No. 6315173 DP* Valve for aerosol container Claim Types: Device | DEC 23,2017 | |
| Pat. No. 6510969 DP* Valve for aerosol container Claim Types: Device | DEC 23,2017 | |
| Pat. No. 6524555 DP* Metered dose inhaler for salmeterol Claim Types: Drug in a container | APR 14,2015 | |
| Pat. No. 6546928 DP* Metered dose inhaler for fluticasone propionate Claim Types: Device | APR 14,2015 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | JUN 08,2009 |
ADVICOR (TABLET, EXTENDED RELEASE) LOVASTATIN; NIACIN
Drug Classes: HYPERLIPIDEMIA
NDA Applicant: KOS LIFE NDA No.: 021249 Prod. No.: 001 RX (20MG;500MG); 002 RX (20MG;750MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6080428 Nicotinic acid compositions for treating hyperlipidemia and related methods therefor Claim Types: Method of use | MAY 27,2017 | U-447: Method of treating hyperlipidemia with nicotinic acid by dosing once per day in the evening or at night |
| Pat. No. 6129930 Methods and sustained release nicotinic acid compositions for treating hyperlipidemia at night Claim Types: Method of administration; Composition | SEP 20,2013 | U-448: Method of treating hyperlipidemia with nicotinic acid without causing treatment-limiting elevations in uric acid or glucose levels or causing liver damage, by dosing once per day in the evening or at night |
| Pat. No. 6406715 Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique urinary metabolite profiles Claim Types: Formulation | OCT 31,2017 | U-450: Intermediate rel nicotinic acid formulations having unique urinary metab profiles resulting from absorption profiles of nicotinic acid from the intermediate nicotinic acid formulations, suitable for tx hyperlipidemia following qd dosing |
| Pat. No. 6676967 Methods for reducing flushing in individuals being treated with nicotinic acid for hyperlipidemia Claim Types: Method of improving a treatment | SEP 20,2013 | U-548: A Method of reducing flush in an individual being treated for a lipidemic disorder and effectively treating the lipidemic disorder |
| Pat. No. 6746691 Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique biopharmaceutical characteristics Claim Types: Formulation | SEP 20,2013 | U-586: An intermediate release nicotinic acid formulation suitable for oral administration once-a-day as a single dose for treating hyperlipidemia without causing drug-induced hepatotoxicity or elevations in uric acid or glucose or both |
| Pat. No. 6818229 DP* Intermediate release nicotinic acid compositions for treating hyperlipidemia Claim Types: Composition; Formulation | FEB 15,2014 | |
| Pat. No. 7011848 Hydrophobic component free sustained release nicotinic acid compositions for treating hyperlipidemia and related methods therefor Claim Types: Method of use | SEP 20,2013 | U-712: A method of using a nicotinic acid formulation to reduce elevated TC, lDL-C and TG levels, and raise HDL-c levels in patients with hyperlipidemia |
ADVICOR (TABLET, EXTENDED RELEASE) LOVASTATIN; NIACIN
Drug Classes: HYPERLIPIDEMIA
NDA Applicant: KOS LIFE NDA No.: 021249 Prod. No.: 003 RX (20MG;1GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6080428 Nicotinic acid compositions for treating hyperlipidemia and related methods therefor Claim Types: Method of use | MAY 27,2017 | U-447: Method of treating hyperlipidemia with nicotinic acid by dosing once per day in the evening or at night |
| Pat. No. 6129930 Methods and sustained release nicotinic acid compositions for treating hyperlipidemia at night Claim Types: Method of administration; Composition | SEP 20,2013 | U-448: Method of treating hyperlipidemia with nicotinic acid without causing treatment-limiting elevations in uric acid or glucose levels or causing liver damage, by dosing once per day in the evening or at night |
| Pat. No. 6406715 Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique urinary metabolite profiles Claim Types: Formulation | OCT 31,2017 | U-450: Intermediate rel nicotinic acid formulations having unique urinary metab profiles resulting from absorption profiles of nicotinic acid from the intermediate nicotinic acid formulations, suitable for tx hyperlipidemia following qd dosing |
| Pat. No. 6676967 Methods for reducing flushing in individuals being treated with nicotinic acid for hyperlipidemia Claim Types: Method of improving a treatment | SEP 20,2013 | U-548: A Method of reducing flush in an individual being treated for a lipidemic disorder and effectively treating the lipidemic disorder |
| Pat. No. 6746691 Intermediate release nicotinic acid compositions for treating hyperlipidemia having unique biopharmaceutical characteristics Claim Types: Formulation | SEP 20,2013 | U-586: An intermediate release nicotinic acid formulation suitable for oral administration once-a-day as a single dose for treating hyperlipidemia without causing drug-induced hepatotoxicity or elevations in uric acid or glucose or both |
| Pat. No. 7011848 Hydrophobic component free sustained release nicotinic acid compositions for treating hyperlipidemia and related methods therefor Claim Types: Method of use | SEP 20,2013 | U-712: A method of using a nicotinic acid formulation to reduce elevated TC, lDL-C and TG levels, and raise HDL-c levels in patients with hyperlipidemia |
ADVIL ALLERGY SINUS, CHILDREN'S (SUSPENSION) CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
NDA Applicant: WYETH CONS NDA No.: 021587 Prod. No.: 001 OTC (1MG/5ML;100MG/5ML;15MG/5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NP - New product | FEB 24,2007 |
ADVIL COLD AND SINUS (CAPSULE) IBUPROFEN POTASSIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
NDA Applicant: WYETH CONS NDA No.: 021374 Prod. No.: 001 OTC (200MG;30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5071643 Solvent system enhancing the solubility of pharmaceuticals for encapsulation Claim Types: Formulation | JUN 10,2009 *PED | |
| Pat. No. 5360615 Solvent system enhancing the solubility of pharmaceuticals for encapsulation Claim Types: Formulation | JUN 10,2009 *PED |
ADVIL PM (CAPSULE) DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN POTASSIUM
NDA Applicant: WYETH CONS NDA No.: 021393 Prod. No.: 001 OTC (25MG;200MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NC - New combination | DEC 21,2008 |
ADVIL PM (TABLET) DIPHENHYDRAMINE CITRATE; IBUPROFEN
NDA Applicant: WYETH CONS NDA No.: 021394 Prod. No.: 001 OTC (38MG;200MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NC - New combination | DEC 21,2008 |
ADVIL, CHILDREN'S (SUSPENSION) IBUPROFEN [Has competitive generic]
NDA Applicant: WYETH CONS NDA No.: 019833 Prod. No.: 002 RX (100MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4788220 Pediatric ibuprofen compositions Claim Types: Formulation | MAY 29,2006 *PED |
ADVIL, CHILDREN'S (SUSPENSION) IBUPROFEN [GENERIC OTC]
NDA Applicant: WYETH CONS NDA No.: 020589 Prod. No.: 001 OTC (100MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4788220 Pediatric ibuprofen compositions Claim Types: Formulation | JAN 08,2008 *PED |
AEROBID (AEROSOL, METERED) FLUNISOLIDE
NDA Applicant: ROCHE PALO NDA No.: 018340 Prod. No.: 001 RX (0.25MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4933168 Stable, crystalline flunisolide Claim Types: New polymorph, salt or hydrate; Formulation; Method of use | JUN 12,2007 |
AEROSPAN HFA (AEROSOL, METERED) FLUNISOLIDE
NDA Applicant: FOREST LABS NDA No.: 021247 Prod. No.: 001 RX (EQ 78UGM BASE/INH)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NP - New product | JAN 27,2009 |
AGENERASE (CAPSULE) AMPRENAVIR
Drug Classes: ANTIVIRALS
NDA Applicant: GLAXOSMITHKLINE NDA No.: 021007 Prod. No.: 001 RX (50MG) NDA No.: 021007 Prod. No.: 002 DISC (150MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5585397 Sulfonamide inhibitors of aspartyl protease Claim Types: Compound; Composition | DEC 17,2013 | |
| Pat. No. 5646180 Treatment of the CNS effects of HIV Claim Types: Method of use | JUL 08,2014 | U-257: Treatment of HIV infection |
| Pat. No. 5723490 THF-containing sulfonamide inhibitors of aspartyl protease Claim Types: Composition; Method of use | MAR 03,2015 | U-257: Treatment of HIV infection |
| Pat. No. 6730679 DP* Pharmaceutical formulations Claim Types: Formulation | NOV 11,2017 |
AGENERASE (SOLUTION) AMPRENAVIR
Drug Classes: ANTIVIRALS
NDA Applicant: GLAXOSMITHKLINE NDA No.: 021039 Prod. No.: 001 RX (15MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5585397 Sulfonamide inhibitors of aspartyl protease Claim Types: Compound; Composition | DEC 17,2013 | |
| Pat. No. 5646180 Treatment of the CNS effects of HIV Claim Types: Method of use | JUL 08,2014 | U-257: Treatment of HIV infection |
| Pat. No. 5723490 THF-containing sulfonamide inhibitors of aspartyl protease Claim Types: Composition; Method of use | MAR 03,2015 | U-257: Treatment of HIV infection |
AGGRASTAT (INJECTABLE) TIROFIBAN HYDROCHLORIDE
Drug Classes: ANTICOAGULANTS/THROMBOLYTICS
NDA Applicant: MEDICURE NDA No.: 020912 Prod. No.: 001 RX (EQ 0.25MG BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5292756 [Extended 433 days* (1.2 years)] Novel sulfonamide fibrinogen receptor antagonists Claim Types: Compound; Method of use | MAY 14,2012 | U-230: Prevention of acute cardiac ischemic events |
| Pat. No. 5658929 Sulfonamide fibrinogen receptor antagonists Claim Types: Compound | SEP 27,2010 | |
| Pat. No. 5733919 Compositions for inhibiting platelet aggregation Claim Types: Formulation | OCT 23,2016 | |
| Pat. No. 5880136 Sulfonamide fibrinogen receptor antagonists Claim Types: Method of use | SEP 27,2010 | U-254: Use of AGGRASTAT in combination with heparin |
| Pat. No. 5965581 Compositions for inhibiting platelet aggregation Claim Types: Formulation; Product-by-process; Method of use | OCT 23,2016 | |
| Pat. No. 5972967 Compositions for inhibiting platelet aggregation Claim Types: Formulation; Method of use; Product-by-process | OCT 23,2016 | |
| Pat. No. 5978698 Angioplasty procedure using nonionic contrast media Claim Types: Method of use | OCT 08,2017 | |
| Pat. No. 6136794 Platelet aggregation inhibition using low molecular weight heparin in combination with a GP IIb/IIIa antagonist Claim Types: Method of use | JAN 29,2019 |
AGGRASTAT (INJECTABLE) TIROFIBAN HYDROCHLORIDE
Drug Classes: ANTICOAGULANTS/THROMBOLYTICS
NDA Applicant: MEDICURE NDA No.: 020913 Prod. No.: 001 RX (EQ 0.05MG BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5292756 [Extended 433 days* (1.2 years)] Novel sulfonamide fibrinogen receptor antagonists Claim Types: Compound; Method of use | MAY 14,2012 | U-230: Prevention of acute cardiac ischemic events |
| Pat. No. 5658929 Sulfonamide fibrinogen receptor antagonists Claim Types: Compound | SEP 27,2010 | |
| Pat. No. 5733919 Compositions for inhibiting platelet aggregation Claim Types: Formulation | OCT 23,2016 | |
| Pat. No. 5880136 Sulfonamide fibrinogen receptor antagonists Claim Types: Method of use | SEP 27,2010 | U-254: Use of AGGRASTAT in combination with heparin |
| Pat. No. 5965581 Compositions for inhibiting platelet aggregation Claim Types: Formulation; Product-by-process; Method of use | OCT 23,2016 | |
| Pat. No. 5972967 Compositions for inhibiting platelet aggregation Claim Types: Formulation; Method of use; Product-by-process | OCT 23,2016 | |
| Pat. No. 5978698 Angioplasty procedure using nonionic contrast media Claim Types: Method of use | OCT 08,2017 | |
| Pat. No. 6136794 Platelet aggregation inhibition using low molecular weight heparin in combination with a GP IIb/IIIa antagonist Claim Types: Method of use | JAN 29,2019 |
AGGRENOX (CAPSULE, EXTENDED RELEASE) ASPIRIN; DIPYRIDAMOLE
Drug Classes: ANTICOAGULANTS/THROMBOLYTICS
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 020884 Prod. No.: 001 RX (25MG;200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6015577 Pharmaceutical compositions containing dipyridamole or mopidamol and acetylsalicylic acid or the physiologically acceptable salts thereof, processes for preparing them and their use in treating clot formation Claim Types: Formulation; Method of use | JAN 18,2017 | U-302: To reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis |
AGRYLIN (CAPSULE) ANAGRELIDE HYDROCHLORIDE [GENERIC AB]
NDA Applicant: SHIRE NDA No.: 020333 Prod. No.: 001 RX (EQ 0.5MG BASE); 002 RX (EQ 1MG BASE)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: M - Miscellaneous | Jun 10,2008 PED | M-39: For labeling changes based on results of the SPD422-202 clinical study report (CSR) submitted in response to the written request |
ALAMAST (SOLUTION/DROPS) PEMIROLAST POTASSIUM
Drug Classes: OCULAR ANTI-INFECTIVE/ANTI-INFLAMMATORY; OPHTHALMICS, MISCELLANEOUS
NDA Applicant: SANTEN NDA No.: 021079 Prod. No.: 001 RX (0.1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5034230 Anti-allergic ophthalmics Claim Types: Formulation; Method of use | JUN 23,2009 *PED | U-184: Treating allergic eye diseases in humans |
ALDARA (CREAM) IMIQUIMOD
Drug Classes: DERMATOLOGICS
NDA Applicant: 3M NDA No.: 020723 Prod. No.: 001 RX (5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4689338 [Extended 5 years] 1H-Imidazo[4,5-c]quinolin-4-amines and antiviral use Claim Types: Compound; Composition; Method of use | AUG 25,2009 | U-172: Treatment of genital warts |
| Pat. No. 5238944 Topical formulations and transdermal delivery systems containing 1-isobutyl-1H-imidazo[4,5-c]quinolin-4-amine Claim Types: Formulation; Method of administration | AUG 24,2010 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | MAR 02,2007 | I-420: Topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults |
| Exclusivity Code: I - New Indication | JUL 14,2007 | I-433: Treatment of biopsy-confirmed, primary superficial basal cell carcinoma in immunocompetent adults, with a maximum tumor diameter of 2.0cm, located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet) |
ALIMTA (INJECTABLE) PEMETREXED DISODIUM
Drug Classes: ANTIMETABOLITES
NDA Applicant: LILLY NDA No.: 021462 Prod. No.: 001 RX (EQ 500MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5217974 Method for treating gar-transformylase tumors in mammals and reducing mammalian toxicity Claim Types: Method of use; Method of improving a treatment | MAR 29,2011 | U-551: Method for reducing toxicity of ALIMTA treated patients by administering folic acid |
| Pat. No. 5344932 DS* DP* N-(pyrrolo(2,3-d)pyrimidin-3-ylacyl)-glutamic acid derivatives Claim Types: Compound | SEP 06,2011 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | FEB 04,2009 | |
| Exclusivity Code ODE: Orphan Drug | FEB 04,2011 | Treatment of malignant pleural mesothelioma |
ALINIA (TABLET) NITAZOXANIDE
Drug Classes: ANTIPROTOZOALS; ANTHELMINTICS
NDA Applicant: ROMARK NDA No.: 021497 Prod. No.: 001 RX (500MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5387598 DP* Composition and galenic formulation suitable for combatting affections of the lower abdomen Claim Types: Formulation; Method of use | FEB 07,2012 | U-524: Method of treating diarrhea |
| Pat. No. 5578621 DP* Benzamide derivatives Claim Types: Composition; Method of use; Method of improving a treatment | NOV 26,2013 | U-525: Method of treating parasitic infections |
| Pat. No. 5968961 DP* Pharmaceutical compositions of tizoxanide and nitazoxanide Claim Types: Formulation | MAY 07,2017 | |
| Pat. No. 6020353 DS* DP* 2-(hydroxy)-N-(5-nitro-2-thiazolyl) benzamide Claim Types: Compound; Composition | SEP 18,2014 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | JUN 16,2008 | I-460: Treatment of diarrhea caused by cryptosporidium parvum in non-HIV infected patients 12 years of age and older |
| Exclusivity Code: NCE - New chemical entity | NOV 22,2007 | |
| Exclusivity Code: NDF - New dosage form | JUL 21,2007 | |
| Exclusivity Code ODE: Orphan Drug | NOV 22,2009 | Treatment of cryptosporidiosis. |
| Exclusivity Code ODE: Orphan Drug | NOV 22,2009 | Treatment of intestinal giardiasis. |
ALINIA (FOR SUSPENSION) NITAZOXANIDE
Drug Classes: ANTIPROTOZOALS; ANTHELMINTICS
NDA Applicant: ROMARK NDA No.: 021498 Prod. No.: 001 RX (100MG/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5387598 Composition and galenic formulation suitable for combatting affections of the lower abdomen Claim Types: Formulation; Method of use | FEB 07,2012 | U-524: Method of treating diarrhea |
| Pat. No. 5578621 Benzamide derivatives Claim Types: Composition; Method of use; Method of improving a treatment | SEP 08,2014 | U-525: Method of treating parasitic infections |
| Pat. No. 5965590 Method for treatment of opportunistic infections with pharmaceutical compositions of tizoxanide and nitazoxanide Claim Types: Method of use | JUL 03,2017 | U-523: Method of treating infection by Cryptosporidium Parvum in an immunocompromised mammal |
| Pat. No. 5968961 Pharmaceutical compositions of tizoxanide and nitazoxanide Claim Types: Formulation | MAY 07,2017 | |
| Pat. No. 6020353 2-(hydroxy)-N-(5-nitro-2-thiazolyl) benzamide Claim Types: Compound; Composition | SEP 08,2014 | |
| Pat. No. 6117894 Acid stabilized pharmaceutical compositions of tizoxanide and nitazoxanide Claim Types: Composition; Formulation | MAY 07,2017 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | JUN 16,2008 | I-460: Treatment of diarrhea caused by cryptosporidium parvum in non-HIV infected patients 12 years of age and older |
| Exclusivity Code: NCE - New chemical entity | NOV 22,2007 | |
| Exclusivity Code: NPP - New patient population | JUL 21,2007 | |
| Exclusivity Code ODE: Orphan Drug | NOV 22,2009 | Treatment of cryptosporidiosis. |
| Exclusivity Code ODE: Orphan Drug | NOV 22,2009 | Treatment of intestinal giardiasis. |
ALKERAN (INJECTABLE) MELPHALAN HYDROCHLORIDE
Drug Classes: ANTINEOPLASTICS; NSAID
NDA Applicant: GLAXOSMITHKLINE NDA No.: 020207 Prod. No.: 001 RX (EQ 50MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4997651 Pharmaceutical formulations Claim Types: Formulation; Process | NOV 18,2008 |
ALLEGRA (CAPSULE) FEXOFENADINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANTIHISTAMINES
NDA Applicant: SANOFI AVENTIS US NDA No.: 020625 Prod. No.: 001 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5578610 Piperidine derivatives Claim Types: Composition; Method of use | MAY 26,2014 *PED | U-192: Use in treating allergic reactions |
| Pat. No. 5738872 Pharmaceutical composition for piperidinoalkanol compounds Claim Types: Formulation; Product-by-process | AUG 28,2015 *PED | |
| Pat. No. 5855912 Pharmaceutical compositions for piperidinalkanol compounds Claim Types: Product-by-process; Formulation | AUG 28,2015 *PED | |
| Pat. No. 5932247 Pharmaceutical composition for piperidinoalkanol compounds Claim Types: Formulation; Product-by-process | AUG 28,2015 *PED | |
| Pat. No. 6037353 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | SEP 14,2017 *PED | U-138: Treatment of allergic rhinitis |
| Pat. No. 6113942 Pharmaceutical composition for piperidinoalkanol compounds Claim Types: Formulation | AUG 28,2015 *PED | |
| Pat. No. 6187791 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | NOV 11,2012 *PED | U-138: Treatment of allergic rhinitis |
| Pat. No. 6399632 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | NOV 11,2012 *PED | U-468: Method of using fexofenadine HCl in treating allergic rhinitis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Nov 12,2006 PED | M-25: Additional safety & pK information in children 6 months to less than 6 years of age added to pkg insert |
ALLEGRA (TABLET) FEXOFENADINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: COLD REMEDIES; ANTIHISTAMINES
NDA Applicant: SANOFI AVENTIS US NDA No.: 020872 Prod. No.: 001 RX (30MG); 002 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5578610 DS* DP* Piperidine derivatives Claim Types: Composition; Method of use | MAY 26,2014 *PED | U-139: Treatment of allergic reactions |
| Pat. No. 5855912 DP* Pharmaceutical compositions for piperidinalkanol compounds Claim Types: Product-by-process; Formulation | AUG 28,2015 *PED | |
| Pat. No. 5932247 DP* Pharmaceutical composition for piperidinoalkanol compounds Claim Types: Formulation; Product-by-process | AUG 28,2015 *PED | |
| Pat. No. 6037353 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | SEP 14,2017 *PED | U-138: Treatment of allergic rhinitis |
| Pat. No. 6113942 DP* Pharmaceutical composition for piperidinoalkanol compounds Claim Types: Formulation | AUG 28,2015 *PED | |
| Pat. No. 6187791 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | NOV 11,2012 *PED | U-138: Treatment of allergic rhinitis |
| Pat. No. 6399632 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | NOV 11,2012 *PED | U-468: Method of using fexofenadine HCl in treating allergic rhinitis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Nov 12,2006 PED | M-25: Additional safety & pK information in children 6 months to less than 6 years of age added to pkg insert |
ALLEGRA (TABLET) FEXOFENADINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: COLD REMEDIES; ANTIHISTAMINES
NDA Applicant: SANOFI AVENTIS US NDA No.: 020872 Prod. No.: 004 RX (180MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5578610 DS* DP* Piperidine derivatives Claim Types: Composition; Method of use | MAY 26,2014 *PED | U-139: Treatment of allergic reactions |
| Pat. No. 5855912 DP* Pharmaceutical compositions for piperidinalkanol compounds Claim Types: Product-by-process; Formulation | AUG 28,2015 *PED | |
| Pat. No. 5932247 DP* Pharmaceutical composition for piperidinoalkanol compounds Claim Types: Formulation; Product-by-process | AUG 28,2015 *PED | |
| Pat. No. 6037353 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | SEP 14,2017 *PED | U-138: Treatment of allergic rhinitis |
| Pat. No. 6113942 DP* Pharmaceutical composition for piperidinoalkanol compounds Claim Types: Formulation | AUG 28,2015 *PED | |
| Pat. No. 6187791 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | NOV 11,2012 *PED | U-138: Treatment of allergic rhinitis |
| Pat. No. 6399632 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | NOV 11,2012 *PED | U-468: Method of using fexofenadine HCl in treating allergic rhinitis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | OCT 13,2008 | D-101: Once daily in chronic idiopathic uticaria for adults and children 12 years of age and older |
| Exclusivity Code: M - Miscellaneous | Nov 12,2006 PED | M-25: Additional safety & pK information in children 6 months to less than 6 years of age added to pkg insert |
ALLEGRA D 24 HOUR (TABLET, EXTENDED RELEASE) FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
NDA Applicant: SANOFI AVENTIS US NDA No.: 021704 Prod. No.: 001 RX (180MG;240MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5578610 DS* DP* Piperidine derivatives Claim Types: Composition; Method of use | MAY 26,2014 *PED | U-612: Treatment of seasonal allergy symptoms with nasal congestion in adults and children 12 years of age and older |
| Pat. No. 6004582 DP* Multi-layered osmotic device Claim Types: Device | MAY 29,2018 | |
| Pat. No. 6037353 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | SEP 14,2017 *PED | U-612: Treatment of seasonal allergy symptoms with nasal congestion in adults and children 12 years of age and older |
| Pat. No. 6187791 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | NOV 11,2012 *PED | U-612: Treatment of seasonal allergy symptoms with nasal congestion in adults and children 12 years of age and older |
| Pat. No. 6399632 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | NOV 11,2012 *PED | U-612: Treatment of seasonal allergy symptoms with nasal congestion in adults and children 12 years of age and older |
| Pat. No. 6613357 DP* Osmotic device containing pseudoephedrine and an H1 antagonist Claim Types: Device; Method of use | DEC 25,2020 | U-612: Treatment of seasonal allergy symptoms with nasal congestion in adults and children 12 years of age and older |
| Pat. No. RE39069 DP* Multi-layered osmotic device Claim Types: Device | MAY 29,2018 |
ALLEGRA-D 12 HOUR (TABLET, EXTENDED RELEASE) FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: COLD REMEDIES
NDA Applicant: SANOFI AVENTIS US NDA No.: 020786 Prod. No.: 001 RX (60MG;120MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5578610 Piperidine derivatives Claim Types: Composition; Method of use | MAY 26,2014 *PED | |
| Pat. No. 5855912 Pharmaceutical compositions for piperidinalkanol compounds Claim Types: Product-by-process; Formulation | AUG 28,2015 *PED | |
| Pat. No. 6037353 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | SEP 14,2017 *PED | U-138: Treatment of allergic rhinitis |
| Pat. No. 6039974 Pharmaceutical composition for combination of piperidinoalkanol-decongestant Claim Types: Formulation | JUL 31,2018 | |
| Pat. No. 6113942 Pharmaceutical composition for piperidinoalkanol compounds Claim Types: Formulation | AUG 28,2015 *PED | |
| Pat. No. 6187791 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | NOV 11,2012 *PED | U-138: Treatment of allergic rhinitis |
| Pat. No. 6399632 Method of providing an antihistaminic effect in a hepatically impaired patient Claim Types: Method of use | NOV 11,2012 *PED | U-468: Method of using fexofenadine HCl in treating allergic rhinitis |
ALOCRIL (SOLUTION/DROPS) NEDOCROMIL SODIUM
Drug Classes: OPHTHALMICS-DECONGESTANTS/ANTIALLERGY AGENTS
NDA Applicant: ALLERGAN NDA No.: 021009 Prod. No.: 001 RX (2%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4474787 [Extended 5 years] 7,6 Dioxo-4H,6H-pyrano[3,2-g]quinoline dicarboxylic acids and anti-allergic use thereof Claim Types: Compound; Composition; Method of use | OCT 02,2006 | U-304: A method of treatment of a condition involving an antibody antigen reaction |
| Pat. No. RE38628 Pharmaceutical compositions Claim Types: Method of use | AUG 22,2012 | U-304: A method of treatment of a condition involving an antibody antigen reaction |
ALOMIDE (SOLUTION/DROPS) LODOXAMIDE TROMETHAMINE
Drug Classes: OPHTHALMICS, MISCELLANEOUS
NDA Applicant: ALCON NDA No.: 020191 Prod. No.: 001 RX (EQ 0.1% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5457126 Use of lodoxamide to treat ophthalmic allergic conditions Claim Types: Method of use | OCT 10,2012 | U-117: Treatment of ocular allergic response in human eyes |
ALORA (FILM, EXTENDED RELEASE) ESTRADIOL [Has competitive generic]
NDA Applicant: WATSON LABS NDA No.: 020655 Prod. No.: 001 RX (0.05MG/24HR); 002 RX (0.075MG/24HR); 003 RX (0.1MG/24HR); 004 RX (0.025MG/24HR)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5122383 Sorbitan esters as skin permeation enhancers Claim Types: Method of administration; Formulation | MAY 17,2011 | |
| Pat. No. 5164190 Subsaturated transdermal drug delivery device exhibiting enhanced drug flux Claim Types: Device; Method of administration | DEC 11,2010 | |
| Pat. No. 5212199 Sorbitan esters as skin permeation enhancers Claim Types: Method of improving a formulation; Formulation | MAY 17,2011 | |
| Pat. No. 5227169 Sorbitan esters as skin permeation enhancers Claim Types: Device | MAY 17,2011 |
ALOXI (INJECTABLE) PALONOSETRON HYDROCHLORIDE
Drug Classes: ANTIEMETICS
NDA Applicant: HELSINN HLTHCARE NDA No.: 021372 Prod. No.: 001 RX (EQ 0.25MG BASE/5ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5202333 Tricyclic 5-HT.sub.3 receptor antagonists Claim Types: Compound; Composition; Method of use | APR 13,2010 | U-528: Prevention of chemotherapy-induced nausea and vomiting |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | JUL 25,2008 |
ALPHAGAN P (SOLUTION/DROPS) BRIMONIDINE TARTRATE
Drug Classes: GLAUCOMA
NDA Applicant: ALLERGAN NDA No.: 021262 Prod. No.: 001 RX (0.15%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5424078 Aqueous ophthalmic formulations and methods for preserving same Claim Types: Formulation; Process | DEC 13,2012 *PED | |
| Pat. No. 6562873 Compositions containing therapeutically active components having enhanced solubility Claim Types: Formulation | JAN 10,2022 *PED | |
| Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components Claim Types: Formulation | JAN 18,2022 *PED | |
| Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation | JAN 28,2022 *PED | |
| Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation | JAN 26,2022 *PED |
ALPHAGAN P (SOLUTION/DROPS) BRIMONIDINE TARTRATE
NDA Applicant: ALLERGAN NDA No.: 021770 Prod. No.: 001 RX (0.1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5424078 DP* Aqueous ophthalmic formulations and methods for preserving same Claim Types: Formulation; Process | DEC 13,2012 *PED | |
| Pat. No. 6562873 DP* Compositions containing therapeutically active components having enhanced solubility Claim Types: Formulation | JAN 10,2022 *PED | |
| Pat. No. 6627210 DP* Compositions containing .alpha.-2-adrenergic agonist components Claim Types: Formulation | JAN 18,2022 *PED | |
| Pat. No. 6641834 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation | JAN 28,2022 *PED | |
| Pat. No. 6673337 DP* Compositions containing alpha-2-adrenergic agonist components Claim Types: Formulation | JAN 26,2022 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | AUG 19,2008 |
ALREX (SUSPENSION/DROPS) LOTEPREDNOL ETABONATE
Drug Classes: OPHTHALMICS-DECONGESTANTS/ANTIALLERGY AGENTS
NDA Applicant: BAUSCH AND LOMB NDA No.: 020803 Prod. No.: 001 RX (0.2%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4996335 [Extended 1473 days* (4 years)] Soft steroids having anti-inflammatory activity Claim Types: Compound; Composition; Method of use Comments: The form of this drug from Bausch & Lomb shows the correct expiration date for this patent. The form of this drug from Pharmos shows an expiration date that does not include the patent extension. The extended expiration date is March 9, 2012. | MAR 09,2012 | |
| Pat. No. 5540930 Suspension of loteprednol etabonate for ear, eye, or nose treatment Claim Types: Formulation | OCT 25,2013 | |
| Pat. No. 5747061 DP* Suspension of loteprednol etabonate for ear, eye, or nose treatment Claim Types: Formulation; Method of use | OCT 25,2013 | U-576: ALREX opthalmic suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis. |
ALTACE (CAPSULE) RAMIPRIL [GENERIC AB]
Drug Classes: ACE INHIBITORS; ANTIHYPERTENSIVES
NDA Applicant: KING PHARMS NDA No.: 019901 Prod. No.: 001 RX (1.25MG); 002 RX (2.5MG); 003 RX (5MG); 004 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5061722 Cis, endo-2-azabicyclo-[3.3.0]-octane-3-carboxylic acids, a process for their preparation, agents containing these compounds and their use Claim Types: Compound; Composition; Method of use | OCT 19,2008 | |
| Pat. No. 5403856 Method of treating cardiac insufficiency using angiotensin-converting enzyme inhibitors Claim Types: Method of use | APR 04,2012 | U-71: Method of treatment of heart failure |
ALTOPREV (TABLET, EXTENDED RELEASE) LOVASTATIN
NDA Applicant: ANDRX LABS LLC NDA No.: 021316 Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (40MG); 004 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5916595 HMG co-reductase inhibitor Claim Types: Formulation | DEC 12,2017 | |
| Pat. No. 6080778 Methods for decreasing beta amyloid protein Claim Types: Method of use | MAR 23,2018 | U-456: Method of decreasing the production of a-beta using a composition which decreases blood cholesterol in patients at risk of or exhibiting symptoms of Alzheimer's Disease |
| Pat. No. 6485748 DP* Once daily pharmaceutical tablet having a unitary core Claim Types: Formulation | DEC 12,2017 |
AMARYL (TABLET) GLIMEPIRIDE [GENERIC AB]
Drug Classes: BLOOD GLUCOSE REGULATORS
NDA Applicant: SANOFI AVENTIS US NDA No.: 020496 Prod. No.: 001 RX (1MG); 002 RX (2MG); 003 RX (4MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: M - Miscellaneous | May 28,2009 PED | M-54: Information from pediatric studies added to label |
AMBIEN (TABLET) ZOLPIDEM TARTRATE
Drug Classes: SEDATIVES/HYPNOTICS
NDA Applicant: SANOFI AVENTIS US NDA No.: 019908 Prod. No.: 001 RX (5MG); 002 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4382938 [Extended 5 years] Imidazo[1,2-a] pyridine derivatives and their application as pharmaceuticals Claim Types: Compound; Method of use | OCT 21,2006 | U-74: Method of providing hypnotic effect |
AMBIEN CR (TABLET, EXTENDED RELEASE) ZOLPIDEM TARTRATE
NDA Applicant: SANOFI AVENTIS US NDA No.: 021774 Prod. No.: 001 RX (12.5MG); 002 RX (6.25MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4382938 DS* [Extended 5 years] Imidazo[1,2-a] pyridine derivatives and their application as pharmaceuticals Claim Types: Compound; Method of use | OCT 21,2006 | U-682: Non-benzodiazepine hypnotic agent indicated for treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance |
| Pat. No. 6514531 DP* Controlled-release dosage forms comprising zolpidem or a salt thereof Claim Types: Formulation | DEC 01,2019 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NDF - New dosage form | SEP 02,2008 |
AMERGE (TABLET) NARATRIPTAN HYDROCHLORIDE
Drug Classes: ANTIMIGRAINE/OTHER HEADACHES
NDA Applicant: GLAXOSMITHKLINE NDA No.: 020763 Prod. No.: 001 RX (EQ 2.5MG BASE); 002 RX (EQ 1MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4997841 [Extended 694 days (1.9 years)] Indole derivatives Claim Types: Compound; Composition; Method of use | JUL 07,2010 | U-232: Method of treating migraine |
AMITIZA (CAPSULE) LUBIPROSTONE
NDA Applicant: SUCAMPO PHARMS NDA No.: 021908 Prod. No.: 001 RX (24UGM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5284858 DS* DP* Prostaglandins E and anti ulcers containing same Claim Types: Compound; Composition; Method of use | FEB 08,2011 | |
| Pat. No. 5317032 DS* DP* Prostaglandin cathartic Claim Types: Method of use | MAY 31,2011 | U-717: Method of relieving or preventing constipation in a human constipated patient |
| Pat. No. 6414016 DS* DP* Anti-constipation composition Claim Types: Method of use | SEP 05,2020 | U-717: Method of relieving or preventing constipation in a human constipated patient |
| Pat. No. 6583174 DS* DP* Composition and method for stabilizing the same Claim Types: Composition; Formulation; Process | OCT 16,2020 | |
| Pat. No. 7064148 DS* DP* Chloride channel opener Claim Types: Method of use | AUG 30,2022 | U-739: Method for treating constipation by opening CIC channels in a mammalian subject |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | JAN 31,2011 |
AMLEXANOX (PATCH) AMLEXANOX
NDA Applicant: ULURU NDA No.: 021727 Prod. No.: 001 RX (2MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NDF - New dosage form | SEP 29,2007 |
AMMONUL (SOLUTION) SODIUM BENZOATE; SODIUM PHENYLACETATE
NDA Applicant: UCYCLYD NDA No.: 020645 Prod. No.: 001 RX (10%;10% (5GM/50ML;5GM/50ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NDF - New dosage form | FEB 17,2008 | |
| Exclusivity Code ODE: Orphan Drug | FEB 17,2012 | For the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. |
AMPHADASE (INJECTABLE) HYALURONIDASE
NDA Applicant: AMPHASTAR PHARM NDA No.: 021665 Prod. No.: 001 RX (150 UNITS/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NCE - New chemical entity | OCT 26,2009 |
ANDRODERM (FILM, EXTENDED RELEASE) TESTOSTERONE
Drug Classes: ANDROGENS/ANABOLIC STEROIDS
NDA Applicant: WATSON LABS NDA No.: 020489 Prod. No.: 001 RX (2.5MG/24HR); 002 RX (5MG/24HR)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4849224 Device for administering an active agent to the skin or mucosa Claim Types: Device | NOV 12,2007 | |
| Pat. No. 4855294 Method for reducing skin irritation associated with drug/penetration enhancer compositions Claim Types: Formulation; Method of use | SEP 06,2008 | |
| Pat. No. 4863970 Penetration enhancement with binary system of oleic acid, oleins, and oleyl alcohol with lower alcohols Claim Types: Formulation | NOV 14,2006 | |
| Pat. No. 4983395 Device for administering an active agent to the skin or mucosa Claim Types: Device | NOV 12,2007 | |
| Pat. No. 5152997 Method and device for transdermally administering testosterone across nonscrotal skin at therapeutically effective levels Claim Types: Device; Method of use | DEC 11,2010 | U-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 5164190 Subsaturated transdermal drug delivery device exhibiting enhanced drug flux Claim Types: Device; Method of administration | DEC 11,2010 |
ANDROGEL (GEL) TESTOSTERONE [GENERIC AB]
Drug Classes: ANDROGENS/ANABOLIC STEROIDS
NDA Applicant: UNIMED PHARMS NDA No.: 021015 Prod. No.: 001 RX (1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6503894 Pharmaceutical composition and method for treating hypogonadism Claim Types: Formulation; Device; Method of administration | AUG 30,2020 | U-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
ANGELIQ (TABLET) DROSPIRENONE; ESTRADIOL
NDA Applicant: BERLEX NDA No.: 021355 Prod. No.: 002 RX (0.5MG;1MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6933395 DS* Processing For Producing Of Drospirenone (6beta, 7beta, 15beta, 16 beta-dimethylene-3-oxo-17alpha-pregn-4-en-21,17-Carbolactone, DRSP) as well as 7alpha-(3-hydoxy-1-proply)-6beta, 7beta 15beta, 16beta dimethylene-5 beta-androstane-3 beta, 5, 17-triol (ZK 92836 and 6 beta, 7 beta, 15 beta, 16 beta-dimethylene- 5 beta-hydroxy Claim Types: Composition; Product-by-process | AUG 11,2017 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | SEP 28,2008 |
ANGIOMAX (INJECTABLE) BIVALIRUDIN
NDA Applicant: MEDICINES CO NDA No.: 020873 Prod. No.: 001 RX (250MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5196404 Inhibitors of thrombin Claim Types: Compound; Composition; Method of use; Method of improving a treatment | MAR 23,2010 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | JUN 13,2008 | I-458: Use of bivalirudin for injection with provisional use of glycoprotein iib/iia inhibitor (GPI) as listed in the clinical trials replace-2 section for use as an anticoagulant in patients undergoing percutaneous coronary intervention (PCI) |
| Exclusivity Code: I - New Indication | NOV 30,2008 | I-486: ANGIOMAX is indicated for patients with, or at risk of, HIT/HITTS undergoing PCI |
ANTARA (MICRONIZED) (CAPSULE) FENOFIBRATE
NDA Applicant: OSCIENT NDA No.: 021695 Prod. No.: 001 RX (43MG); 003 RX (130MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4800079 DP* Medicine based on fenofibrate, and a method of preparing it Claim Types: Formulation | AUG 10,2007 | |
| Pat. No. 7101574 DS* DP* Pharmaceutical composition containing fenofibrate and the preparation method Claim Types: Formulation; Process | AUG 20,2020 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | OCT 21,2008 | M-47: Provides for use of ANTARA without regard to meals |
ANTARA (MICRONIZED) (CAPSULE) FENOFIBRATE
NDA Applicant: OSCIENT NDA No.: 021695 Prod. No.: 002 DISC (87MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4800079 DP* Medicine based on fenofibrate, and a method of preparing it Claim Types: Formulation | AUG 10,2007 |
ANTHELIOS SX (CREAM) AVOBENZONE; ECAMSULE; OCTOCRYLENE
NDA Applicant: LOREAL USA NDA No.: 021502 Prod. No.: 001 OTC (2%;2%;10%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4585597 DS* DP* [Extension length not available] 3-benzylidene-camphors, process for their preparation and their use in protection against UV rays Claim Types: Compound; Process; Composition; Formulation; Method of use | JUN 16,2007 | U-752: Sunscreen |
| Pat. No. 5587150 DP* Photostable cosmetic screening composition containing a UV-A screening agent and an alkyl .beta., .beta.-diphenylacrylate or .alpha.-cyano-.beta. , .beta.-diphenylacrylate Claim Types: Formulation; Method of use | DEC 24,2013 | U-752: Sunscreen |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NC - New combination | JUL 21,2009 |
ANTIZOL (INJECTABLE) FOMEPIZOLE
Drug Classes: ANTIDOTES, SPECIFIC
NDA Applicant: JAZZ NDA No.: 020696 Prod. No.: 001 RX (1GM/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code ODE: Orphan Drug | DEC 08,2007 | Treatment of methanol or ethylene glycol poisoning. |
ANZEMET (TABLET) DOLASETRON MESYLATE
Drug Classes: ANTIEMETICS
NDA Applicant: SANOFI AVENTIS US NDA No.: 020623 Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4906755 [Extended 1579 days (4.3 years)] Esters of hexahydro-8-hydroxy-2,6-methano-2H-quinolizin-3-(4H)-one and related compounds Claim Types: Compound | JUL 02,2011 |
ANZEMET (INJECTABLE) DOLASETRON MESYLATE
Drug Classes: ANTIEMETICS
NDA Applicant: SANOFI AVENTIS US NDA No.: 020624 Prod. No.: 001 RX (EQ 100MG BASE/5ML (EQ 20MG BASE/ML)); 002 RX (EQ 12.5MG BASE/0.625ML (EQ 20MG BASE/ML)); 003 RX (EQ 500MG BASE/25ML (EQ 20MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4906755 [Extended 1579 days (4.3 years)] Esters of hexahydro-8-hydroxy-2,6-methano-2H-quinolizin-3-(4H)-one and related compounds Claim Types: Compound | JUL 02,2011 |
APHTHASOL (PASTE) AMLEXANOX
Drug Classes: DENTAL PREPARATIONS
NDA Applicant: ULURU NDA No.: 020511 Prod. No.: 001 RX (5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5362737 Methods of treating aphthous ulcers and other mucocutaneous disorders with amlexanox Claim Types: Method of use | NOV 08,2011 | U-243: Topical administration |
APIDRA (INJECTABLE) INSULIN GLULISINE RECOMBINANT
NDA Applicant: SANOFI AVENTIS US NDA No.: 021629 Prod. No.: 001 RX (1000 UNITS/10ML (100 UNITS/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6221633 DS* DP* Insulin derivatives having a rapid onset of action Claim Types: Compound; Process; Composition; Intermediate | JUN 18,2018 | U-471: Method of treating a patient suffering from diabetes mellitus |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | APR 16,2009 |
APOKYN (INJECTABLE) APOMORPHINE HYDROCHLORIDE
NDA Applicant: VERNALIS NDA No.: 021264 Prod. No.: 001 RX (20MG/2ML (10MG/ML)); 002 RX (30MG/3ML (10MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: NCE - New chemical entity | APR 20,2009 | |
| Exclusivity Code ODE: Orphan Drug | APR 20,2011 | Treatment of the on-off fluctuations associated with late-stage Parkinson's disease. |
APTIVUS (CAPSULE) TIPRANAVIR
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 021814 Prod. No.: 001 RX (250MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5852195 DS* Pyranone compounds useful to treat retroviral infections Claim Types: Compound | DEC 22,2015 | |
| Pat. No. 6147095 Method for improving the pharmacokinetics of tipranavir Claim Types: Method of use | OCT 29,2019 | U-670: Treatment of HIV-1 infection by the co-administration of tipranavir and ritonavir. |
| Pat. No. 6169181 DS* Compounds useful to treat retroviral infections Claim Types: Compound | MAY 06,2014 | |
| Pat. No. 6231887 DP* Pharmaceutical composition for acidic lipophilic compounds in a form of a self-emulsifying formulation Claim Types: Formulation | JUL 27,2018 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | JUN 22,2010 |
ARAVA (TABLET) LEFLUNOMIDE [GENERIC AB]
Drug Classes: ANTIARTHRITICS
NDA Applicant: SANOFI AVENTIS US NDA No.: 020905 Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (100MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: I - New Indication | Dec 13,2006 PED | I-395: To improve physical function |
| Exclusivity Code: M - Miscellaneous | Sep 05,2007 PED | M-32: Additional language to clinical pharmacology and clinical studies |
ARGATROBAN (INJECTABLE) ARGATROBAN
Drug Classes: ANTICOAGULANTS/THROMBOLYTICS
NDA Applicant: ENCYSIVE NDA No.: 020883 Prod. No.: 001 RX (100MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5214052 [Extended 1497 days (4.1 years)] Method for dissolving arginineamides and pharmaceutical compositions containing them Claim Types: Formulation; Process | JUN 30,2014 |
ARICEPT (TABLET) DONEPEZIL HYDROCHLORIDE
Drug Classes: ALZHEIMER-TYPE DEMENTIA
NDA Applicant: EISAI MEDCL RES NDA No.: 020690 Prod. No.: 001 RX (10MG); 002 RX (5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4895841 [Extended 888 days* (2.4 years)] Cyclic amine compounds with activity against acetylcholinesterase Claim Types: Compound; Composition; Method of use | NOV 25,2010 | |
| Pat. No. 5985864 Polymorphs of donepezil hydrochloride and process for production Claim Types: New polymorph, salt or hydrate; Composition; Process; Method of use | DEC 30,2016 | |
| Pat. No. 6140321 Polymorphs of donepezil hydrochloride and process for production Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process | DEC 30,2016 | |
| Pat. No. 6245911 Donepezil polycrystals and process for producing the same Claim Types: New polymorph, salt or hydrate; Process | DEC 01,2018 | |
| Pat. No. 6372760 Stabilized composition comprising antidementia medicament Claim Types: Formulation; Method of improving a formulation | MAR 31,2019 |
ARICEPT ODT (TABLET, ORALLY DISINTEGRATING) DONEPEZIL HYDROCHLORIDE
NDA Applicant: EISAI MEDCL RES NDA No.: 021720 Prod. No.: 001 RX (5MG); 002 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4895841 DS* DP* [Extended 888 days* (2.4 years)] Cyclic amine compounds with activity against acetylcholinesterase Claim Types: Compound; Composition; Method of use | NOV 25,2010 | U-713: Treatment of mild to moderate dementia of the Alzheimer's type |
ARIMIDEX (TABLET) ANASTROZOLE
Drug Classes: ANTINEOPLASTICS
NDA Applicant: ASTRAZENECA NDA No.: 020541 Prod. No.: 001 RX (1MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE36617 (Substituted aralkyl) heterocyclic compounds Claim Types: Compound; Composition; Method of use | DEC 27,2009 |
ARIXTRA (INJECTABLE) FONDAPARINUX SODIUM
Drug Classes: ANTICOAGULANTS/THROMBOLYTICS
NDA Applicant: GLAXOSMITHKLINE NDA No.: 021345 Prod. No.: 001 RX (2.5MG/0.5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: I - New Indication | JUN 17,2006 | I-397: Extended prophylaxis in patients undergoing hip fracture surgery |
| Exclusivity Code: I - New Indication | MAY 31,2007 | I-426: Treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium |
| Exclusivity Code: I - New Indication | MAY 31,2007 | I-427: Treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium |
| Exclusivity Code: I - New Indication | MAY 26,2008 | I-457: Treatment of patients undergoing abdominal surgery who are at risk for thromboembolic complications |
| Exclusivity Code: NCE - New chemical entity | DEC 07,2006 |
ARIXTRA (INJECTABLE) FONDAPARINUX SODIUM
Drug Classes: ANTICOAGULANTS/THROMBOLYTICS
NDA Applicant: GLAXOSMITHKLINE NDA No.: 021345 Prod. No.: 002 RX (5MG/0.4ML); 003 RX (7.5MG/0.6ML); 004 RX (10MG/0.8ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Code: I - New Indication | JUN 17,2006 | I-397: Extended prophylaxis in patients undergoing hip fracture surgery |
| Exclusivity Code: I - New Indication | MAY 31,2007 | I-426: Treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium |
| Exclusivity Code: I - New Indication | MAY 31,2007 | I-427: Treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium |
| Exclusivity Code: I - New Indication | MAY 26,2008 | I-457: Treatment of patients undergoing abdominal surgery who are at risk for thromboembolic complications |
| Exclusivity Code: NCE - New chemical entity | DEC 07,2006 | |
| Exclusivity Code: NS - New strength | MAY 31,2007 |
AROMASIN (TABLET) EXEMESTANE
Drug Classes: HORMONAL/BIOLOGICAL RESPONSE MODIFIERS
NDA Applicant: PHARMACIA AND UPJOHN NDA No.: 020753 Prod. No.: 001 RX (25MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4808616 DS* DP* [Extended 1729 days (4.7 years)] 6-substituted androsta-1,4-diene-3,17-diones Claim Types: Compound; Composition; Method of use | APR 01,2011 | U-658: Treatment of advanced hormone-dependent breast cancer |
| Pat. No. 4904650 DS* DP* Substituted androsta-1,4-diene-3,17-diones Claim Types: Compound; Composition; Method of use | JUL 07,2006 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | OCT 05,2008 | I-495: Adjuvant tx of postmenopausal women with estrogen-receptor positive early breast cancer who have received 2 to 3 yrs of tamoxifen and are switched to AROMASIN for completion of a total of 5 consecutive yrs of adjuvant hormonal therapy |
| Exclusivity Code ODE: Orphan Drug | OCT 21,2006 | Treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. |
ARRANON (INJECTABLE) NELARABINE
NDA Applicant: SMITHKLINE BEECHAM NDA No.: 021877 Prod. No.: 001 RX (250MG/50ML (5MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5424295 DS* DP* 9-.beta.-D-arabinofuranasyl-2-amino-6-methaoxy-9H-purine Claim Types: Compound; Composition | JUN 13,2012 | |
| Pat. No. 5492897 Method for treating T-cell lymphoblastic leukemia with ara-G nucleoside derivatives Claim Types: Method of use | FEB 20,2013 | U-689: Treatment of patients with T-cell acute lymphoblastic leukemia whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens |
| Pat. No. 5747472 Therapeutic methods for using ARA-G derivatives Claim Types: Method of use | FEB 20,2013 | U-689: Treatment of patients with T-cell acute lymphoblastic leukemia whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens |
| Pat. No. 5747472 Therapeutic methods for using ARA-G derivatives Claim Types: Method of use | FEB 20,2013 | U-695: Treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens |
| Pat. No. 5747472 Therapeutic methods for using ARA-G derivatives Claim Types: Method of use | FEB 20,2013 | U-696: Treatment of patients with T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens |
| Pat. No. 5821236 Tumor treatment with arabinofuranosyl purine derivatives Claim Types: Method of use | FEB 20,2013 | U-695: Treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | OCT 28,2010 | |
| Exclusivity Code ODE: Orphan Drug | OCT 28,2012 | Treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded or has relapsed following treatment with at least two chemotherapy regimens. |
ARTHROTEC (TABLET, DELAYED RELEASE) DICLOFENAC SODIUM; MISOPROSTOL
Drug Classes: DISORDERS, ACID/PEPTIC; NSAID
NDA Applicant: SEARLE, GD LLC NDA No.: 020607 Prod. No.: 001 RX (50MG;0.2MG); 002 RX (75MG;0.2MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5601843 Pharmaceutical tablet composition Claim Types: Formulation; Method of use | FEB 11,2014 | |
| Pat. No. 5698225 Pharmaceutical composition Claim Types: Formulation; Method of use | MAY 03,2010 | U-392: Treatment of patients for inflammation |
ASACOL (TABLET, DELAYED RELEASE) MESALAMINE
Drug Classes: GASTROINTESTINAL, MISCELLANEOUS
NDA Applicant: PROCTER AND GAMBLE NDA No.: 019651 Prod. No.: 001 RX (400MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5541170 Orally administrable pharmaceutical compositions Claim Types: Formulation | JUL 30,2013 | U-141: Treatment of ulcerative colitis |
| Pat. No. 5541171 Orally administrable pharmaceutical composition Claim Types: Formulation; Method of use | JUL 30,2013 | U-141: Treatment of ulcerative colitis |
ASMANEX TWISTHALER (POWDER) MOMETASONE FUROATE
NDA Applicant: SCHERING NDA No.: 021067 Prod. No.: 001 RX (0.22MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5394868 DP* Inhalation device for powdered medicaments Claim Types: Device | JUN 25,2012 | |
| Pat. No. 5687710 DP* Inhaler for powdered medications having spiral deagglomeration chamber Claim Types: Device | NOV 18,2014 | |
| Pat. No. 5829434 DP* Inhaler for powdered medications Claim Types: Device | NOV 03,2015 | |
| Pat. No. 5889015 Use of mometasone furoate for treating lower airway passage and lung diseases Claim Types: Method of use | JAN 27,2014 | U-645: Treatment of asthma |
| Pat. No. 6057307 DP* Use of mometasone furoate for treating airway passage and lung diseases Claim Types: Method of use; Drug in a container | JAN 27,2014 | U-645: Treatment of asthma |
| Pat. No. 6240918 DP* Powdered medication inhaler Claim Types: Device | FEB 20,2017 | |
| Pat. No. 6365581 Use of mometasone furoate for treating airway passage and lung diseases Claim Types: Method of use | JAN 27,2014 | U-645: Treatment of asthma |
| Pat. No. 6503537 DP* Preparation of powder agglomerates Claim Types: Process; Composition; Product-by-process; Device | MAR 17,2018 | |
| Pat. No. 6677322 Use of mometasone furoate for treating airway passage and lung diseases Claim Types: Method of use | JAN 27,2014 | U-645: Treatment of asthma |
| Pat. No. 6949532 Use of mometasone furoate for treating airway passage and lung diseases Claim Types: Method of use | JAN 27,2014 | U-645: Treatment of asthma |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | MAR 30,2008 |
ASTELIN (SPRAY, METERED) AZELASTINE HYDROCHLORIDE
Drug Classes: ANTIHISTAMINES
NDA Applicant: MEDPOINTE PHARM HLC NDA No.: 020114 Prod. No.: 001 RX (EQ 0.125MG BASE/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5164194 [Extended 349 days* (1 years)] Azelastine containing medicaments Claim Types: Method of use | MAY 01,2011 *PED | U-207: Use as nasal spray |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | FEB 17,2009 | D-102: New dosing regimen of one spray twice daily for seasonal alleric rhinitis in patients 12 yrs of age and older |
ATACAND (TABLET) CANDESARTAN CILEXETIL
Drug Classes: ANTIHYPERTENSIVES
NDA Applicant: ASTRAZENECA NDA No.: 020838 Prod. No.: 001 RX (4MG); 002 RX (8MG); 003 RX (16MG); 004 RX (32MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5196444 DS* DP* [Extended 413 days* (1.1 years)] 1-(cyclohexyloxycarbonyloxy)ethyl 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl] benzimidazole-7-carboxylate and compositions and methods of pharmaceutical use thereof Claim Types: Composition; Method of use | JUN 04,2012 | U-3: Treatment of hypertension |
| Pat. No. 5196444 DS* DP* [Extended 413 days* (1.1 years)] 1-(cyclohexyloxycarbonyloxy)ethyl 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl] benzimidazole-7-carboxylate and compositions and methods of pharmaceutical use thereof Claim Types: Composition; Method of use | JUN 04,2012 | U-660: Treatment of hypertension and treatment of heart failure |
| Pat. No. 5534534 DP* Pharmaceutical compositions for oral use and method of preparing them Claim Types: Formulation | JUL 09,2013 | |
| Pat. No. 5705517 DS* DP* Benzimidazole derivatives and use thereof Claim Types: Compound; Composition; Method of use | APR 18,2011 | U-660: Treatment of hypertension and treatment of heart failure |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | FEB 22,2008 | I-448: Treatment of heart failure (NYHA class ii-iv and ejection fraction <=40%) to reduce the risk of death from cardiovascular causes and to reduce hospitalizations for heart failure |
| Exclusivity Code: I - New Indication | MAY 18,2008 | I-455: Modified heart failure indication to include treatment of heart failure in patients with left ventricular systolic dysfunction (NYHA class II-IV; ejection fraction less than or equal to 40% |
| Exclusivity Code: I - New Indication | MAY 18,2008 | I-456: To reduce cardiovascular death and to reduce heart failure hospitalizations. includes additional information on the added effect on these outcomes when used with an ACE inhibitor |
ATACAND HCT (TABLET) CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
NDA Applicant: ASTRAZENECA NDA No.: 021093 Prod. No.: 001 RX (16MG;12.5MG); 002 RX (32MG;12.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5196444 [Extended 413 days* (1.1 years)] 1-(cyclohexyloxycarbonyloxy)ethyl 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl] benzimidazole-7-carboxylate and compositions and methods of pharmaceutical use thereof Claim Types: Composition; Method of use | JUN 04,2012 | U-3: Treatment of hypertension |
| Pat. No. 5534534 Pharmaceutical compositions for oral use and method of preparing them Claim Types: Formulation | JUL 09,2013 | |
| Pat. No. 5703110 Benzimidazole derivatives, their production and use Claim Types: Compound; Composition; Method of use | APR 18,2011 | U-3: Treatment of hypertension |
| Pat. No. 5705517 Benzimidazole derivatives and use thereof Claim Types: Compound; Composition; Method of use | APR 18,2011 | U-3: Treatment of hypertension |
| Pat. No. 5721263 Pharmaceutical composition for angiotensin II-mediated diseases Claim Types: Composition; Method of use | FEB 24,2015 | U-3: Treatment of hypertension |
| Pat. No. 5958961 Pharmaceutical composition for angiotensin II-mediated diseases Claim Types: Composition; Method of use | JUN 06,2014 | U-3: Treatment of hypertension |
ATRIPLA (TABLET) EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
NDA Applicant: GILEAD NDA No.: 021937 Prod. No.: 001 RX (600MG;200MG;300MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5210085 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds Claim Types: Method of use | NOV 11,2010 *PED | U-750: Treatment of hiv-1 infection in adults |
| Pat. No. 5519021 DS* DP* Benzoxazinones as inhibitors of HIV reverse transcriptase Claim Types: Compound; Composition | MAY 21,2013 | |
| Pat. No. 5663169 Benzoxazinones as inhibitors of HIV reverse transcriptase Claim Types: Method of use | SEP 02,2014 | U-750: Treatment of hiv-1 infection in adults |
| Pat. No. 5811423 Benzoxazinones as inhibitors of HIV reverse transcriptase Claim Types: Method of use | AUG 07,2012 | U-750: Treatment of hiv-1 infection in adults |
| Pat. No. 5814639 DS* DP* Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds Claim Types: Compound; Composition | MAR 29,2016 *PED | |
| Pat. No. 5914331 DS* Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Compound; Composition | MAR 29,2016 *PED | |
| Pat. No. 5922695 DS* Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability Claim Types: Compound; Method of use; Process | JUL 25,2017 | U-750: Treatment of hiv-1 infection in adults |
| Pat. No. 5935946 DS* DP* Nucleotide analog composition and synthesis method Claim Types: Compound; Composition; Product-by-process; Method of use; Process | JUL 25,2017 | U-750: Treatment of hiv-1 infection in adults |
| Pat. No. 5977089 DS* DP* Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Claim Types: Compound; Composition; Method of use | JUL 25,2017 | U-750: Treatment of hiv-1 infection in adults |
| Pat. No. 6043230 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability Claim Types: Method of use | JUL 25,2017 | U-750: Treatment of hiv-1 infection in adults |
| Pat. No. 6238695 DP* Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants Claim Types: Formulation; Process | APR 06,2019 | |
| Pat. No. 6555133 Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants Claim Types: Method of use | APR 06,2019 | U-750: Treatment of hiv-1 infection in adults |
| Pat. No. 6639071 DS* Crystal Forms of (-)-6-chloro-4-cyclopropylethynyl-4- trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one Claim Types: New polymorph, salt or hydrate | NOV 13,2021 | |
| Pat. No. 6642245 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane Claim Types: Method of use | MAY 04,2021 *PED | U-750: Treatment of hiv-1 infection in adults |
| Pat. No. 6703396 DS* DP* Method of resolution and antiviral activity of 1,3-oxathiolane nuclesoside enantiomers Claim Types: Compound; Formulation | SEP 09,2021 *PED | |
| Pat. No. 6939964 DS* Crystal forms of (-)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-2H-3,1-benzoxazin-2-one Claim Types: New polymorph, salt or hydrate | JAN 20,2018 |
ATROVENT HFA (AEROSOL, METERED) IPRATROPIUM BROMIDE
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 021527 Prod. No.: 001 RX (0.021MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5676930 DP* Stabilized medicinal aerosol solution formulations Claim Types: Formulation; Process | OCT 14,2014 | |
| Pat. No. 5683677 DP* Medicinal aerosol formulations Claim Types: Formulation | NOV 04,2014 | |
| Pat. No. 5695743 DP* Medicinal aerosol formulations Claim Types: Formulation; Method of administration; Method of use | JUL 06,2010 | U-610: ATROVENT HFA (ipratropium bromide HFA) inhalation aerosol is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. |
| Pat. No. 5766573 Medicinal aerosol formulations Claim Types: Method of administration | NOV 28,2009 | U-610: ATROVENT HFA (ipratropium bromide HFA) inhalation aerosol is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. |
| Pat. No. 6739333 DP* Stainless steel canister for propellant-driven metering aerosols Claim Types: Device | MAY 26,2020 | |
| Pat. No. 6983743 DP* Stainless steel canister for propellant-driven metering aerosols Claim Types: Device | MAY 26,2020 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | NOV 17,2007 |
AVAGARD (SOLUTION) ALCOHOL; CHLORHEXIDINE GLUCONATE
NDA Applicant: 3M NDA No.: 021074 Prod. No.: 001 OTC (61%;1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5897031 Dispenser for antimicrobial liquids Claim Types: Device; Method of using a device | JUN 21,2016 |
AVALIDE (TABLET) HYDROCHLOROTHIAZIDE; IRBESARTAN
Drug Classes: ANTIHYPERTENSIVES; DIURETICS
NDA Applicant: SANOFI AVENTIS US NDA No.: 020758 Prod. No.: 002 RX (12.5MG;150MG); 003 RX (12.5MG;300MG) NDA No.: 020758 Prod. No.: 001 DISC (12.5MG;75MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5270317 [Extended 194 days* (0.5 years)] N-substituted heterocyclic derivatives, their preparation and the pharmaceutical compositions in which they are present Claim Types: Compound; Composition | MAR 30,2012 *PED | |
| Pat. No. 5994348 Pharmaceutical compositions containing irbesartan Claim Types: Formulation | DEC 07,2015 *PED |
AVALIDE (TABLET) HYDROCHLOROTHIAZIDE; IRBESARTAN
Drug Classes: ANTIHYPERTENSIVES; DIURETICS
NDA Applicant: SANOFI AVENTIS US NDA No.: 020758 Prod. No.: 004 RX (25MG;300MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5270317 DS* DP* [Extended 194 days* (0.5 years)] N-substituted heterocyclic derivatives, their preparation and the pharmaceutical compositions in which they are present Claim Types: Compound; Composition | MAR 30,2012 *PED | |
| Pat. No. 5994348 DP* Pharmaceutical compositions containing irbesartan Claim Types: Formulation | DEC 07,2015 *PED |
AVANDAMET (TABLET) METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Drug Classes: BLOOD GLUCOSE REGULATORS
NDA Applicant: SB PHARMCO NDA No.: 021410 Prod. No.: 001 RX (500MG;EQ 1MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5002953 DS* DP* [Extended 1113 days (3 years)] Novel compounds Claim Types: Compound; Composition; Method of use | MAR 17,2012 *PED | U-691: Use as a monotherapy, in combination with a sulfonylurea, metformin or insulin or in combination with a sulfonylurea plus metformin to improve glycemic control in patients with type 2 diabetes mellitus |
| Pat. No. 5741803 DS* DP* Substituted thiazolidinedionle derivatives Claim Types: Compound; Method of use | OCT 21,2015 *PED | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 5965584 Pharmaceutical composition Claim Types: Composition; Method of use | JUN 19,2016 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 6166042 Pharmaceutical composition Claim Types: Method of use | JUN 19,2016 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 6288095 Compounds Claim Types: Composition; Method of use; Process | AUG 11,2017 *PED | U-493: Treatment of Type 2 Diabetes Mellitus |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | MAY 19,2009 | I-494: Clinical data in support of AVANDAMET as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus when treatment with dual rosiglitazone and metformin therapy is appropriate |
AVANDAMET (TABLET) METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Drug Classes: BLOOD GLUCOSE REGULATORS
NDA Applicant: SB PHARMCO NDA No.: 021410 Prod. No.: 002 RX (500MG;EQ 2MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5002953 DS* DP* [Extended 1113 days (3 years)] Novel compounds Claim Types: Compound; Composition; Method of use | MAR 17,2012 *PED | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 5741803 DS* DP* Substituted thiazolidinedionle derivatives Claim Types: Compound; Method of use | OCT 21,2015 *PED | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 5965584 Pharmaceutical composition Claim Types: Composition; Method of use | JUN 19,2016 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 6166042 Pharmaceutical composition Claim Types: Method of use | JUN 19,2016 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 6288095 Compounds Claim Types: Composition; Method of use; Process | AUG 11,2017 *PED | U-493: Treatment of Type 2 Diabetes Mellitus |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | MAY 19,2009 | I-494: Clinical data in support of AVANDAMET as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus when treatment with dual rosiglitazone and metformin therapy is appropriate |
AVANDAMET (TABLET) METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Drug Classes: BLOOD GLUCOSE REGULATORS
NDA Applicant: SB PHARMCO NDA No.: 021410 Prod. No.: 003 RX (500MG;EQ 4MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5002953 DS* DP* [Extended 1113 days (3 years)] Novel compounds Claim Types: Compound; Composition; Method of use | MAR 17,2012 *PED | U-690: To improve glycemic control in patients with type 2 diabetes mellitus |
| Pat. No. 5741803 DS* DP* Substituted thiazolidinedionle derivatives Claim Types: Compound; Method of use | OCT 21,2015 *PED | U-734: First line therapy for type 2 diabetes mellitus |
| Pat. No. 5965584 Pharmaceutical composition Claim Types: Composition; Method of use | JUN 19,2016 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 6166042 Pharmaceutical composition Claim Types: Method of use | JUN 19,2016 | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 6288095 Compounds Claim Types: Composition; Method of use; Process | AUG 11,2017 *PED | U-493: Treatment of Type 2 Diabetes Mellitus |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | MAY 19,2009 | I-494: Clinical data in support of AVANDAMET as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus when treatment with dual rosiglitazone and metformin therapy is appropriate |
AVANDAMET (TABLET) METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Drug Classes: BLOOD GLUCOSE REGULATORS
NDA Applicant: SB PHARMCO NDA No.: 021410 Prod. No.: 004 RX (1GM;EQ 2MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5002953 DS* DP* [Extended 1113 days (3 years)] Novel compounds Claim Types: Compound; Composition; Method of use | MAR 17,2012 *PED | U-734: First line therapy for type 2 diabetes mellitus |
| Pat. No. 5741803 DS* DP* Substituted thiazolidinedionle derivatives Claim Types: Compound; Method of use | OCT 21,2015 *PED | U-493: Treatment of Type 2 Diabetes Mellitus |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | MAY 19,2009 | I-494: Clinical data in support of AVANDAMET as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus when treatment with dual rosiglitazone and metformin therapy is appropriate |
AVANDAMET (TABLET) METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Drug Classes: BLOOD GLUCOSE REGULATORS
NDA Applicant: SB PHARMCO NDA No.: 021410 Prod. No.: 005 RX (1GM;EQ 4MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5002953 DS* DP* [Extended 1113 days (3 years)] Novel compounds Claim Types: Compound; Composition; Method of use | MAR 17,2012 *PED | U-690: To improve glycemic control in patients with type 2 diabetes mellitus |
| Pat. No. 5741803 DS* DP* Substituted thiazolidinedionle derivatives Claim Types: Compound; Method of use | OCT 21,2015 *PED | U-734: First line therapy for type 2 diabetes mellitus |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | MAY 19,2009 | I-494: Clinical data in support of AVANDAMET as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus when treatment with dual rosiglitazone and metformin therapy is appropriate |
AVANDARYL (TABLET) GLIMEPIRIDE; ROSIGLITAZONE MALEATE
NDA Applicant: SB PHARMCO NDA No.: 021700 Prod. No.: 001 RX (1MG;4MG); 002 RX (2MG;4MG); 003 RX (4MG;4MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5002953 DS* DP* [Extended 1113 days (3 years)] Novel compounds Claim Types: Compound; Composition; Method of use | MAR 17,2012 *PED | U-690: To improve glycemic control in patients with type 2 diabetes mellitus |
| Pat. No. 5741803 DS* DP* Substituted thiazolidinedionle derivatives Claim Types: Compound; Method of use | OCT 21,2015 *PED | U-690: To improve glycemic control in patients with type 2 diabetes mellitus |
AVANDIA (TABLET) ROSIGLITAZONE MALEATE
Drug Classes: BLOOD GLUCOSE REGULATORS
NDA Applicant: SB PHARMCO NDA No.: 021071 Prod. No.: 002 RX (EQ 2MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5002953 DS* DP* [Extended 1113 days (3 years)] Novel compounds Claim Types: Compound; Composition; Method of use | MAR 17,2012 *PED | U-628: Use of AVANDIA in combination with a sulfonylurea, and in combination with metformin and a sulfonylurea to improve glycemic control in patients with type 2 diabetes mellitus |
| Pat. No. 5741803 DS* DP* Substituted thiazolidinedionle derivatives Claim Types: Compound; Method of use | OCT 21,2015 *PED | U-628: Use of AVANDIA in combination with a sulfonylurea, and in combination with metformin and a sulfonylurea to improve glycemic control in patients with type 2 diabetes mellitus |
| Pat. No. 6288095 Compounds Claim Types: Composition; Method of use; Process | AUG 11,2017 *PED | U-420: Method of treatment of Type II diabetes |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Aug 27,2006 PED | I-384: Use in combination with insulin for the treatment of patients with Type 2 diabetes mellitus |
| Exclusivity Code: I - New Indication | FEB 28,2008 | I-453: Use in combination with a sulfonylurea plus metformin when diet, exercise and both agents do not result in adequate glycemic control (triple therapy) |
AVANDIA (TABLET) ROSIGLITAZONE MALEATE
Drug Classes: BLOOD GLUCOSE REGULATORS
NDA Applicant: SB PHARMCO NDA No.: 021071 Prod. No.: 003 RX (EQ 4MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5002953 DS* DP* [Extended 1113 days (3 years)] Novel compounds Claim Types: Compound; Composition; Method of use | MAR 17,2012 *PED | U-329: Use of AVANDIA as monotherapy, in combination with metformin, and in combination with sulfonylureas to improve glycemic control in patients with type 2 diabetes mellitus |
| Pat. No. 5741803 DS* DP* Substituted thiazolidinedionle derivatives Claim Types: Compound; Method of use | OCT 21,2015 *PED | U-628: Use of AVANDIA in combination with a sulfonylurea, and in combination with metformin and a sulfonylurea to improve glycemic control in patients with type 2 diabetes mellitus |
| Pat. No. 6288095 Compounds Claim Types: Composition; Method of use; Process | AUG 11,2017 *PED | U-420: Method of treatment of Type II diabetes |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Aug 27,2006 PED | I-384: Use in combination with insulin for the treatment of patients with Type 2 diabetes mellitus |
| Exclusivity Code: I - New Indication | FEB 28,2008 | I-453: Use in combination with a sulfonylurea plus metformin when diet, exercise and both agents do not result in adequate glycemic control (triple therapy) |
AVANDIA (TABLET) ROSIGLITAZONE MALEATE
Drug Classes: BLOOD GLUCOSE REGULATORS
NDA Applicant: SB PHARMCO NDA No.: 021071 Prod. No.: 004 RX (EQ 8MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5002953 DS* DP* [Extended 1113 days (3 years)] Novel compounds Claim Types: Compound; Composition; Method of use | MAR 17,2012 *PED | U-628: Use of AVANDIA in combination with a sulfonylurea, and in combination with metformin and a sulfonylurea to improve glycemic control in patients with type 2 diabetes mellitus |
| Pat. No. 5741803 DS* DP* Substituted thiazolidinedionle derivatives Claim Types: Compound; Method of use | OCT 21,2015 *PED | U-329: Use of AVANDIA as monotherapy, in combination with metformin, and in combination with sulfonylureas to improve glycemic control in patients with type 2 diabetes mellitus |
| Pat. No. 6288095 Compounds Claim Types: Composition; Method of use; Process | AUG 11,2017 *PED | U-420: Method of treatment of Type II diabetes |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Aug 27,2006 PED | I-384: Use in combination with insulin for the treatment of patients with Type 2 diabetes mellitus |
| Exclusivity Code: I - New Indication | FEB 28,2008 | I-453: Use in combination with a sulfonylurea plus metformin when diet, exercise and both agents do not result in adequate glycemic control (triple therapy) |
AVAPRO (TABLET) IRBESARTAN
Drug Classes: ANTIHYPERTENSIVES
NDA Applicant: SANOFI AVENTIS US NDA No.: 020757 Prod. No.: 001 RX (75MG); 002 RX (150MG); 003 RX (300MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5270317 [Extended 194 days* (0.5 years)] N-substituted heterocyclic derivatives, their preparation and the pharmaceutical compositions in which they are present Claim Types: Compound; Composition | MAR 30,2012 *PED | |
| Pat. No. 6342247 Pharmaceutical compositions containing irbesartan Claim Types: Formulation | DEC 07,2015 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Mar 17,2006 PED | I-373: Treatment of Type 2 diabetic nephropathy |
AVELOX (TABLET) MOXIFLOXACIN HYDROCHLORIDE
Drug Classes: QUINOLONES/DERIVATIVES
NDA Applicant: BAYER PHARMS NDA No.: 021085 Prod. No.: 001 RX (EQ 400MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4990517 DS* DP* [Extended 901 days (2.5 years)] 7-(1-pyrrolidinyl)-3-quinolone- and -naphthyridonecarboxylic acid derivatives as antibacterial agents and feed additives Claim Types: Compound; Composition; Method of use | DEC 08,2011 | U-298: Method of combating bacteria in a patient |
| Pat. No. 5607942 7-(1-pyrrolidinyl)-3-quinolone- and - naphthyridone-carboxylic acid derivatives as antibacterial agents and feed additives Claim Types: Compound; Composition; Method of use | MAR 04,2014 | U-298: Method of combating bacteria in a patient |
| Pat. No. 5849752 Crystal modification of CDCH a process for its preparation and pharmaceutical formulations comprising this modification Claim Types: New polymorph, salt or hydrate; Composition; Method of use | DEC 05,2016 | U-298: Method of combating bacteria in a patient |
| Pat. No. 6610327 DP* Pharmaceutical moxifloxacin preparation Claim Types: Formulation; Process; Method of use | OCT 29,2019 | U-298: Method of combating bacteria in a patient |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | FEB 28,2006 | I-385: Modification of the indication for Community Acquired Pneumonia to add "including penicillin-resistant strains, MIC penicillin >=2mcg/ml to streptococcus pneumoniae |
| Exclusivity Code: I - New Indication | JUN 13,2008 | I-477: Treatment of complicated skin and skin structure infections caused by methicillin susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae |
| Exclusivity Code: I - New Indication | NOV 18,2008 | I-479: Treatment of complicated intra-abdominal infections caused by E.coli, B. fragilis, S.anginosus, S.constellatus, E. faecalis, P. mirabilis, C. perfringens, B. thetaiotaomicron or peptostreptococcus species |
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER (INJECTABLE) MOXIFLOXACIN HYDROCHLORIDE
Drug Classes: ANTIBACTERIALS, MISCELLANEOUS
NDA Applicant: BAYER PHARMS NDA No.: 021277 Prod. No.: 001 RX (160MG/100ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4990517 DS* DP* [Extended 901 days (2.5 years)] 7-(1-pyrrolidinyl)-3-quinolone- and -naphthyridonecarboxylic acid derivatives as antibacterial agents and feed additives Claim Types: Compound; Composition; Method of use | DEC 08,2011 | U-298: Method of combating bacteria in a patient |
| Pat. No. 5607942 7-(1-pyrrolidinyl)-3-quinolone- and - naphthyridone-carboxylic acid derivatives as antibacterial agents and feed additives Claim Types: Compound; Composition; Method of use | MAR 04,2014 | U-298: Method of combating bacteria in a patient |
| Pat. No. 5849752 Crystal modification of CDCH a process for its preparation and pharmaceutical formulations comprising this modification Claim Types: New polymorph, salt or hydrate; Composition; Method of use | DEC 05,2016 | U-298: Method of combating bacteria in a patient |
| Pat. No. 6548079 DP* Moxifloxacin formulation containing common salt Claim Types: Formulation; Process; Method of use | JUL 25,2020 | U-298: Method of combating bacteria in a patient |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | FEB 28,2006 | I-385: Modification of the indication for Community Acquired Pneumonia to add "including penicillin-resistant strains, MIC penicillin >=2mcg/ml to streptococcus pneumoniae |
| Exclusivity Code: I - New Indication | JUN 13,2008 | I-477: Treatment of complicated skin and skin structure infections caused by methicillin susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae |
| Exclusivity Code: I - New Indication | NOV 18,2008 | I-479: Treatment of complicated intra-abdominal infections caused by E.coli, B. fragilis, S.anginosus, S.constellatus, E. faecalis, P. mirabilis, C. perfringens, B. thetaiotaomicron or peptostreptococcus species |
AVINZA (CAPSULE, EXTENDED RELEASE) MORPHINE SULFATE
Drug Classes: ANALGESICS, GENERAL
NDA Applicant: LIGAND NDA No.: 021260 Prod. No.: 001 RX (30MG); 002 RX (60MG); 003 RX (90MG); 004 RX (120MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6066339 Oral morphine multiparticulate formulation Claim Types: Formulation | NOV 25,2017 |
AVITA (CREAM) TRETINOIN [GENERIC AB]
Drug Classes: ACNE PRODUCTS; DERMATOLOGICS
NDA Applicant: MYLAN BERTEK NDA No.: 020404 Prod. No.: 003 RX (0.025%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 4971800 Method and compositions for enhancing the cutaneous penetration of pharmacologically active agents Claim Types: Excipient; Method of administration | NOV 20,2007 | U-178: Facilitated adherence of agents to skin |
| Pat. No. 5045317 Enhancing the cutaneous penetration of pharmacologically active agents Claim Types: Formulation | SEP 03,2008 | U-179: Enhanced cutaneous penetration of a dermally-applied pharmacologically active agent |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code ODE: Orphan Drug | JUN 04,2008 |
AVODART (CAPSULE) DUTASTERIDE
NDA Applicant: GLAXOSMITHKLINE NDA No.: 021319 Prod. No.: 001 RX (0.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5565467 Androstenone derivative Claim Types: Compound; Composition | OCT 15,2013 | |
| Pat. No. 5846976 Androstenone derivative Claim Types: Method of use | SEP 17,2013 | U-476: Method of treating androgen responsive/mediated condition in mammal by admin a safe, effective amount of dutasteride or pharmaceutically acceptable derivative thereof. Conditions include benign prostatic hypertrophy |
| Pat. No. 5998427 DS* Androstenones Claim Types: Compound; Composition; Method of use | SEP 17,2013 | U-477: Method of inhibiting 5-alpha testosterone reductase enzyme with dutasteride or its derivative and treating androgen responsive/mediated disease including benign prostatic hyperplasia |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | NOV 20,2006 |
AXERT (TABLET) ALMOTRIPTAN MALATE
NDA Applicant: ORTHO MCNEIL PHARM NDA No.: 021001 Prod. No.: 001 RX (EQ 6.25MG BASE); 002 RX (EQ 12.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5565447 [Extended 569 days (1.6 years)] Indole derivatives Claim Types: Compound; Method of use Comments: This patent was extended under Sec. 156; expiration date includes the extension | MAY 07,2015 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | MAY 07,2006 |
AXID (SOLUTION) NIZATIDINE
NDA Applicant: BRAINTREE NDA No.: 021494 Prod. No.: 001 RX (15MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6930119 DP* Liquid pharmaceutical composition Claim Types: Formulation | JUL 17,2022 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NDF - New dosage form | MAY 25,2007 |
AZILECT (TABLET) RASAGILINE MESYLATE
NDA Applicant: TEVA NDA No.: 021641 Prod. No.: 001 RX (EQ 0.5MG BASE); 002 RX (EQ 1MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5387612 Use of the R-enantiomers of N-propargyl-1-aminoindan compounds for treating Parkinson's disease Claim Types: Method of use | FEB 07,2012 | U-219: Treatment of Parkinson's disease |
| Pat. No. 5453446 Use of the R-enantiomers of N-propargyl 1-aminoindan compounds for treating Parkinson's disease. Claim Types: Method of use | FEB 07,2012 | U-219: Treatment of Parkinson's disease |
| Pat. No. 5457133 DS* DP* R-enantiomers of N-propargyl-aminoindan compounds, their preparation and pharmaceutical compositions containing them Claim Types: Compound; Composition; Formulation | FEB 07,2012 | |
| Pat. No. 5532415 DS* R-enantiomer of N-propargyl-1-aminoindan, salts, compositions and uses thereof Claim Types: Compound | JUL 02,2013 | |
| Pat. No. 5786390 DP* Pharmaceutical compositions of the R-enantiomer of N-propargyl -1-aminoindan Claim Types: Composition; Formulation | FEB 07,2012 | |
| Pat. No. 6126968 DP* Stable compositions containing N-propargyl-1-aminoindan Claim Types: Formulation | SEP 18,2016 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | MAY 16,2011 |
AZOPT (SUSPENSION/DROPS) BRINZOLAMIDE
Drug Classes: GLAUCOMA
NDA Applicant: ALCON NDA No.: 020816 Prod. No.: 001 RX (1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 5240923 Sulfonamides useful as carbonic anhydrase inhibitors Claim Types: Compound; Formulation; Method of use | MAR 01,2011 *PED | U-224: Controlling intraocular pressure |
| Pat. No. 5378703 [Extended 723 days* (2 years)] Sulfonamides useful as carbonic anhydrase inhibitors Claim Types: Compound; Composition; Method of use | OCT 01,2012 *PED | U-224: Controlling intraocular pressure |
| Pat. No. 5461081 Topical ophthalmic pharmaceutical vehicles Claim Types: Excipient; Method of administration | APR 24,2013 *PED | U-225: Method for delivery |