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 do |