Tradenames starting with "A"

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.


ABILIFY (TABLET) ARIPIPRAZOLE
Drug Classes: ANTIPSYCHOTICS/ANTIMANICS
NDA Applicant: OTSUKA      NDA No.:
021436  Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG); 005 RX (5MG); 006 RX (2MG)
PatentsExpirationPatented Use
Pat. No. 5006528 DS* DP* [Extended 5 years]
Carbostyril derivatives
Claim Types: Compound; Composition
OCT 20,2014 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationAUG 28,2006I-401: Longer-term efficacy of aripiprazole in the treatment of schizophrenia
Exclusivity Code: I - New IndicationSEP 29,2007I-437: Treatment of acute manic and mixed episodes associated with bipolar disorder
Exclusivity Code: I - New IndicationMAR 01,2008I-488: Maintenance therapy in bipolar I disorder
Exclusivity Code: NCE - New chemical entityNOV 15,2007 

ABILIFY (SOLUTION) ARIPIPRAZOLE
NDA Applicant: OTSUKA      NDA No.: 021713  Prod. No.: 001 RX (1MG/ML)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationAUG 28,2006I-401: Longer-term efficacy of aripiprazole in the treatment of schizophrenia
Exclusivity Code: I - New IndicationSEP 29,2007I-437: Treatment of acute manic and mixed episodes associated with bipolar disorder
Exclusivity Code: I - New IndicationMAR 01,2008I-488: Maintenance therapy in bipolar I disorder
Exclusivity Code: NCE - New chemical entityNOV 15,2007 

ABRAXANE (FOR SUSPENSION) PACLITAXEL
NDA Applicant: ABRAXIS BIOSCIENCE      NDA No.:
021660  Prod. No.: 001 RX (100MG/VIAL)
PatentsExpirationPatented 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 12,2013U-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 22,2013U-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 22,2013U-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 22,2013U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJAN 07,2008 

ABREVA (CREAM) DOCOSANOL
NDA Applicant: GLAXOSMITHKLINE      NDA No.:
020941  Prod. No.: 001 OTC (10%)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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 18,2014U-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)
PatentsExpirationPatented Use
Pat. No. 6702997 Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma
Claim Types: Method of use
DEC 28,2021U-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)
PatentsExpirationPatented 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 *PEDU-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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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 10,2009U-531: Treatment of patients with essential hypertension. May be used alone or given with other classes of antihypertensives, especially thiazide derivatives
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationAUG 23,2008I-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))
ExclusivityExpirationExclusivity Description
Exclusivity Code ODE: Orphan DrugJAN 23,2011For 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**)
PatentsExpirationPatented Use
Pat. No. 5035899 Peroral preparation of acid-unstable compound
Claim Types: Formulation
APR 04,2009U-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 08,2013U-385: Treatment of peptic ulcers

ACTINEX (CREAM) MASOPROCOL
NDA Applicant: UNIV AZ CANCER CTR      NDA No.:
019940  Prod. No.: 001 DISC (10%)
PatentsExpirationPatented 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 15,2008U-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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented Use
Pat. No. 5583122 Pharmaceutical compositions containing geminal diphosphonates
Claim Types: Compound; Composition; Method of use
DEC 10,2013U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJAN 24,2009M-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)
PatentsExpirationPatented Use
Pat. No. 5583122 DS* DP* Pharmaceutical compositions containing geminal diphosphonates
Claim Types: Compound; Composition; Method of use
DEC 10,2013U-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 10,2013U-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 17,2018U-353: Prevention and treatment of osteoporosis
Pat. No. 6015801 Method for inhibiting bone resorption
Claim Types: Method of use
JUL 17,2018U-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 17,2018U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationAUG 11,2009I-309: Use of ACTONEL 35mg once a week to increase bone mass in men with osteoporosis
Exclusivity Code: M - MiscellaneousJAN 24,2009M-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)
PatentsExpirationPatented Use
Pat. No. 5583122 DS* DP* Pharmaceutical compositions containing geminal diphosphonates
Claim Types: Compound; Composition; Method of use
DEC 10,2013U-353: Prevention and treatment of osteoporosis
Pat. No. 5994329 Method for inhibiting bone resorption
Claim Types: Method of use; Kit
JUL 17,2018U-353: Prevention and treatment of osteoporosis
Pat. No. 6015801 Method for inhibiting bone resorption
Claim Types: Method of use
JUL 17,2018U-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 17,2018U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJAN 24,2009M-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)
PatentsExpirationPatented 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 19,2016U-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 19,2016U-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 19,2016U-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 19,2016U-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)
PatentsExpirationPatented 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 19,2016U-417: Combination use of AD-4833 with a biguanide
Pat. No. 6150383 Pharmaceutical composition
Claim Types: Method of use
JUN 19,2016U-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 19,2016U-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 19,2016U-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 19,2016U-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 19,2016U-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 19,2016U-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 19,2016U-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 09,2016U-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 19,2016U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousNOV 26,2006M-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%)
PatentsExpirationPatented Use
Pat. No. 5110493 Ophthalmic NSAID formulations containing a quaternary ammonium preservative and a nonionic surfactant
Claim Types: Formulation; Excipient
NOV 05,2009 *PEDU-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%)
PatentsExpirationPatented Use
Pat. No. 5110493 Ophthalmic NSAID formulations containing a quaternary ammonium preservative and a nonionic surfactant
Claim Types: Formulation; Excipient
NOV 05,2009 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMAY 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)
PatentsExpirationPatented 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%)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NDF - New dosage formJUL 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationAUG 11,2007 
Exclusivity Code: NPP - New patient populationJan 21,2009 PED 

ADENOSCAN (INJECTABLE) ADENOSINE [Has competitive generic]
Drug Classes: ANTIARRHYTHMICS
NDA Applicant: ASTELLAS      NDA No.:
020059  Prod. No.: 001 RX (3MG/ML)
PatentsExpirationPatented Use
Pat. No. 5070877 [Extended 159 days* (0.4 years)]
Novel method of myocardial imaging
Claim Types: Diagnostic or surgical method
MAY 18,2009U-116: Method of myocardial imaging
Pat. No. 5731296 Selective vasodilation by continuous adenosine infusion
Claim Types: Method of use
MAR 24,2015U-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)
PatentsExpirationPatented Use
Pat. No. 4992474 Phenethanolamine derivatives
Claim Types: Compound; Composition; Method of use
AUG 12,2008 *PEDU-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 *PEDU-211: Use in patients with reversible airway obstruction
Pat. No. 5270305 Medicaments
Claim Types: Composition; Method of use
SEP 07,2010U-387: Treatment of patients with respiratory disorders
Pat. No. 6536427 DP* Inhalation device
Claim Types: Device
SEP 01,2011 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousAPR 21,2007M-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)
PatentsExpirationPatented Use
Pat. No. 4992474 Phenethanolamine derivatives
Claim Types: Compound; Composition; Method of use
AUG 12,2008 *PEDU-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 *PEDU-211: Use in patients with reversible airway obstruction
Pat. No. 5270305 Medicaments
Claim Types: Composition; Method of use
SEP 07,2010U-387: Treatment of patients with respiratory disorders
Pat. No. 6536427 DP* Inhalation device
Claim Types: Device
SEP 01,2011 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationNOV 17,2006I-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)
PatentsExpirationPatented Use
Pat. No. 4992474 Phenethanolamine derivatives
Claim Types: Compound; Composition; Method of use
AUG 12,2008 *PEDU-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 *PEDU-211: Use in patients with reversible airway obstruction
Pat. No. 5270305 Medicaments
Claim Types: Composition; Method of use
SEP 07,2010U-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)
PatentsExpirationPatented Use
Pat. No. 4992474 DS* DP* Phenethanolamine derivatives
Claim Types: Compound; Composition; Method of use
AUG 12,2008 *PEDU-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 *PEDU-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 07,2010U-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 19,2014U-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 14,2015U-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 14,2015U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJUN 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)
PatentsExpirationPatented Use
Pat. No. 6080428 Nicotinic acid compositions for treating hyperlipidemia and related methods therefor
Claim Types: Method of use
MAY 27,2017U-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 20,2013U-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 31,2017U-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 20,2013U-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 20,2013U-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 20,2013U-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)
PatentsExpirationPatented Use
Pat. No. 6080428 Nicotinic acid compositions for treating hyperlipidemia and related methods therefor
Claim Types: Method of use
MAY 27,2017U-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 20,2013U-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 31,2017U-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 20,2013U-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 20,2013U-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 20,2013U-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)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productFEB 24,2007 

ADVIL COLD AND SINUS (CAPSULE) IBUPROFEN POTASSIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
NDA Applicant: WYETH CONS      NDA No.:
021374  Prod. No.: 001 OTC (200MG;30MG)
PatentsExpirationPatented 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)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NC - New combinationDEC 21,2008 

ADVIL PM (TABLET) DIPHENHYDRAMINE CITRATE; IBUPROFEN
NDA Applicant: WYETH CONS      NDA No.: 021394  Prod. No.: 001 OTC (38MG;200MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NC - New combinationDEC 21,2008 

ADVIL, CHILDREN'S (SUSPENSION) IBUPROFEN [Has competitive generic]
NDA Applicant: WYETH CONS      NDA No.:
019833  Prod. No.: 002 RX (100MG/5ML)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJAN 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)
PatentsExpirationPatented 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 08,2014U-257: Treatment of HIV infection
Pat. No. 5723490 THF-containing sulfonamide inhibitors of aspartyl protease
Claim Types: Composition; Method of use
MAR 03,2015U-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)
PatentsExpirationPatented 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 08,2014U-257: Treatment of HIV infection
Pat. No. 5723490 THF-containing sulfonamide inhibitors of aspartyl protease
Claim Types: Composition; Method of use
MAR 03,2015U-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)
PatentsExpirationPatented Use
Pat. No. 5292756 [Extended 433 days* (1.2 years)]
Novel sulfonamide fibrinogen receptor antagonists
Claim Types: Compound; Method of use
MAY 14,2012U-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 27,2010U-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)
PatentsExpirationPatented Use
Pat. No. 5292756 [Extended 433 days* (1.2 years)]
Novel sulfonamide fibrinogen receptor antagonists
Claim Types: Compound; Method of use
MAY 14,2012U-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 27,2010U-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)
PatentsExpirationPatented 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 18,2017U-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)
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJun 10,2008 PEDM-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%)
PatentsExpirationPatented Use
Pat. No. 5034230 Anti-allergic ophthalmics
Claim Types: Formulation; Method of use
JUN 23,2009 *PEDU-184: Treating allergic eye diseases in humans

ALDARA (CREAM) IMIQUIMOD
Drug Classes: DERMATOLOGICS
NDA Applicant: 3M      NDA No.:
020723  Prod. No.: 001 RX (5%)
PatentsExpirationPatented 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 25,2009U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMAR 02,2007I-420: Topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults
Exclusivity Code: I - New IndicationJUL 14,2007I-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)
PatentsExpirationPatented 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 29,2011U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityFEB 04,2009 
Exclusivity Code ODE: Orphan DrugFEB 04,2011Treatment of malignant pleural mesothelioma

ALINIA (TABLET) NITAZOXANIDE
Drug Classes: ANTIPROTOZOALS; ANTHELMINTICS
NDA Applicant: ROMARK      NDA No.:
021497  Prod. No.: 001 RX (500MG)
PatentsExpirationPatented Use
Pat. No. 5387598 DP* Composition and galenic formulation suitable for combatting affections of the lower abdomen
Claim Types: Formulation; Method of use
FEB 07,2012U-524: Method of treating diarrhea
Pat. No. 5578621 DP* Benzamide derivatives
Claim Types: Composition; Method of use; Method of improving a treatment
NOV 26,2013U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJUN 16,2008I-460: Treatment of diarrhea caused by cryptosporidium parvum in non-HIV infected patients 12 years of age and older
Exclusivity Code: NCE - New chemical entityNOV 22,2007 
Exclusivity Code: NDF - New dosage formJUL 21,2007 
Exclusivity Code ODE: Orphan DrugNOV 22,2009Treatment of cryptosporidiosis.
Exclusivity Code ODE: Orphan DrugNOV 22,2009Treatment of intestinal giardiasis.

ALINIA (FOR SUSPENSION) NITAZOXANIDE
Drug Classes: ANTIPROTOZOALS; ANTHELMINTICS
NDA Applicant: ROMARK      NDA No.: 021498  Prod. No.: 001 RX (100MG/5ML)
PatentsExpirationPatented Use
Pat. No. 5387598 Composition and galenic formulation suitable for combatting affections of the lower abdomen
Claim Types: Formulation; Method of use
FEB 07,2012U-524: Method of treating diarrhea
Pat. No. 5578621 Benzamide derivatives
Claim Types: Composition; Method of use; Method of improving a treatment
SEP 08,2014U-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 03,2017U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJUN 16,2008I-460: Treatment of diarrhea caused by cryptosporidium parvum in non-HIV infected patients 12 years of age and older
Exclusivity Code: NCE - New chemical entityNOV 22,2007 
Exclusivity Code: NPP - New patient populationJUL 21,2007 
Exclusivity Code ODE: Orphan DrugNOV 22,2009Treatment of cryptosporidiosis.
Exclusivity Code ODE: Orphan DrugNOV 22,2009Treatment 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented Use
Pat. No. 5578610 Piperidine derivatives
Claim Types: Composition; Method of use
MAY 26,2014 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-468: Method of using fexofenadine HCl in treating allergic rhinitis
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousNov 12,2006 PEDM-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)
PatentsExpirationPatented Use
Pat. No. 5578610 DS* DP* Piperidine derivatives
Claim Types: Composition; Method of use
MAY 26,2014 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-468: Method of using fexofenadine HCl in treating allergic rhinitis
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousNov 12,2006 PEDM-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)
PatentsExpirationPatented Use
Pat. No. 5578610 DS* DP* Piperidine derivatives
Claim Types: Composition; Method of use
MAY 26,2014 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-468: Method of using fexofenadine HCl in treating allergic rhinitis
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleOCT 13,2008D-101: Once daily in chronic idiopathic uticaria for adults and children 12 years of age and older
Exclusivity Code: M - MiscellaneousNov 12,2006 PEDM-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)
PatentsExpirationPatented Use
Pat. No. 5578610 DS* DP* Piperidine derivatives
Claim Types: Composition; Method of use
MAY 26,2014 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 25,2020U-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)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-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%)
PatentsExpirationPatented 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 02,2006U-304: A method of treatment of a condition involving an antibody antigen reaction
Pat. No. RE38628 Pharmaceutical compositions
Claim Types: Method of use
AUG 22,2012U-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)
PatentsExpirationPatented Use
Pat. No. 5457126 Use of lodoxamide to treat ophthalmic allergic conditions
Claim Types: Method of use
OCT 10,2012U-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)
PatentsExpirationPatented 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)
PatentsExpirationPatented Use
Pat. No. 5202333 Tricyclic 5-HT.sub.3 receptor antagonists
Claim Types: Compound; Composition; Method of use
APR 13,2010U-528: Prevention of chemotherapy-induced nausea and vomiting
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJUL 25,2008 

ALPHAGAN P (SOLUTION/DROPS) BRIMONIDINE TARTRATE
Drug Classes: GLAUCOMA
NDA Applicant: ALLERGAN      NDA No.:
021262  Prod. No.: 001 RX (0.15%)
PatentsExpirationPatented 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%)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productAUG 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%)
PatentsExpirationPatented 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 25,2013U-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)
PatentsExpirationPatented 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 04,2012U-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)
PatentsExpirationPatented 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 23,2018U-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)
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMay 28,2009 PEDM-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)
PatentsExpirationPatented 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 21,2006U-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)
PatentsExpirationPatented 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 21,2006U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NDF - New dosage formSEP 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)
PatentsExpirationPatented Use
Pat. No. 4997841 [Extended 694 days (1.9 years)]
Indole derivatives
Claim Types: Compound; Composition; Method of use
JUL 07,2010U-232: Method of treating migraine

AMITIZA (CAPSULE) LUBIPROSTONE
NDA Applicant: SUCAMPO PHARMS      NDA No.:
021908  Prod. No.: 001 RX (24UGM)
PatentsExpirationPatented 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 31,2011U-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 05,2020U-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 30,2022U-739: Method for treating constipation by opening CIC channels in a mammalian subject
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJAN 31,2011 

AMLEXANOX (PATCH) AMLEXANOX
NDA Applicant: ULURU      NDA No.:
021727  Prod. No.: 001 RX (2MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NDF - New dosage formSEP 29,2007 

AMMONUL (SOLUTION) SODIUM BENZOATE; SODIUM PHENYLACETATE
NDA Applicant: UCYCLYD      NDA No.:
020645  Prod. No.: 001 RX (10%;10% (5GM/50ML;5GM/50ML))
ExclusivityExpirationExclusivity Description
Exclusivity Code: NDF - New dosage formFEB 17,2008 
Exclusivity Code ODE: Orphan DrugFEB 17,2012For 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)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOCT 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)
PatentsExpirationPatented 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 11,2010U-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%)
PatentsExpirationPatented Use
Pat. No. 6503894 Pharmaceutical composition and method for treating hypogonadism
Claim Types: Formulation; Device; Method of administration
AUG 30,2020U-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)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productSEP 28,2008 

ANGIOMAX (INJECTABLE) BIVALIRUDIN
NDA Applicant: MEDICINES CO      NDA No.:
020873  Prod. No.: 001 RX (250MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 5196404 Inhibitors of thrombin
Claim Types: Compound; Composition; Method of use; Method of improving a treatment
MAR 23,2010 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJUN 13,2008I-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 IndicationNOV 30,2008I-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)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousOCT 21,2008M-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)
PatentsExpirationPatented 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%)
PatentsExpirationPatented 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 16,2007U-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 24,2013U-752: Sunscreen
ExclusivityExpirationExclusivity Description
Exclusivity Code: NC - New combinationJUL 21,2009 

ANTIZOL (INJECTABLE) FOMEPIZOLE
Drug Classes: ANTIDOTES, SPECIFIC
NDA Applicant: JAZZ      NDA No.:
020696  Prod. No.: 001 RX (1GM/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Code ODE: Orphan DrugDEC 08,2007Treatment 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)
PatentsExpirationPatented 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))
PatentsExpirationPatented 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%)
PatentsExpirationPatented Use
Pat. No. 5362737 Methods of treating aphthous ulcers and other mucocutaneous disorders with amlexanox
Claim Types: Method of use
NOV 08,2011U-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))
PatentsExpirationPatented Use
Pat. No. 6221633 DS* DP* Insulin derivatives having a rapid onset of action
Claim Types: Compound; Process; Composition; Intermediate
JUN 18,2018U-471: Method of treating a patient suffering from diabetes mellitus
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityAPR 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))
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityAPR 20,2009 
Exclusivity Code ODE: Orphan DrugAPR 20,2011Treatment 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)
PatentsExpirationPatented 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 29,2019U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJUN 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)
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationDec 13,2006 PEDI-395: To improve physical function
Exclusivity Code: M - MiscellaneousSep 05,2007 PEDM-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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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 25,2010U-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)
PatentsExpirationPatented 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)
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJUN 17,2006I-397: Extended prophylaxis in patients undergoing hip fracture surgery
Exclusivity Code: I - New IndicationMAY 31,2007I-426: Treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium
Exclusivity Code: I - New IndicationMAY 31,2007I-427: Treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium
Exclusivity Code: I - New IndicationMAY 26,2008I-457: Treatment of patients undergoing abdominal surgery who are at risk for thromboembolic complications
Exclusivity Code: NCE - New chemical entityDEC 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)
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJUN 17,2006I-397: Extended prophylaxis in patients undergoing hip fracture surgery
Exclusivity Code: I - New IndicationMAY 31,2007I-426: Treatment of acute pulmonary embolism when administered in conjunction with warfarin sodium
Exclusivity Code: I - New IndicationMAY 31,2007I-427: Treatment of acute deep vein thrombosis without pulmonary embolism when administered in conjunction with warfarin sodium
Exclusivity Code: I - New IndicationMAY 26,2008I-457: Treatment of patients undergoing abdominal surgery who are at risk for thromboembolic complications
Exclusivity Code: NCE - New chemical entityDEC 07,2006 
Exclusivity Code: NS - New strengthMAY 31,2007 

AROMASIN (TABLET) EXEMESTANE
Drug Classes: HORMONAL/BIOLOGICAL RESPONSE MODIFIERS
NDA Applicant: PHARMACIA AND UPJOHN      NDA No.:
020753  Prod. No.: 001 RX (25MG)
PatentsExpirationPatented 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 01,2011U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationOCT 05,2008I-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 DrugOCT 21,2006Treatment 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))
PatentsExpirationPatented 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 20,2013U-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 20,2013U-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 20,2013U-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 20,2013U-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 20,2013U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityOCT 28,2010 
Exclusivity Code ODE: Orphan DrugOCT 28,2012Treatment 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)
PatentsExpirationPatented 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 03,2010U-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)
PatentsExpirationPatented Use
Pat. No. 5541170 Orally administrable pharmaceutical compositions
Claim Types: Formulation
JUL 30,2013U-141: Treatment of ulcerative colitis
Pat. No. 5541171 Orally administrable pharmaceutical composition
Claim Types: Formulation; Method of use
JUL 30,2013U-141: Treatment of ulcerative colitis

ASMANEX TWISTHALER (POWDER) MOMETASONE FUROATE
NDA Applicant: SCHERING      NDA No.:
021067  Prod. No.: 001 RX (0.22MG/INH)
PatentsExpirationPatented 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 27,2014U-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 27,2014U-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 27,2014U-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 27,2014U-645: Treatment of asthma
Pat. No. 6949532 Use of mometasone furoate for treating airway passage and lung diseases
Claim Types: Method of use
JAN 27,2014U-645: Treatment of asthma
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMAR 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)
PatentsExpirationPatented Use
Pat. No. 5164194 [Extended 349 days* (1 years)]
Azelastine containing medicaments
Claim Types: Method of use
MAY 01,2011 *PEDU-207: Use as nasal spray
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleFEB 17,2009D-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)
PatentsExpirationPatented 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 04,2012U-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 04,2012U-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 18,2011U-660: Treatment of hypertension and treatment of heart failure
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationFEB 22,2008I-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 IndicationMAY 18,2008I-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 IndicationMAY 18,2008I-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)
PatentsExpirationPatented 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 04,2012U-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 18,2011U-3: Treatment of hypertension
Pat. No. 5705517 Benzimidazole derivatives and use thereof
Claim Types: Compound; Composition; Method of use
APR 18,2011U-3: Treatment of hypertension
Pat. No. 5721263 Pharmaceutical composition for angiotensin II-mediated diseases
Claim Types: Composition; Method of use
FEB 24,2015U-3: Treatment of hypertension
Pat. No. 5958961 Pharmaceutical composition for angiotensin II-mediated diseases
Claim Types: Composition; Method of use
JUN 06,2014U-3: Treatment of hypertension

ATRIPLA (TABLET) EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
NDA Applicant: GILEAD      NDA No.:
021937  Prod. No.: 001 RX (600MG;200MG;300MG)
PatentsExpirationPatented 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 *PEDU-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 02,2014U-750: Treatment of hiv-1 infection in adults
Pat. No. 5811423 Benzoxazinones as inhibitors of HIV reverse transcriptase
Claim Types: Method of use
AUG 07,2012U-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 25,2017U-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 25,2017U-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 25,2017U-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 25,2017U-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 06,2019U-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 *PEDU-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)
PatentsExpirationPatented 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 06,2010U-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 28,2009U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productNOV 17,2007 

AVAGARD (SOLUTION) ALCOHOL; CHLORHEXIDINE GLUCONATE
NDA Applicant: 3M      NDA No.:
021074  Prod. No.: 001 OTC (61%;1%)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented Use
Pat. No. 5002953 DS* DP* [Extended 1113 days (3 years)]
Novel compounds
Claim Types: Compound; Composition; Method of use
MAR 17,2012 *PEDU-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 *PEDU-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 5965584 Pharmaceutical composition
Claim Types: Composition; Method of use
JUN 19,2016U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 6166042 Pharmaceutical composition
Claim Types: Method of use
JUN 19,2016U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 6288095 Compounds
Claim Types: Composition; Method of use; Process
AUG 11,2017 *PEDU-493: Treatment of Type 2 Diabetes Mellitus
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMAY 19,2009I-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)
PatentsExpirationPatented Use
Pat. No. 5002953 DS* DP* [Extended 1113 days (3 years)]
Novel compounds
Claim Types: Compound; Composition; Method of use
MAR 17,2012 *PEDU-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 5741803 DS* DP* Substituted thiazolidinedionle derivatives
Claim Types: Compound; Method of use
OCT 21,2015 *PEDU-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 5965584 Pharmaceutical composition
Claim Types: Composition; Method of use
JUN 19,2016U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 6166042 Pharmaceutical composition
Claim Types: Method of use
JUN 19,2016U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 6288095 Compounds
Claim Types: Composition; Method of use; Process
AUG 11,2017 *PEDU-493: Treatment of Type 2 Diabetes Mellitus
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMAY 19,2009I-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)
PatentsExpirationPatented Use
Pat. No. 5002953 DS* DP* [Extended 1113 days (3 years)]
Novel compounds
Claim Types: Compound; Composition; Method of use
MAR 17,2012 *PEDU-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 *PEDU-734: First line therapy for type 2 diabetes mellitus
Pat. No. 5965584 Pharmaceutical composition
Claim Types: Composition; Method of use
JUN 19,2016U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 6166042 Pharmaceutical composition
Claim Types: Method of use
JUN 19,2016U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 6288095 Compounds
Claim Types: Composition; Method of use; Process
AUG 11,2017 *PEDU-493: Treatment of Type 2 Diabetes Mellitus
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMAY 19,2009I-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)
PatentsExpirationPatented Use
Pat. No. 5002953 DS* DP* [Extended 1113 days (3 years)]
Novel compounds
Claim Types: Compound; Composition; Method of use
MAR 17,2012 *PEDU-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 *PEDU-493: Treatment of Type 2 Diabetes Mellitus
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMAY 19,2009I-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)
PatentsExpirationPatented Use
Pat. No. 5002953 DS* DP* [Extended 1113 days (3 years)]
Novel compounds
Claim Types: Compound; Composition; Method of use
MAR 17,2012 *PEDU-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 *PEDU-734: First line therapy for type 2 diabetes mellitus
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMAY 19,2009I-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)
PatentsExpirationPatented Use
Pat. No. 5002953 DS* DP* [Extended 1113 days (3 years)]
Novel compounds
Claim Types: Compound; Composition; Method of use
MAR 17,2012 *PEDU-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 *PEDU-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)
PatentsExpirationPatented Use
Pat. No. 5002953 DS* DP* [Extended 1113 days (3 years)]
Novel compounds
Claim Types: Compound; Composition; Method of use
MAR 17,2012 *PEDU-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 *PEDU-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 *PEDU-420: Method of treatment of Type II diabetes
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationAug 27,2006 PEDI-384: Use in combination with insulin for the treatment of patients with Type 2 diabetes mellitus
Exclusivity Code: I - New IndicationFEB 28,2008I-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)
PatentsExpirationPatented Use
Pat. No. 5002953 DS* DP* [Extended 1113 days (3 years)]
Novel compounds
Claim Types: Compound; Composition; Method of use
MAR 17,2012 *PEDU-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 *PEDU-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 *PEDU-420: Method of treatment of Type II diabetes
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationAug 27,2006 PEDI-384: Use in combination with insulin for the treatment of patients with Type 2 diabetes mellitus
Exclusivity Code: I - New IndicationFEB 28,2008I-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)
PatentsExpirationPatented Use
Pat. No. 5002953 DS* DP* [Extended 1113 days (3 years)]
Novel compounds
Claim Types: Compound; Composition; Method of use
MAR 17,2012 *PEDU-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 *PEDU-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 *PEDU-420: Method of treatment of Type II diabetes
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationAug 27,2006 PEDI-384: Use in combination with insulin for the treatment of patients with Type 2 diabetes mellitus
Exclusivity Code: I - New IndicationFEB 28,2008I-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)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMar 17,2006 PEDI-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)
PatentsExpirationPatented 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 08,2011U-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 04,2014U-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 05,2016U-298: Method of combating bacteria in a patient
Pat. No. 6610327 DP* Pharmaceutical moxifloxacin preparation
Claim Types: Formulation; Process; Method of use
OCT 29,2019U-298: Method of combating bacteria in a patient
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationFEB 28,2006I-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 IndicationJUN 13,2008I-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 IndicationNOV 18,2008I-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)
PatentsExpirationPatented 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 08,2011U-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 04,2014U-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 05,2016U-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 25,2020U-298: Method of combating bacteria in a patient
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationFEB 28,2006I-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 IndicationJUN 13,2008I-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 IndicationNOV 18,2008I-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)
PatentsExpirationPatented 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%)
PatentsExpirationPatented Use
Pat. No. 4971800 Method and compositions for enhancing the cutaneous penetration of pharmacologically active agents
Claim Types: Excipient; Method of administration
NOV 20,2007U-178: Facilitated adherence of agents to skin
Pat. No. 5045317 Enhancing the cutaneous penetration of pharmacologically active agents
Claim Types: Formulation
SEP 03,2008U-179: Enhanced cutaneous penetration of a dermally-applied pharmacologically active agent
ExclusivityExpirationExclusivity Description
Exclusivity Code ODE: Orphan DrugJUN 04,2008 

AVODART (CAPSULE) DUTASTERIDE
NDA Applicant: GLAXOSMITHKLINE      NDA No.:
021319  Prod. No.: 001 RX (0.5MG)
PatentsExpirationPatented Use
Pat. No. 5565467 Androstenone derivative
Claim Types: Compound; Composition
OCT 15,2013 
Pat. No. 5846976 Androstenone derivative
Claim Types: Method of use
SEP 17,2013U-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 17,2013U-477: Method of inhibiting 5-alpha testosterone reductase enzyme with dutasteride or its derivative and treating androgen responsive/mediated disease including benign prostatic hyperplasia
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityNOV 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)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMAY 07,2006 

AXID (SOLUTION) NIZATIDINE
NDA Applicant: BRAINTREE      NDA No.:
021494  Prod. No.: 001 RX (15MG/ML)
PatentsExpirationPatented Use
Pat. No. 6930119 DP* Liquid pharmaceutical composition
Claim Types: Formulation
JUL 17,2022 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NDF - New dosage formMAY 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)
PatentsExpirationPatented 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 07,2012U-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 07,2012U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMAY 16,2011 

AZOPT (SUSPENSION/DROPS) BRINZOLAMIDE
Drug Classes: GLAUCOMA
NDA Applicant: ALCON      NDA No.:
020816  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 5240923 Sulfonamides useful as carbonic anhydrase inhibitors
Claim Types: Compound; Formulation; Method of use
MAR 01,2011 *PEDU-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 *PEDU-224: Controlling intraocular pressure
Pat. No. 5461081 Topical ophthalmic pharmaceutical vehicles
Claim Types: Excipient; Method of administration
APR 24,2013 *PEDU-225: Method for delivery


DS*=Drug Substance; DP*=Drug Product - patent submitted for the product after Aug. 18, 2003.
* Extension limited by the 14-year cap of 35 USC 156(c)(3)
Last edited: 26 September 2006
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