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 do