ACE INHIBITORS
ACCURETIC (TABLET) HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANTIHYPERTENSIVES; DIURETICS; ACE INHIBITORS
NDA Applicant: PFIZER PHARMS      NDA No.: 020125  Prod. No.: 001 RX (12.5MG;EQ 10MG BASE); 002 RX (12.5MG;EQ 20MG BASE); 003 RX (25MG;EQ 20MG BASE)

Patents	Expiration	Patented Use
Pat. No. 4743450 Stabilized compositions Claim Types: Formulation; Process	AUG 24,2007 *PED

ACE INHIBITORS
ACEON (TABLET) PERINDOPRIL ERBUMINE
Drug Classes: ACE INHIBITORS
NDA Applicant: SOLVAY PHARMS      NDA No.: 020184  Prod. No.: 001 RX (2MG); 002 RX (4MG); 003 RX (8MG)

Patents	Expiration	Patented Use
Pat. No. 4508729 [Extended 1601 days (4.4 years)] Substituted iminodiacids, their preparation and pharmaceutical compositions containing them Claim Types: Compound; Composition; Method of use	AUG 21,2006
Pat. No. 5162362 DS* DP* Octahydroindole-2-carboxylic acids Claim Types: Compound; Composition; Method of use	NOV 10,2009	U-531: Treatment of patients with essential hypertension. May be used alone or given with other classes of antihypertensives, especially thiazide derivatives
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	AUG 23,2008	I-468: Use in patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or non-fatal myocardial infection

ACE INHIBITORS
ALTACE (CAPSULE) RAMIPRIL [GENERIC AB]
Drug Classes: ACE INHIBITORS; ANTIHYPERTENSIVES
NDA Applicant: KING PHARMS      NDA No.: 019901  Prod. No.: 001 RX (1.25MG); 002 RX (2.5MG); 003 RX (5MG); 004 RX (10MG)

Patents	Expiration	Patented Use
Pat. No. 5061722 Cis, endo-2-azabicyclo-[3.3.0]-octane-3-carboxylic acids, a process for their preparation, agents containing these compounds and their use Claim Types: Compound; Composition; Method of use	OCT 19,2008
Pat. No. 5403856 Method of treating cardiac insufficiency using angiotensin-converting enzyme inhibitors Claim Types: Method of use	APR 04,2012	U-71: Method of treatment of heart failure

ACE INHIBITORS
CAPOTEN (TABLET) CAPTOPRIL [GENERIC AB]
Drug Classes: ANTIHYPERTENSIVES; ACE INHIBITORS
NDA Applicant: PAR PHARM      NDA No.: 018343  Prod. No.: 001 RX (50MG); 002 RX (25MG); 003 RX (100MG); 005 RX (12.5MG) NDA No.: 018343  Prod. No.: 004 DISC (150MG); 006 DISC (37.5MG); 007 DISC (75MG)

Patents	Expiration	Patented Use
Pat. No. 5238924 Treatment of renal diseases with ace inhibitors Claim Types: Method of use	AUG 24,2010	U-92: Treatment of diabetic nephropathy in patients with Type I insulin dependent diabetes mellitus and retinopathy

ACE INHIBITORS
COZAAR (TABLET) LOSARTAN POTASSIUM
Drug Classes: ACE INHIBITORS; ANTIHYPERTENSIVES
NDA Applicant: MERCK      NDA No.: 020386  Prod. No.: 001 RX (25MG); 002 RX (50MG); 003 RX (100MG)

Patents	Expiration	Patented Use
Pat. No. 5138069 Angiotensin II receptor blocking imidazoles Claim Types: Compound	FEB 11,2010 *PED
Pat. No. 5153197 Treatment of hypertension with angiotensin II blocking imidazoles Claim Types: Composition; Method of use	APR 06,2010 *PED	U-3: Treatment of hypertension
Pat. No. 5210079 Treatment of chronic renal failure with imidazole angiotensin-II receptor antagonists Claim Types: Method of use	NOV 11,2010 *PED	U-496: Method for treating chronic renal failure
Pat. No. 5608075 Polymorphs of losartan and the process for the preparation of form II of losartan Claim Types: New polymorph, salt or hydrate; Composition; Process	SEP 04,2014 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NPP - New patient population	Sep 11,2007 PED

ACE INHIBITORS
DIOVAN HCT (TABLET) HYDROCHLOROTHIAZIDE; VALSARTAN
Drug Classes: DIURETICS; ACE INHIBITORS; ANTIHYPERTENSIVES
NDA Applicant: NOVARTIS      NDA No.: 020818  Prod. No.: 001 RX (12.5MG;80MG); 002 RX (12.5MG;160MG); 003 RX (25MG;160MG)

Patents	Expiration	Patented Use
Pat. No. 5399578 Acyl compounds Claim Types: Compound; Composition; Method of use	MAR 21,2012	U-3: Treatment of hypertension
Pat. No. 6294197 Solid oral dosage forms of valsartan Claim Types: Formulation; Method of use; Process	JUN 18,2017	U-3: Treatment of hypertension

ACE INHIBITORS
DIOVAN HCT (TABLET) HYDROCHLOROTHIAZIDE; VALSARTAN
Drug Classes: DIURETICS; ACE INHIBITORS; ANTIHYPERTENSIVES
NDA Applicant: NOVARTIS      NDA No.: 020818  Prod. No.: 004 RX (12.5MG;320MG); 005 RX (25MG;320MG)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NS - New strength	APR 28,2009

ACE INHIBITORS
DIOVAN (CAPSULE) VALSARTAN
Drug Classes: ACE INHIBITORS
NDA Applicant: NOVARTIS      NDA No.: 020665  Prod. No.: 001 DISC (80MG); 002 DISC (160MG)

Patents	Expiration	Patented Use
Pat. No. 5399578 Acyl compounds Claim Types: Compound; Composition; Method of use	MAR 21,2012	U-3: Treatment of hypertension

ACE INHIBITORS
EPZICOM (TABLET) ABACAVIR SULFATE; LAMIVUDINE
Drug Classes: ACE INHIBITORS
NDA Applicant: SMITHKLINE BEECHAM      NDA No.: 021652  Prod. No.: 001 RX (EQ 600MG BASE;300MG)

Patents	Expiration	Patented Use
Pat. No. 5034394 DS* DP* [Extended 905 days (2.5 years)] Therapeutic nucleosides Claim Types: Compound; Composition Comments: For its TRIZIVIR listing, the expiration date of this patent does not include the extension	JUN 18,2012 *PED
Pat. No. 5047407 DS* DP* [Extended 282 days* (0.8 years)] 2-substituted-5-substituted-1,3-oxathiolanes with antiviral properties Claim Types: Compound; Composition	MAY 17,2010 *PED	U-257: Treatment of HIV infection
Pat. No. 5089500 Therapeutic nucleosides Claim Types: Method of use	DEC 26,2009 *PED	U-257: Treatment of HIV infection
Pat. No. 5905082 DS* DP* Crystalline oxathiolane derivatives Claim Types: Composition; Method of use	NOV 18,2016 *PED
Pat. No. 6294540 DS* DP* Carbocyclic nucleoside hemisulfate and its use in treating viral infections Claim Types: Composition; Method of use	NOV 14,2018 *PED	U-257: Treatment of HIV infection
Pat. No. 6417191 DP* Synergistic combinations of zidovudine, 1592U89 and 3TC Claim Types: Method of use; Composition; Formulation	MAR 28,2016	U-257: Treatment of HIV infection
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: D - New Dosing Schedule	AUG 02,2007	D-40: Once-a-day dosing regimen

ACE INHIBITORS
LEXXEL (TABLET, EXTENDED RELEASE) ENALAPRIL MALEATE; FELODIPINE
Drug Classes: CALCIUM CHANNEL BLOCKERS; ACE INHIBITORS
NDA Applicant: ASTRAZENECA      NDA No.: 020668  Prod. No.: 001 RX (5MG;5MG); 002 RX (5MG;2.5MG)

Patents	Expiration	Patented Use
Pat. No. 4803081 New pharmaceutical preparations with extended release Claim Types: Formulation; Process	OCT 03,2007 *PED

ACE INHIBITORS
LOTENSIN (TABLET) BENAZEPRIL HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANTIHYPERTENSIVES; ACE INHIBITORS; HYPOTENSION/SHOCK
NDA Applicant: NOVARTIS      NDA No.: 019851  Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (20MG); 004 RX (40MG)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	Sep 02,2007 PED	M-30: Changes to clinical pharmacology, precautions, and dosage and administration sections of labeling concerning use of LOTENSIN in pediatric patients with hypertension

ACE INHIBITORS
LOTREL (CAPSULE) AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Drug Classes: CALCIUM CHANNEL BLOCKERS; ACE INHIBITORS; ANTIHYPERTENSIVES
NDA Applicant: NOVARTIS      NDA No.: 020364  Prod. No.: 002 RX (EQ 2.5MG BASE;10MG); 003 RX (EQ 5MG BASE;10MG); 004 RX (EQ 5MG BASE;20MG); 005 RX (EQ 10MG BASE;20MG)

Patents	Expiration	Patented Use
Pat. No. 4572909 [Extended 1252 days (3.4 years)] 2-(Secondary aminoalkoxymethyl) dihydropyridine derivatives as anti-ischaemic and antihypertensive agents Claim Types: Compound; Composition; Method of use Comments: Amlodipine and its salts, generally.	JUL 31,2006
Pat. No. 4879303 Pharmaceutically acceptable salts Claim Types: Compound;Composition; Formulation	MAR 25,2007
Pat. No. 6162802 Synergistic combination therapy using benazepril and amlodipine for the treatment of cardiovascular disorders and compositions therefor Claim Types: Method of use; Formulation	DEC 19,2017	U-367: Treatment of cardiovascular disorders

ACE INHIBITORS
LOTREL (CAPSULE) AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Drug Classes: CALCIUM CHANNEL BLOCKERS; ACE INHIBITORS; ANTIHYPERTENSIVES
NDA Applicant: NOVARTIS      NDA No.: 020364  Prod. No.: 006 RX (EQ 10MG BASE;40MG); 007 RX (EQ 5MG BASE;40MG)

Patents	Expiration	Patented Use
Pat. No. 4879303 DS* DP* Pharmaceutically acceptable salts Claim Types: Compound;Composition; Formulation	MAR 25,2007
Pat. No. 6162802 DS* DP* Synergistic combination therapy using benazepril and amlodipine for the treatment of cardiovascular disorders and compositions therefor Claim Types: Method of use; Formulation	DEC 19,2017	U-185: Method of treating hypertension
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NS - New strength	APR 11,2009

ACE INHIBITORS
MAVIK (TABLET) TRANDOLAPRIL
Drug Classes: ACE INHIBITORS; ANTIHYPERTENSIVES
NDA Applicant: ABBOTT      NDA No.: 020528  Prod. No.: 001 RX (1MG); 002 RX (2MG); 003 RX (4MG)

Patents	Expiration	Patented Use
Pat. No. 4933361 Derivatives of bicyclic aminoacids agents containing these compounds and their use Claim Types: Compound; Composition; Method of use	JUN 12,2007
Pat. No. 5744496 Method of treating cardiac insufficiency using angiotensin-converting enzyme inhibitors Claim Types: Method of use	APR 28,2015	U-229: Cardiac insufficiency (congestive heart failure)

ACE INHIBITORS
MICARDIS HCT (TABLET) HYDROCHLOROTHIAZIDE; TELMISARTAN
Drug Classes: ACE INHIBITORS; ANTIHYPERTENSIVES
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 021162  Prod. No.: 001 RX (12.5MG;40MG); 002 RX (12.5MG;80MG)

Patents	Expiration	Patented Use
Pat. No. 5591762 Benzimidazoles useful as angiotensin-11 antagonists Claim Types: Compound; Composition; Method of use	JAN 07,2014	U-3: Treatment of hypertension
Pat. No. 6358986 Polymorphs of telmisartan Claim Types: Formulation	JAN 10,2020

ACE INHIBITORS
MONOPRIL (TABLET) FOSINOPRIL SODIUM [GENERIC AB]
Drug Classes: ACE INHIBITORS; ANTIHYPERTENSIVES; HYPOTENSION/SHOCK
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 019915  Prod. No.: 002 RX (10MG); 003 RX (20MG); 004 RX (40MG)

Patents	Expiration	Patented Use
Pat. No. 5006344 Fosinopril tablet formulations Claim Types: Formulation	JAN 10,2010 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NPP - New patient population	Nov 27,2006 PED

ACE INHIBITORS
MONOPRIL-HCT (TABLET) FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE [GENERIC AB]
Drug Classes: DIURETICS; ACE INHIBITORS
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 020286  Prod. No.: 001 RX (20MG;12.5MG); 002 RX (10MG;12.5MG)

Patents	Expiration	Patented Use
Pat. No. 5006344 Fosinopril tablet formulations Claim Types: Formulation	JAN 10,2010 *PED

ACE INHIBITORS
PRINIVIL (TABLET) LISINOPRIL [GENERIC AB]
Drug Classes: ANTIHYPERTENSIVES; ACE INHIBITORS
NDA Applicant: MERCK      NDA No.: 019558  Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (20MG); 004 RX (40MG) NDA No.: 019558  Prod. No.: 006 DISC (2.5MG)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NPP - New patient population	Nov 29,2006 PED

ACE INHIBITORS
ZESTRIL (TABLET) LISINOPRIL [GENERIC AB]
Drug Classes: ANTIHYPERTENSIVES; ACE INHIBITORS
NDA Applicant: ASTRAZENECA      NDA No.: 019777  Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (20MG); 004 RX (40MG); 005 RX (2.5MG)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NPP - New patient population	Nov 29,2006 PED

ACE INHIBITORS
ZESTRIL (TABLET) LISINOPRIL [GENERIC AB]
Drug Classes: ANTIHYPERTENSIVES; ACE INHIBITORS
NDA Applicant: ASTRAZENECA      NDA No.: 019777  Prod. No.: 006 RX (30MG)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NPP - New patient population	MAY 29,2006

ACNE PRODUCTS
AVITA (CREAM) TRETINOIN [GENERIC AB]
Drug Classes: ACNE PRODUCTS; DERMATOLOGICS
NDA Applicant: MYLAN BERTEK      NDA No.: 020404  Prod. No.: 003 RX (0.025%)

Patents	Expiration	Patented Use
Pat. No. 4971800 Method and compositions for enhancing the cutaneous penetration of pharmacologically active agents Claim Types: Excipient; Method of administration	NOV 20,2007	U-178: Facilitated adherence of agents to skin
Pat. No. 5045317 Enhancing the cutaneous penetration of pharmacologically active agents Claim Types: Formulation	SEP 03,2008	U-179: Enhanced cutaneous penetration of a dermally-applied pharmacologically active agent
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code ODE: Orphan Drug	JUN 04,2008

ACNE PRODUCTS
DIFFERIN (GEL) ADAPALENE
Drug Classes: ACNE PRODUCTS
NDA Applicant: GALDERMA LABS LP      NDA No.: 020380  Prod. No.: 001 RX (0.1%)

Patents	Expiration	Patented Use
Pat. No. 4717720 [Extended 1512 days (4.1 years)] Benzonaphthalene derivatives and compositions Claim Types: Compound; Composition	MAY 31,2010
Pat. No. RE34440 [Extended 433 days (1.2 years)] Benzonaphthalene derivatives, a process for their preparation and their use in therapeutic and cosmetic compositions Claim Types: Method of use; Composition	MAY 31,2010	U-275: Method of use of the drug substance

ACNE PRODUCTS
FINACEA (GEL) AZELAIC ACID
Drug Classes: ACNE PRODUCTS
NDA Applicant: INTENDIS      NDA No.: 021470  Prod. No.: 001 RX (15%)

Patents	Expiration	Patented Use
Pat. No. 4713394 Treatment of nonacne inflammatory and infectious dermatoses and hair loss Claim Types: Method of use	JAN 17,2006	U-492: Method for the treatment of skin, suffering from a condition selected from a group consisting of non-acne inflammatory dermatoses comprising applying to affected area a therapeutically effective amt azelaic acid
Pat. No. 6534070 Composition with azelaic acid Claim Types: Formulation; Method of use	NOV 18,2018

ACNE PRODUCTS
RETIN-A MICRO (GEL) TRETINOIN
Drug Classes: DERMATOLOGICS; ACNE PRODUCTS
NDA Applicant: JOHNSON AND JOHNSON      NDA No.: 020475  Prod. No.: 001 RX (0.1%)

Patents	Expiration	Patented Use
Pat. No. 5955109 DP* Methods and compositions for topical delivery of retinoic acid Claim Types: Formulation; Method of administration	SEP 21,2016	U-134: Treatment of acne vulgaris

ACNE PRODUCTS
RETIN-A MICRO (GEL) TRETINOIN
Drug Classes: DERMATOLOGICS; ACNE PRODUCTS
NDA Applicant: JOHNSON AND JOHNSON      NDA No.: 020475  Prod. No.: 002 RX (0.04%)

Patents	Expiration	Patented Use
Pat. No. 5955109 Methods and compositions for topical delivery of retinoic acid Claim Types: Formulation; Method of administration	SEP 21,2016	U-134: Treatment of acne vulgaris

ACNE PRODUCTS
TAZORAC (GEL) TAZAROTENE
Drug Classes: ACNE PRODUCTS; DERMATITIS/ANTIPURETICS
NDA Applicant: ALLERGAN      NDA No.: 020600  Prod. No.: 001 RX (0.05%); 002 RX (0.1%)

Patents	Expiration	Patented Use
Pat. No. 5089509 [Extended 845 days* (2.3 years)] Disubstituted acetylenes bearing heteroaromatic and heterobicyclic groups having retinoid like activity Claim Types: Compound; Composition; Method of use	JUN 13,2011	U-193: Psoriasis
Pat. No. 5089509 [Extended 845 days* (2.3 years)] Disubstituted acetylenes bearing heteroaromatic and heterobicyclic groups having retinoid like activity Claim Types: Compound; Composition; Method of use	JUN 13,2011	U-481: Disubstituted acetylenes bearing heteroaromatic and heterobicyclic groups having retinoid-like activity
Pat. No. 5914334 Stable gel formulation for topical treatment of skin conditions Claim Types: Formulation; Process	JUN 07,2014	U-517: Stable gel formulation for topical treatment of skin conditions
Pat. No. 6258830 Stable gel formulation for topical treatment of skin conditions Claim Types: Formulation	JUN 07,2014	U-517: Stable gel formulation for topical treatment of skin conditions

ACNE PRODUCTS
TAZORAC; AVAGE (CREAM) TAZAROTENE
Drug Classes: ACNE PRODUCTS
NDA Applicant: ALLERGAN      NDA No.: 021184  Prod. No.: 001 RX (0.05%); 002 RX (0.1%); 003 RX (0.1%)

Patents	Expiration	Patented Use
Pat. No. 5089509 [Extended 845 days* (2.3 years)] Disubstituted acetylenes bearing heteroaromatic and heterobicyclic groups having retinoid like activity Claim Types: Compound; Composition; Method of use	JUN 13,2011	U-481: Disubstituted acetylenes bearing heteroaromatic and heterobicyclic groups having retinoid-like activity

ADRENAL CORTICOSTEROIDS
ELOCON (LOTION) MOMETASONE FUROATE [GENERIC AB]
Drug Classes: ADRENAL CORTICOSTEROIDS; DERMATOLOGICS
NDA Applicant: SCHERING      NDA No.: 019796  Prod. No.: 001 RX (0.1%)

Patents	Expiration	Patented Use
Pat. No. 4775529 Steroid lotion Claim Types: Formulation; Method of use	NOV 21,2007 *PED

ADRENAL CORTICOSTEROIDS
ELOCON (CREAM) MOMETASONE FUROATE [GENERIC AB]
Drug Classes: DERMATOLOGICS; ADRENAL CORTICOSTEROIDS; TOPICAL STEROIDS
NDA Applicant: SCHERING      NDA No.: 019625  Prod. No.: 001 RX (0.1%)

Patents	Expiration	Patented Use
Pat. No. 4808610 Mometasone furoate anti-inflammatory cream composition using hexylene glycol Claim Types: Formulation	APR 02,2007 *PED

ADRENAL CORTICOSTEROIDS
NASALIDE (SPRAY, METERED) FLUNISOLIDE [Has competitive generic]
Drug Classes: ADRENAL CORTICOSTEROIDS; NASAL DECONGESTANTS; CORTICOSTEROIDS-INHALATION/NASAL
NDA Applicant: IVAX RES      NDA No.: 018148  Prod. No.: 001 DISC (0.025MG/SPRAY)

Patents	Expiration	Patented Use
Pat. No. 4933168 Stable, crystalline flunisolide Claim Types: New polymorph, salt or hydrate; Formulation; Method of use	JUN 12,2007

ADRENAL CORTICOSTEROIDS
PREMARIN (TABLET) ESTROGENS, CONJUGATED
Drug Classes: ESTROGENS/PROGESTINS; ANTINEOPLASTICS; ADRENAL CORTICOSTEROIDS
NDA Applicant: WYETH PHARMS INC      NDA No.: 004782  Prod. No.: 001 RX (1.25MG); 004 RX (0.625MG); 005 RX (0.9MG) NDA No.: 004782  Prod. No.: 002 DISC (2.5MG)

Patents	Expiration	Patented Use
Pat. No. 5210081 Alkali metal 8,9-dehydroestrone sulfate esters Claim Types: Composition	FEB 26,2012

ADRENAL CORTICOSTEROIDS
PREMARIN (TABLET) ESTROGENS, CONJUGATED
Drug Classes: ESTROGENS/PROGESTINS; ANTINEOPLASTICS; ADRENAL CORTICOSTEROIDS
NDA Applicant: WYETH PHARMS INC      NDA No.: 004782  Prod. No.: 006 RX (0.45MG)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: D - New Dosing Schedule	JUL 16,2006	D-82: Use of PREMARIN 0.3 mg and 0.45 mg for the prevention of postmenopausal osteoporosis

ADRENAL CORTICOSTEROIDS
PREMARIN (TABLET) ESTROGENS, CONJUGATED
Drug Classes: ESTROGENS/PROGESTINS; ANTINEOPLASTICS; ADRENAL CORTICOSTEROIDS
NDA Applicant: WYETH PHARMS INC      NDA No.: 004782  Prod. No.: 003 RX (0.3MG)

Patents	Expiration	Patented Use
Pat. No. 5210081 Alkali metal 8,9-dehydroestrone sulfate esters Claim Types: Composition	FEB 26,2012
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: D - New Dosing Schedule	JUL 16,2006	D-82: Use of PREMARIN 0.3 mg and 0.45 mg for the prevention of postmenopausal osteoporosis

ADRENAL CORTICOSTEROIDS
PULMICORT RESPULES (SUSPENSION) BUDESONIDE
Drug Classes: ADRENAL CORTICOSTEROIDS
NDA Applicant: ASTRAZENECA      NDA No.: 020929  Prod. No.: 001 RX (0.25MG/2ML); 002 RX (0.5MG/2ML)

Patents	Expiration	Patented Use
Pat. No. 4787536 Dosage package Claim Types: Device; Process	AUG 27,2006 *PED
Pat. No. 6598603 Method for treating respiratory diseases Claim Types: Method of use; Kit	JUN 23,2019 *PED	U-529: Once daily treatment of asthma with nebulized budesonide
Pat. No. 6899099 Method for treating a respiratory disease Claim Types: Kit; Method of use	JUN 23,2019 *PED	U-751: Once daily dosing of budesonide via nebulizer for the treatment of asthma

ADRENAL CORTICOSTEROIDS
PULMICORT RESPULES (SUSPENSION) BUDESONIDE
Drug Classes: ADRENAL CORTICOSTEROIDS
NDA Applicant: ASTRAZENECA      NDA No.: 020929  Prod. No.: 003 DISC (1MG/2ML)

Patents	Expiration	Patented Use
Pat. No. 4787536 Dosage package Claim Types: Device; Process	AUG 27,2006 *PED
Pat. No. 6598603 Method for treating respiratory diseases Claim Types: Method of use; Kit	JUN 23,2019 *PED	U-529: Once daily treatment of asthma with nebulized budesonide

ADRENAL CORTICOSTEROIDS
QVAR 80; QVAR 40 (AEROSOL, METERED) BECLOMETHASONE DIPROPIONATE
Drug Classes: ADRENAL CORTICOSTEROIDS; CORTICOSTEROIDS-INHALATION/NASAL; ANTIASTHMATICS/BRONCODILATORS
NDA Applicant: 3M      NDA No.: 020911  Prod. No.: 001 RX (0.08MG/INH); 002 RX (0.04MG/INH)

Patents	Expiration	Patented Use
Pat. No. 5605674 Medicinal aerosol formulations Claim Types: Formulation	FEB 25,2014
Pat. No. 5683677 Medicinal aerosol formulations Claim Types: Formulation	NOV 04,2014
Pat. No. 5695743 Medicinal aerosol formulations Claim Types: Formulation; Method of administration; Method of use	JUL 06,2010
Pat. No. 5766573 Medicinal aerosol formulations Claim Types: Method of administration	NOV 28,2009	U-356: Delivering a medicinal aerosol formulation using CFC-free propellant 134a.
Pat. No. 5776432 Beclomethasone solution aerosol formulations Claim Types: Formulation; Method of use	JUL 07,2015
Pat. No. 6352684 CRC-free medicinal aerosol formulations of 1,1,1,2-tetrafluoroethane (134A) with polar adjuvant Claim Types: Formulation	NOV 28,2009

ADRENAL CORTICOSTEROIDS
RHINOCORT (SPRAY, METERED) BUDESONIDE
Drug Classes: ADRENAL CORTICOSTEROIDS; CORTICOSTEROIDS-INHALATION/NASAL
NDA Applicant: ASTRAZENECA      NDA No.: 020746  Prod. No.: 001 RX (0.032MG/INH) NDA No.: 020746  Prod. No.: 002 DISC (0.064MG/INH)

Patents	Expiration	Patented Use
Pat. No. 6291445 Low dose budesonide formulations and uses thereof Claim Types: Formulation; Drug in a container; Method of use	OCT 29,2017 *PED
Pat. No. 6686346 DP* Formulation Claim Types: Formulation; Method of use; Device	APR 29,2017	U-557: Nasal treatment of seasonal and perennial allergic rhinitis symptoms
Pat. No. 6986904 DP* Formulation Claim Types: Composition; Method of use; Formulation	APR 29,2017	U-699: Nasal treatment of seasonal and perennial allergic rhinitis symptoms

ALPHA AGONISTS/ALPHA BLOCKERS
CADUET (TABLET) AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Drug Classes: CALCIUM CHANNEL BLOCKERS; ALPHA AGONISTS/ALPHA BLOCKERS
NDA Applicant: PFIZER      NDA No.: 021540  Prod. No.: 001 RX (EQ 5MG BASE;EQ 10MG BASE); 002 RX (EQ 5MG BASE;EQ 20MG BASE); 003 RX (EQ 5MG BASE;EQ 40MG BASE); 004 RX (EQ 5MG BASE;EQ 80MG BASE); 005 RX (EQ 10MG BASE;EQ 10MG BASE); 006 RX (EQ 10MG BASE;EQ 20MG BASE); 007 RX (EQ 10MG BASE;EQ 40MG BASE); 008 RX (EQ 10MG BASE;EQ 80MG BASE); 009 RX (EQ 2.5MG BASE;EQ 10MG BASE); 010 RX (EQ 2.5MG BASE;EQ 20MG BASE); 011 RX (EQ 2.5MG BASE;EQ 40MG BASE)

Patents	Expiration	Patented Use
Pat. No. 4572909 DS* DP* [Extended 1252 days (3.4 years)] 2-(Secondary aminoalkoxymethyl) dihydropyridine derivatives as anti-ischaemic and antihypertensive agents Claim Types: Compound; Composition; Method of use Comments: Amlodipine and its salts, generally.	JAN 31,2007 *PED	U-3: Treatment of hypertension
Pat. No. 4681893 DS* DP* [Extended 1213 days (3.3 years)] Trans-6-[2-(3- or 4-carboxamido-substituted pyrrol-1-yl)alkyl]-4-hydroxypyran-2-one inhibitors of cholesterol synthesis Claim Types: Compound; Composition; Method of use	MAR 24,2010 *PED	U-161: Method of inhibiting cholesterol biosynthesis in a patient
Pat. No. 4879303 DS* DP* Pharmaceutically acceptable salts Claim Types: Compound;Composition; Formulation	SEP 25,2007 *PED
Pat. No. 5273995 DS* DP* [R-(R*R*)]-2-(4-fluorophenyl)-.beta.,.delta.-dihydroxy-5- (1-methylethyl-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid, its lactone form and salts thereof Claim Types: Compound; Composition; Method of use Comments: Specific stereoisomer of atorvastatin	JUN 28,2011 *PED	U-162: Method of use to inhibit cholesterol synthesis in a human suffering from hypercholesterolemia
Pat. No. 5686104 DP* Stable oral CI-981 formulation and process of preparing same Claim Types: Formulation; Process; Method of use	MAY 11,2015 *PED	U-213: Method of inhibiting cholesterol biosynthesis and treating hypercholesterolemia and method for treating hyperlipidemia
Pat. No. 5969156 DS* Crystalline [R-(R*,R*)]-2-(4-Dfluorophenyl)- .beta.,.delta.-dihydroxy-5-(1-methylethyl)-3-phenyl- 4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid hemi calcium salt (atorvastatin) Claim Types: New polymorph, salt or hydrate	JAN 08,2017 *PED
Pat. No. 6126971 DP* Stable oral CI-981 formulation and process for preparing same Claim Types: Formulation; Method of improving a formulation	JUL 19,2013 *PED
Pat. No. 6455574 Therapeutic combination Claim Types: Method of use	AUG 11,2018	U-552: Treatment of hypertension and hyperlipidemia with a single composition
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NC - New combination	JAN 30,2007

ALPHA AGONISTS/ALPHA BLOCKERS
HYTRIN (CAPSULE) TERAZOSIN HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANTIHYPERTENSIVES; ALPHA AGONISTS/ALPHA BLOCKERS
NDA Applicant: ABBOTT      NDA No.: 020347  Prod. No.: 001 RX (EQ 1MG BASE); 002 RX (EQ 2MG BASE); 003 RX (EQ 5MG BASE); 004 RX (EQ 10MG BASE)

Patents	Expiration	Patented Use
Pat. No. 5212176 R(+)-terazosin Claim Types: Compound; Composition; Method of use	JUN 29,2010
Pat. No. 5294615 Terazosin polymorph and pharmaceutical composition Claim Types: New polymorph, salt or hydrate; Composition; Method of use	APR 29,2013	U-165: Treatment of symptomatic benign prostatic hyperplasia
Pat. No. 5294615 Terazosin polymorph and pharmaceutical composition Claim Types: New polymorph, salt or hydrate; Composition; Method of use	APR 29,2013	U-3: Treatment of hypertension
Pat. No. 5412095 Terazosin monohydrochloride and processes and intermediate for its production Claim Types: New polymorph, salt or hydrate	APR 29,2013

ALPHA AGONISTS/ALPHA BLOCKERS
MICARDIS (TABLET) TELMISARTAN
Drug Classes: ANTIHYPERTENSIVES; ALPHA AGONISTS/ALPHA BLOCKERS
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 020850  Prod. No.: 001 RX (40MG); 002 RX (80MG); 003 RX (20MG)

Patents	Expiration	Patented Use
Pat. No. 5591762 Benzimidazoles useful as angiotensin-11 antagonists Claim Types: Compound; Composition; Method of use	JAN 07,2014	U-3: Treatment of hypertension
Pat. No. 6358986 Polymorphs of telmisartan Claim Types: Formulation	JAN 10,2020

ALZHEIMER-TYPE DEMENTIA
ARICEPT (TABLET) DONEPEZIL HYDROCHLORIDE
Drug Classes: ALZHEIMER-TYPE DEMENTIA
NDA Applicant: EISAI MEDCL RES      NDA No.: 020690  Prod. No.: 001 RX (10MG); 002 RX (5MG)

Patents	Expiration	Patented Use
Pat. No. 4895841 [Extended 888 days* (2.4 years)] Cyclic amine compounds with activity against acetylcholinesterase Claim Types: Compound; Composition; Method of use	NOV 25,2010
Pat. No. 5985864 Polymorphs of donepezil hydrochloride and process for production Claim Types: New polymorph, salt or hydrate; Composition; Process; Method of use	DEC 30,2016
Pat. No. 6140321 Polymorphs of donepezil hydrochloride and process for production Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process	DEC 30,2016
Pat. No. 6245911 Donepezil polycrystals and process for producing the same Claim Types: New polymorph, salt or hydrate; Process	DEC 01,2018
Pat. No. 6372760 Stabilized composition comprising antidementia medicament Claim Types: Formulation; Method of improving a formulation	MAR 31,2019

ALZHEIMER-TYPE DEMENTIA
EXELON (CAPSULE) RIVASTIGMINE TARTRATE
Drug Classes: ALZHEIMER-TYPE DEMENTIA
NDA Applicant: NOVARTIS      NDA No.: 020823  Prod. No.: 003 RX (EQ 1.5MG BASE); 004 RX (EQ 3MG BASE); 005 RX (EQ 4.5MG BASE); 006 RX (EQ 6MG BASE)

Patents	Expiration	Patented Use
Pat. No. 4948807 DS* Phenyl carbamates Claim Types: Compound; Method of use	AUG 14,2012	U-322: Treatment of Alzheimer's dementia
Pat. No. 5602176 Phenyl carbamate Claim Types: Compound; Method of use	FEB 11,2014	U-322: Treatment of Alzheimer's dementia

ALZHEIMER-TYPE DEMENTIA
RAZADYNE (TABLET) GALANTAMINE HYDROBROMIDE
Drug Classes: ALZHEIMER-TYPE DEMENTIA
NDA Applicant: JANSSEN PHARMA      NDA No.: 021169  Prod. No.: 001 RX (EQ 4MG BASE); 002 RX (EQ 8MG BASE); 003 RX (EQ 12MG BASE)

Patents	Expiration	Patented Use
Pat. No. 4663318 [Extended 1064 days (2.9 years)] Method of treating Alzheimer's disease Claim Types: Method of use	DEC 14,2008	U-322: Treatment of Alzheimer's dementia
Pat. No. 6099863 Fast-dissolving galanthamine hydrobromide tablet Claim Types: Formulation	JUN 06,2017
Pat. No.