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. 6358527 DP* Fast-dissolving galanthamine hydrobromide tablet Claim Types: Method of use; Formulation	JUN 06,2017	U-322: Treatment of Alzheimer's dementia
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	FEB 28,2006

ALZHEIMER-TYPE DEMENTIA
RAZADYNE (SOLUTION) GALANTAMINE HYDROBROMIDE
Drug Classes: ALZHEIMER-TYPE DEMENTIA
NDA Applicant: JANSSEN PHARMA      NDA No.: 021224  Prod. No.: 001 RX (4MG/ML)

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
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	FEB 28,2006

ANALGESICS, GENERAL
ACULAR LS (SOLUTION/DROPS) KETOROLAC TROMETHAMINE
Drug Classes: ANALGESICS, GENERAL
NDA Applicant: ALLERGAN      NDA No.: 021528  Prod. No.: 001 RX (0.4%)

Patents	Expiration	Patented Use
Pat. No. 5110493 Ophthalmic NSAID formulations containing a quaternary ammonium preservative and a nonionic surfactant Claim Types: Formulation; Excipient	NOV 05,2009 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	MAY 30,2006

ANALGESICS, GENERAL
AVINZA (CAPSULE, EXTENDED RELEASE) MORPHINE SULFATE
Drug Classes: ANALGESICS, GENERAL
NDA Applicant: LIGAND      NDA No.: 021260  Prod. No.: 001 RX (30MG); 002 RX (60MG); 003 RX (90MG); 004 RX (120MG)

Patents	Expiration	Patented Use
Pat. No. 6066339 Oral morphine multiparticulate formulation Claim Types: Formulation	NOV 25,2017

ANALGESICS, GENERAL
BEXTRA (TABLET) VALDECOXIB
Drug Classes: ANALGESICS, GENERAL; NSAID
NDA Applicant: SEARLE, GD LLC      NDA No.: 021341  Prod. No.: 002 RX (10MG); 003 RX (20MG)

Patents	Expiration	Patented Use
Pat. No. 5633272 Substituted isoxazoles for the treatment of inflammation Claim Types: Compound; Composition; Method of use	FEB 13,2015	U-462: Signs and symptoms of osteoarthritis and adult rheumatoid arthritis and treatment of primary dysmenorrhea
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	NOV 16,2006

ANALGESICS, GENERAL
CELEBREX (CAPSULE) CELECOXIB
Drug Classes: NSAID; ANALGESICS, GENERAL
NDA Applicant: SEARLE, GD LLC      NDA No.: 020998  Prod. No.: 002 RX (200MG); 003 RX (400MG)

Patents	Expiration	Patented Use
Pat. No. 5466823 DS* Substituted pyrazolyl benzenesulfonamides Claim Types: Compound	MAY 30,2014 *PED
Pat. No. 5563165 DP* Substituted pyrazolyl benzenesulfonamides for the treatment of inflammation Claim Types: Composition	MAY 30,2014 *PED
Pat. No. 5760068 Substituted pyrazolyl benzenesulfonamides for the treatment of inflammation Claim Types: Method of use	DEC 02,2015 *PED	U-299: Treatment of adenomatous polyps
Pat. No. 5972986 Method of using cyclooxygenase-2 inhibitors in the treatment and prevention of neoplasia Claim Types: Method of use	APR 14,2018 *PED	U-299: Treatment of adenomatous polyps
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Jan 29,2009 PED	I-466: For relief of the signs and symptoms of ankylosing spondylitis

ANALGESICS, GENERAL
CELEBREX (CAPSULE) CELECOXIB
Drug Classes: NSAID; ANALGESICS, GENERAL
NDA Applicant: SEARLE, GD LLC      NDA No.: 020998  Prod. No.: 001 RX (100MG)

Patents	Expiration	Patented Use
Pat. No. 5466823 DS* Substituted pyrazolyl benzenesulfonamides Claim Types: Compound	MAY 30,2014 *PED
Pat. No. 5563165 DP* Substituted pyrazolyl benzenesulfonamides for the treatment of inflammation Claim Types: Composition	MAY 30,2014 *PED
Pat. No. 5760068 Substituted pyrazolyl benzenesulfonamides for the treatment of inflammation Claim Types: Method of use	DEC 02,2015 *PED	U-672: Treatment of inflammation or an inflammation-associated disorder
Pat. No. 5972986 Method of using cyclooxygenase-2 inhibitors in the treatment and prevention of neoplasia Claim Types: Method of use	APR 14,2018 *PED	U-299: Treatment of adenomatous polyps
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Jan 29,2009 PED	I-466: For relief of the signs and symptoms of ankylosing spondylitis

ANALGESICS, GENERAL
DURAGESIC-100; DURAGESIC-75; DURAGESIC-50; DURAGESIC-25; DURAGESIC-12 (FILM, EXTENDED RELEASE) FENTANYL [GENERIC AB]
Drug Classes: ANALGESICS-NARCOTIC; ANALGESICS, GENERAL
NDA Applicant: ALZA      NDA No.: 019813  Prod. No.: 001 RX (100UGM/HR); 002 RX (75UGM/HR); 003 RX (50UGM/HR); 004 RX (25UGM/HR); 005 RX (12.5UGM/HR)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NPP - New patient population	Nov 20,2006 PED

ANALGESICS, GENERAL
MOTRIN, JUNIOR STRENGTH (SUSPENSION) IBUPROFEN [GENERIC AB]
Drug Classes: ANALGESICS-NON-NARCOTIC; ANTIPYRETICS; ANALGESICS, GENERAL
NDA Applicant: MCNEIL CONS SPECLT      NDA No.: 019842  Prod. No.: 001 RX (100MG/5ML)

Patents	Expiration	Patented Use
Pat. No. 5374659 Aqueous pharmaceutical suspension for substantially water insoluble pharmaceutical actives Claim Types: Formulation	JUN 20,2012 *PED

ANALGESICS, GENERAL
OXYCONTIN (TABLET, EXTENDED RELEASE) OXYCODONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANALGESICS, GENERAL; ANALGESICS-NARCOTIC
NDA Applicant: PURDUE PHARMA LP      NDA No.: 020553  Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (40MG); 004 RX (80MG) NDA No.: 020553  Prod. No.: 005 DISC (160MG)

Patents	Expiration	Patented Use
Pat. No. 4861598 Controlled release bases for pharmaceuticals Claim Types: Formulation	AUG 29,2006
Pat. No. 4970075 Controlled release bases for pharmaceuticals Claim Types: Formulation	AUG 29,2006
Pat. No. 5266331 Controlled release oxycodone compositions Claim Types: Formulation; Process	OCT 26,2007
Pat. No. 5508042 Controlled release oxycodone compositions Claim Types: Method of use	APR 16,2013	U-443: Management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time
Pat. No. 5549912 Controlled release oxycodone compositions Claim Types: Formulation	OCT 26,2007
Pat. No. 5656295 Controlled release oxycodone compositions Claim Types: Formulation; Method of use	OCT 26,2007	U-443: Management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time

ANALGESICS, GENERAL
PRECEDEX (INJECTABLE) DEXMEDETOMIDINE
Drug Classes: SEDATIVES/HYPNOTICS; ANALGESICS, GENERAL
NDA Applicant: HOSPIRA      NDA No.: 021038  Prod. No.: 001 RX (EQ 100UGM BASE/ML)

Patents	Expiration	Patented Use
Pat. No. 4910214 DS* DP* Optical isomer of an imidazole derivative medetomidine as an alpha-2-receptor agonist Claim Types: Compound; Method of use	JUL 15,2013	U-421: Use for sedation
Pat. No. 6716867 Use of dexmedetomidine for ICU sedation Claim Types: Method of use	MAR 31,2019	U-572: Intensive care unit sedation

ANALGESICS, GENERAL
SUBOXONE (TABLET) BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Drug Classes: ANTIDOTES, SPECIFIC; ANALGESICS, GENERAL
NDA Applicant: RECKITT BENCKISER      NDA No.: 020733  Prod. No.: 001 RX (2MG;0.5MG); 002 RX (8MG;2MG)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code ODE: Orphan Drug	OCT 08,2009	Treatment of opiate addiction in opiate users.

ANALGESICS, GENERAL
SUBUTEX (TABLET) BUPRENORPHINE HYDROCHLORIDE
Drug Classes: ANALGESICS, GENERAL
NDA Applicant: RECKITT BENCKISER      NDA No.: 020732  Prod. No.: 002 RX (EQ 2MG BASE); 003 RX (EQ 8MG BASE)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code ODE: Orphan Drug	OCT 08,2009	Treatment of opiate addiction in opiate users.

ANALGESICS, GENERAL
ULTRACET (TABLET) ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANALGESICS, GENERAL
NDA Applicant: ORTHO MCNEIL PHARM      NDA No.: 021123  Prod. No.: 001 RX (325MG;37.5MG)

Patents	Expiration	Patented Use
Pat. No. RE39221 DS* DP* Composition comprising a tramadol material and acetaminophen and its use Claim Types: Formulation; Method of use	AUG 09,2011	U-55: Treatment of pain

ANALGESICS-NARCOTIC
ACTIQ (SUGAR-FREE) (TROCHE/LOZENGE) FENTANYL CITRATE
Drug Classes: ANALGESICS-NARCOTIC
NDA Applicant: CEPHALON      NDA No.: 020747  Prod. No.: 001 RX (EQ 0.2MG BASE); 002 RX (EQ 0.4MG BASE); 003 RX (EQ 0.6MG BASE); 004 RX (EQ 0.8MG BASE); 005 RX (EQ 1.2MG BASE); 006 RX (EQ 1.6MG BASE)

Patents	Expiration	Patented Use
Pat. No. 4863737 Compositions and methods of manufacture of compressed powder medicaments Claim Types: Device; Process	SEP 05,2006

ANALGESICS-NARCOTIC
DURAGESIC-100; DURAGESIC-75; DURAGESIC-50; DURAGESIC-25; DURAGESIC-12 (FILM, EXTENDED RELEASE) FENTANYL [GENERIC AB]
Drug Classes: ANALGESICS-NARCOTIC; ANALGESICS, GENERAL
NDA Applicant: ALZA      NDA No.: 019813  Prod. No.: 001 RX (100UGM/HR); 002 RX (75UGM/HR); 003 RX (50UGM/HR); 004 RX (25UGM/HR); 005 RX (12.5UGM/HR)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NPP - New patient population	Nov 20,2006 PED

ANALGESICS-NARCOTIC
KADIAN (CAPSULE, EXTENDED RELEASE) MORPHINE SULFATE
Drug Classes: ANALGESICS-NARCOTIC
NDA Applicant: ALPHARMA US PHARMS      NDA No.: 020616  Prod. No.: 001 RX (20MG); 002 RX (50MG); 003 RX (100MG); 004 RX (30MG); 005 RX (60MG)

Patents	Expiration	Patented Use
Pat. No. 5202128 Sustained release pharmaceutical composition Claim Types: Formulation; Method of use	APR 13,2010
Pat. No. 5378474 Sustained release pharmaceutical composition Claim Types: Formulation	MAR 23,2010

ANALGESICS-NARCOTIC
OXYCONTIN (TABLET, EXTENDED RELEASE) OXYCODONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANALGESICS, GENERAL; ANALGESICS-NARCOTIC
NDA Applicant: PURDUE PHARMA LP      NDA No.: 020553  Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (40MG); 004 RX (80MG) NDA No.: 020553  Prod. No.: 005 DISC (160MG)

Patents	Expiration	Patented Use
Pat. No. 4861598 Controlled release bases for pharmaceuticals Claim Types: Formulation	AUG 29,2006
Pat. No. 4970075 Controlled release bases for pharmaceuticals Claim Types: Formulation	AUG 29,2006
Pat. No. 5266331 Controlled release oxycodone compositions Claim Types: Formulation; Process	OCT 26,2007
Pat. No. 5508042 Controlled release oxycodone compositions Claim Types: Method of use	APR 16,2013	U-443: Management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time
Pat. No. 5549912 Controlled release oxycodone compositions Claim Types: Formulation	OCT 26,2007
Pat. No. 5656295 Controlled release oxycodone compositions Claim Types: Formulation; Method of use	OCT 26,2007	U-443: Management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time

ANALGESICS-NARCOTIC
VICOPROFEN (TABLET) HYDROCODONE BITARTRATE; IBUPROFEN [GENERIC AB]
Drug Classes: ANALGESICS-NARCOTIC; NSAID; ANTITUSSIVES/EXPECTORANTS/MUCOLYTICS
NDA Applicant: ABBOTT      NDA No.: 020716  Prod. No.: 001 RX (7.5MG;200MG)

Patents	Expiration	Patented Use
Pat. No. 6348216 Ibuprofen and narcotic analgesic compositions Claim Types: Formulation	JUN 10,2017
Pat. No. 6599531 Method of making ibuprofen and narcotic analgesic compositions Claim Types: Product-by-process	JUN 10,2017

ANALGESICS-NON-NARCOTIC
MOTRIN, JUNIOR STRENGTH (SUSPENSION) IBUPROFEN [GENERIC AB]
Drug Classes: ANALGESICS-NON-NARCOTIC; ANTIPYRETICS; ANALGESICS, GENERAL
NDA Applicant: MCNEIL CONS SPECLT      NDA No.: 019842  Prod. No.: 001 RX (100MG/5ML)

Patents	Expiration	Patented Use
Pat. No. 5374659 Aqueous pharmaceutical suspension for substantially water insoluble pharmaceutical actives Claim Types: Formulation	JUN 20,2012 *PED

ANALGESICS-NON-NARCOTIC
QUADRAMET (INJECTABLE) SAMARIUM SM 153 LEXIDRONAM PENTASODIUM
Drug Classes: ANALGESICS-NON-NARCOTIC
NDA Applicant: CYTOGEN      NDA No.: 020570  Prod. No.: 001 RX (50mCi/ML)

Patents	Expiration	Patented Use
Pat. No. 4898724 [Extended 1511 days (4.1 years)] Organis amine phosphonic acid complexes for the treatment of calcific tumors Claim Types: Method of use; Formulation Comments: Orange Book expiration date does not include extension. Extended expiration date is March 28, 2011.	FEB 06,2007	U-187: Therapeutic treatment of calcific tumors

ANALGESICS-NON-NARCOTIC
ULTRAM (TABLET) TRAMADOL HYDROCHLORIDE [GENERIC AB]
Drug Classes: ANALGESICS-NON-NARCOTIC
NDA Applicant: ORTHO MCNEIL PHARM      NDA No.: 020281  Prod. No.: 002 RX (50MG) NDA No.: 020281  Prod. No.: 001 DISC (100MG)

Patents	Expiration	Patented Use
Pat. No. 6339105 Analgesic regimen Claim Types: Method of administration	APR 12,2020 *PED	U-435: A titration dosing regimen for the treatment of pain using an initial dose of about 25mg

ANDROGENS/ANABOLIC STEROIDS
ANDRODERM (FILM, EXTENDED RELEASE) TESTOSTERONE
Drug Classes: ANDROGENS/ANABOLIC STEROIDS
NDA Applicant: WATSON LABS      NDA No.: 020489  Prod. No.: 001 RX (2.5MG/24HR); 002 RX (5MG/24HR)

Patents	Expiration	Patented Use
Pat. No. 4849224 Device for administering an active agent to the skin or mucosa Claim Types: Device	NOV 12,2007
Pat. No. 4855294 Method for reducing skin irritation associated with drug/penetration enhancer compositions Claim Types: Formulation; Method of use	SEP 06,2008
Pat. No. 4863970 Penetration enhancement with binary system of oleic acid, oleins, and oleyl alcohol with lower alcohols Claim Types: Formulation	NOV 14,2006
Pat. No. 4983395 Device for administering an active agent to the skin or mucosa Claim Types: Device	NOV 12,2007
Pat. No. 5152997 Method and device for transdermally administering testosterone across nonscrotal skin at therapeutically effective levels Claim Types: Device; Method of use	DEC 11,2010	U-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
Pat. No. 5164190 Subsaturated transdermal drug delivery device exhibiting enhanced drug flux Claim Types: Device; Method of administration	DEC 11,2010

ANDROGENS/ANABOLIC STEROIDS
ANDROGEL (GEL) TESTOSTERONE [GENERIC AB]
Drug Classes: ANDROGENS/ANABOLIC STEROIDS
NDA Applicant: UNIMED PHARMS      NDA No.: 021015  Prod. No.: 001 RX (1%)

Patents	Expiration	Patented Use
Pat. No. 6503894 Pharmaceutical composition and method for treating hypogonadism Claim Types: Formulation; Device; Method of administration	AUG 30,2020	U-490: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone

ANDROGENS/ANABOLIC STEROIDS
CASODEX (TABLET) BICALUTAMIDE
Drug Classes: ANDROGENS/ANABOLIC STEROIDS
NDA Applicant: ASTRAZENECA      NDA No.: 020498  Prod. No.: 001 RX (50MG)

Patents	Expiration	Patented Use
Pat. No. 4636505 [Extended 1723 days (4.7 years)] Amide derivatives Claim Types: Compound; Composition; Method of use	OCT 01,2008

ANDROGENS/ANABOLIC STEROIDS
OXANDRIN (TABLET) OXANDROLONE
Drug Classes: ANDROGENS/ANABOLIC STEROIDS; HORMONES/HORMONAL MECHANISMS
NDA Applicant: SAVIENT PHARMS      NDA No.: 013718  Prod. No.: 001 RX (2.5MG); 002 RX (10MG)

Patents	Expiration	Patented Use
Pat. No. 5872147 Use of oxandrolone in the treatment of chronic obstructive pulmonary disease Claim Types: Method of use	DEC 05,2017	U-585: To promote weight gain after weight loss in certain types of patients
Pat. No. 6090799 Method for ameliorating muscle weakness/wasting in a patient infected with human immunodeficiency virus-type 1 Claim Types: Method of use	JUL 18,2017	U-585: To promote weight gain after weight loss in certain types of patients
Pat. No. 6576659 Use of oxandrolone in the treatment of burns an other wounds Claim Types: Method of use	DEC 05,2017	U-585: To promote weight gain after weight loss in certain types of patients
Pat. No. 6670351 Method for ameliorating muscle weakness/wasting in a patient infected with human immunodeficiency virus-type 1 Claim Types: Method of use	OCT 20,2012	U-585: To promote weight gain after weight loss in certain types of patients
Pat. No. 6828313 Use of oxandrolone in the treatment of burns and other wounds Claim Types: Method of use	DEC 05,2017	U-585: To promote weight gain after weight loss in certain types of patients
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	JUN 20,2008	M-42: Addition of a geriatric use subsection to the precautions section of the package insert and geriatric dosing information

ANDROGENS/ANABOLIC STEROIDS
PROPECIA (TABLET) FINASTERIDE [GENERIC AB]
Drug Classes: ANDROGENS/ANABOLIC STEROIDS
NDA Applicant: MERCK      NDA No.: 020788  Prod. No.: 001 RX (1MG)

Patents	Expiration	Patented Use
Pat. No. 4760071 [Extended 328 days (0.9 years)] 17.beta.-N-monosubstituted carbamoyl-4-aza-5.alpha.-androst-1-en-3-ones which are active as testosterone 5.alpha.-reductase inhibitors Claim Types: Compound; Composition; Method of use	JUN 19,2006
Pat. No. 5547957 Method of treating androgenic alopecia with 5-.alpha. reductase inhibitors Claim Types: Method of use	OCT 15,2013	U-236: Treating male pattern baldness with 0.05 to 3.0 mg/day
Pat. No. 5571817 Methods of treating androgenic alopecia with finasteride [17.beta.-N-mono-substituted-carbamoyl-4-aza-5-.alpha.-androst-1-en-ones] Claim Types: Method of use	NOV 05,2013	U-259: Treatment of androgenic alopecia by oral administration of drug substance
Pat. No. 5886184 Finasteride processes Claim Types: New polymorph, salt or hydrate; Product-by-process; Process	NOV 19,2012

ANDROGENS/ANABOLIC STEROIDS
TESTODERM (FILM, EXTENDED RELEASE) TESTOSTERONE
Drug Classes: ANDROGENS/ANABOLIC STEROIDS
NDA Applicant: ALZA      NDA No.: 019762  Prod. No.: 001 DISC (4MG/24HR); 002 DISC (6MG/24HR)

Patents	Expiration	Patented Use
Pat. No. 5840327 Transdermal drug delivery device having enhanced adhesion Claim Types: Device	AUG 15,2016

ANESTHESIA, ADJUNCTS TO/ANALEPTICS
NIMBEX; NIMBEX PRESERVATIVE FREE (INJECTABLE) CISATRACURIUM BESYLATE
Drug Classes: ANESTHESIA, ADJUNCTS TO/ANALEPTICS
NDA Applicant: ABBOTT      NDA No.: 020551  Prod. No.: 001 RX (EQ 2MG BASE/ML); 002 RX (EQ 10MG BASE/ML); 003 RX (EQ 2MG BASE/ML)

Patents	Expiration	Patented Use
Pat. No. 5453510 Neuromuscular blocking agents Claim Types: Formulation; Method of use	SEP 26,2012	U-127: Method of producing neuromuscular blockade

ANESTHESIA, ADJUNCTS TO/ANALEPTICS
ZEMURON (INJECTABLE) ROCURONIUM BROMIDE
Drug Classes: ANESTHESIA, ADJUNCTS TO/ANALEPTICS
NDA Applicant: ORGANON USA INC      NDA No.: 020214  Prod. No.: 001 RX (50MG/5ML(10MG/ML)); 003 RX (100MG/10ML(10MG/ML)) NDA No.: 020214  Prod. No.: 002 DISC (10MG/ML)

Patents	Expiration	Patented Use
Pat. No. 4894369 Novel 2.beta.-morpholino-androstane derivatives Claim Types: Compound; Composition	APR 13,2008

ANESTHETICS, GENERAL
DIPRIVAN (INJECTABLE) PROPOFOL [GENERIC AB]
Drug Classes: ANESTHETICS, GENERAL
NDA Applicant: ABRAXIS BIOSCIENCE      NDA No.: 019627  Prod. No.: 002 RX (10MG/ML)

Patents	Expiration	Patented Use
Pat. No. 5714520 Propofol compostion containing edetate Claim Types: Formulation	SEP 22,2015 *PED
Pat. No. 5731355 Pharmaceutical compositions of propofol and edetate Claim Types: Method of use	SEP 22,2015 *PED	U-217: Method of producing anesthesia
Pat. No. 5731356 Pharmaceutical compositions of propofol and edetate Claim Types: Process	SEP 22,2015 *PED	U-218: Method for limiting the potential for microbial growth in the drug product
Pat. No. 5908869 Propofol compositions containing edetate Claim Types: Process	SEP 22,2015 *PED	U-270: Method of improving the time for administration or the time between changes of giving sets for the drug product

ANESTHETICS, GENERAL
SUPRANE (LIQUID) DESFLURANE
Drug Classes: ANESTHETICS, GENERAL
NDA Applicant: BAXTER HLTHCARE CORP      NDA No.: 020118  Prod. No.: 001 RX (99.9%)

Patents	Expiration	Patented Use
Pat. No. 4762856 [Extension length not available] Anesthetic composition and method of using the same Claim Types: Method of use	FEB 02,2007	U-67: Method of inducing anesthesia in a warm blooded animal
Pat. No. 5617906 DP* Container for anaesthetic agent Claim Types: Device	APR 08,2014

ANESTHETICS, GENERAL
ULTANE (LIQUID) SEVOFLURANE [GENERIC AN]
Drug Classes: ANESTHETICS, GENERAL
NDA Applicant: ABBOTT      NDA No.: 020478  Prod. No.: 001 RX (100%)

Patents	Expiration	Patented Use
Pat. No. 5990176 Fluoroether compositions and methods for inhibiting their degradation in the presence of a Lewis acid Claim Types: Formulation; Method of improving a formulation	JUL 27,2017 *PED
Pat. No. 6074668 Container for an inhalation anesthetic Claim Types: Drug in a container	JUL 09,2018 *PED
Pat. No. 6288127 Fluoroether compositions and methods for inhibiting their degradation in the presence of a Lewis acid Claim Types: Formulation; Method of improving a formulation	JUL 27,2017 *PED
Pat. No. 6444859 Fluoroether compositions and methods for inhibiting their degradation in the presence of a Lewis acid Claim Types: Method of improving a formulation; Product-by-process	JUL 27,2017 *PED

ANESTHETICS, LOCAL
CHIROCAINE (INJECTABLE) LEVOBUPIVACAINE HYDROCHLORIDE
Drug Classes: ANESTHETICS, LOCAL
NDA Applicant: PURDUE PHARMA LP      NDA No.: 020997  Prod. No.: 001 DISC (EQ 2.5MG BASE/ML); 002 DISC (EQ 5MG BASE/ML); 003 DISC (EQ 7.5MG BASE/ML)

Patents	Expiration	Patented Use
Pat. No. 5708011 Use of levobupivacaine in a patient having depressed myocardial contractility Claim Types: Method of use	OCT 13,2014	U-276: Method of use of levobupivacaine

ANESTHETICS, LOCAL
LIDOCAINE (FILM, EXTENDED RELEASE) LIDOCAINE
Drug Classes: ANESTHETICS, LOCAL
NDA Applicant: NOVEN      NDA No.: 020575  Prod. No.: 002 RX (46.1MG/PATCH) NDA No.: 020575  Prod. No.: 001 DISC (23MG/PATCH)

Patents	Expiration	Patented Use
Pat. No. 5234957 Compositions and methods for topical administration of pharmaceutically active agents Claim Types: Formulation	FEB 27,2011
Pat. No. 5332576 Compositions and methods for topical administration of pharmaceutically active agents Claim Types: Method of administration	JUL 26,2011
Pat. No. 5446070 Compositions and methods for topical administration of pharmaceutically active agents Claim Types: Device; Formulation	FEB 27,2011

ANESTHETICS, LOCAL
NAROPIN (INJECTABLE) ROPIVACAINE HYDROCHLORIDE MONOHYDRATE
Drug Classes: ANESTHETICS, LOCAL; ANTISEPTICS/DISINFECTANTS; ANTIASTHMATICS/BRONCODILATORS; PHARMACEUTICAL AIDS; SURGICAL AIDS
NDA Applicant: ABRAXIS BIOSCIENCE      NDA No.: 020533  Prod. No.: 001 RX (2MG/ML); 003 RX (5MG/ML); 004 RX (7.5MG/ML); 005 RX (10MG/ML)

Patents	Expiration	Patented Use
Pat. No. 4870086 [Extended 1400 days* (3.8 years)] Optically pure compound and a process for its preparation Claim Types: Compound; Process; Method of use	SEP 24,2010

ANESTHETICS, LOCAL
ORAQIX (GEL) LIDOCAINE; PRILOCAINE
Drug Classes: ANESTHETICS, LOCAL
NDA Applicant: DENTSPLY PHARM      NDA No.: 021451  Prod. No.: 001 RX (2.5%;2.5%)

Patents	Expiration	Patented Use
Pat. No. 6031007 DP* Pharmaceutical composition with anaesthetic effect Claim Types: Formulation; Method of use; Process	APR 01,2017	U-553: Management of pain and discomfort associated with peridontal scaling and root planning procedures by application of an eutectic mixture of local anesthetics to peridontal pockets
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NDF - New dosage form	DEC 19,2006

ANESTHETICS, TOPICAL
LIDODERM (PATCH) LIDOCAINE
Drug Classes: ANESTHETICS, TOPICAL
NDA Applicant: TEIKOKU PHARMA USA      NDA No.: 020612  Prod. No.: 001 RX (5%)

Patents	Expiration	Patented Use
Pat. No. 5411738 Method for treating nerve injury pain associated with shingles (herpes-zoster and post-herpetic neuralgia) by topical application of lidocaine Claim Types: Formulation; Method of use	MAY 02,2012
Pat. No. 5589180 Method for treating nerve injury pain associated with shingles (herpes-zoster and post-herpetic neuralgia) by topical application of lidocaine Claim Types: Formulation	MAR 17,2009	U-485: Method and composition for reducing nerve injury pain associated with Shingles (Herpes Zoster and Post-Herpetic Neuralgia)
Pat. No. 5601838 Method for treating pain associated with herpes-zoster and post-herpetic neuralgia Claim Types: Method of use	MAY 02,2012	U-488: Method for reducing the pain associated with Herpes-Zoster and Post-Herpetic Neuralgia
Pat. No. 5709869 Method for treating nerve injury pain associated with shingles Claim Types: Method of use	MAR 17,2009	U-485: Method and composition for reducing nerve injury pain associated with Shingles (Herpes Zoster and Post-Herpetic Neuralgia)
Pat. No. 5827529 External preparation for application to the skin containing lidocaine Claim Types: Formulation	OCT 27,2015	U-486: External preparation for application to the skin containing lidocaine-drug retaining layer placed on support and comprises adhesive gel base 1-10% by weight of lidocaine
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code ODE: Orphan Drug	MAR 19,2006	For relief of allodynia (painful hypersensitivity), and chronic pain in post-herpetic neuralgia.

ANOREXIANTS/CNS STIMULANTS
ADDERALL 10; ADDERALL 20; ADDERALL 5; ADDERALL 30; ADDERALL 7.5; ADDERALL 12.5; ADDERALL 15 (TABLET) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE [GENERIC AB]
Drug Classes: ANOREXIANTS/CNS STIMULANTS
NDA Applicant: SHIRE      NDA No.: 011522  Prod. No.: 007 RX (2.5MG;2.5MG;2.5MG;2.5MG); 008 RX (5MG;5MG;5MG;5MG); 009 RX (1.25MG;1.25MG;1.25MG;1.25MG); 010 RX (7.5MG;7.5MG;7.5MG;7.5MG); 011 RX (1.875MG;1.875MG;1.875MG;1.875MG); 012 RX (3.125MG;3.125MG;3.125MG;3.125MG); 013 RX (3.75MG;3.75MG;3.75MG;3.75MG)

Patents	Expiration	Patented Use
Pat. No. 6384020 Rapid immediate release oral dosage form Claim Types: Formulation	JAN 06,2021 *PED

ANOREXIANTS/CNS STIMULANTS
ADDERALL XR 10; ADDERALL XR 20; ADDERALL XR 30; ADDERALL XR 25; ADDERALL XR 5; ADDERALL XR 15 (CAPSULE, EXTENDED RELEASE) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Drug Classes: ANOREXIANTS/CNS STIMULANTS
NDA Applicant: SHIRE      NDA No.: 021303  Prod. No.: 001 RX (2.5MG;2.5MG;2.5MG;2.5MG); 002 RX (5MG;5MG;5MG;5MG); 003 RX (7.5MG;7.5MG;7.5MG;7.5MG); 004 RX (6.25MG;6.25MG;6.25MG;6.25MG); 005 RX (1.25MG;1.25MG;1.25MG;1.25MG); 006 RX (3.75MG;3.75MG;3.75MG;3.75MG)

Patents	Expiration	Patented Use
Pat. No. 6322819 Oral pulsed dose drug delivery system Claim Types: Formulation	APR 21,2019 *PED
Pat. No. 6605300 Oral pulsed dose drug delivery system Claim Types: Formulation	APR 21,2019 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NPP - New patient population	AUG 11,2007
Exclusivity Code: NPP - New patient population	Jan 21,2009 PED

ANOREXIANTS/CNS STIMULANTS
CAFCIT (SOLUTION) CAFFEINE CITRATE
Drug Classes: ANOREXIANTS/CNS STIMULANTS; ANTIASTHMATICS/BRONCODILATORS
NDA Applicant: MEAD JOHNSON      NDA No.: 020793  Prod. No.: 001 RX (EQ 30MG BASE/3ML (EQ 10MG BASE/ML))

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code ODE: Orphan Drug	SEP 21,2006	Treatment of apnea of prematurity.

ANOREXIANTS/CNS STIMULANTS
CONCERTA (TABLET, EXTENDED RELEASE) METHYLPHENIDATE HYDROCHLORIDE
Drug Classes: ANOREXIANTS/CNS STIMULANTS
NDA Applicant: ALZA      NDA No.: 021121  Prod. No.: 001 RX (18MG); 002 RX (36MG); 003 RX (54MG); 004 RX (27MG)

Patents	Expiration	Patented Use
Pat. No. 6919373 Methods and devices for providing prolonged drug therapy Claim Types: Method of use	JAN 31,2018 *PED	U-666: Method of treating ADHD
Pat. No. 6930129 Methods and devices for providing prolonged drug therapy Claim Types: Method of use	JAN 31,2018 *PED	U-666: Method of treating ADHD
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: D - New Dosing Schedule	Apr 21,2008 PED	D-94: New maximum dosage of 72 mg/day in adolescents 13-17 years of age with attention defecit hyperactivity disorder (ADHD)
Exclusivity Code: NPP - New patient population	Apr 21,2008 PED

ANOREXIANTS/CNS STIMULANTS
MERIDIA (CAPSULE) SIBUTRAMINE HYDROCHLORIDE
Drug Classes: ANOREXIANTS/CNS STIMULANTS; CNS, MISCELLANEOUS
NDA Applicant: ABBOTT      NDA No.: 020632  Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (15MG)

Patents	Expiration	Patented Use
Pat. No. 4746680 [Extended 5 years] Therapeutic agents Claim Types: Compound; Composition; Method of use	DEC 11,2007 *PED
Pat. No. 4929629 Therapeutic compound Claim Types: Compound; Composition; Method of use	NOV 29,2007 *PED
Pat. No. 5436272 Treatment of obesity Claim Types: Method of use	JAN 25,2013 *PED	U-439: Treatment of obesity

ANOREXIANTS/CNS STIMULANTS
METADATE CD (CAPSULE, EXTENDED RELEASE) METHYLPHENIDATE HYDROCHLORIDE
Drug Classes: ANOREXIANTS/CNS STIMULANTS
NDA Applicant: UCB INC      NDA No.: 021259  Prod. No.: 001 RX (20MG); 002 RX (30MG); 003 RX (10MG); 004 RX (40MG)

Patents	Expiration	Patented Use
Pat. No. 6344215 DP* Methylphenidate modified release formulations Claim Types: Formulation	OCT 27,2020

ANOREXIANTS/CNS STIMULANTS
RITALIN LA (CAPSULE, EXTENDED RELEASE) METHYLPHENIDATE HYDROCHLORIDE
Drug Classes: ANOREXIANTS/CNS STIMULANTS
NDA Applicant: NOVARTIS      NDA No.: 021284  Prod. No.: 001 RX (20MG); 002 RX (30MG); 003 RX (40MG)

Patents	Expiration	Patented Use
Pat. No. 5837284 DP* Delivery of multiple doses of medications Claim Types: Formulation	DEC 04,2015
Pat. No. 6228398 DP* Multiparticulate modified release composition Claim Types: Formulation; Method of use	NOV 01,2019	U-472: Treatment of attention deficit hyperactivity disorder using methylphenidate bi-modal release profile extended-release capsules
Pat. No. 6635284 DP* Delivery of multiple doses of medications Claim Types: Method of administration; Formulation	DEC 04,2015	U-591: Treatment of attention deficit hyperactivity disorder using a dosage form which provides once-daily oral administration of a phenidate drug

ANOREXIANTS/CNS STIMULANTS
RITALIN LA (CAPSULE, EXTENDED RELEASE) METHYLPHENIDATE HYDROCHLORIDE
Drug Classes: ANOREXIANTS/CNS STIMULANTS
NDA Applicant: NOVARTIS      NDA No.: 021284  Prod. No.: 004 RX (10MG)

Patents	Expiration	Patented Use
Pat. No. 5837284 DP* Delivery of multiple doses of medications Claim Types: Formulation	DEC 04,2015
Pat. No. 6228398 DP* Multiparticulate modified release composition Claim Types: Formulation; Method of use	NOV 01,2019
Pat. No. 6635284 DP* Delivery of multiple doses of medications Claim Types: Method of administration; Formulation	DEC 04,2015	U-591: Treatment of attention deficit hyperactivity disorder using a dosage form which provides once-daily oral administration of a phenidate drug

ANOREXIANTS/CNS STIMULANTS
XENICAL (CAPSULE) ORLISTAT
Drug Classes: ANOREXIANTS/CNS STIMULANTS
NDA Applicant: HLR      NDA No.: 020766  Prod. No.: 001 RX (120MG)

Patents	Expiration	Patented Use
Pat. No. 4598089 [Extended 5 years] Leucine derivatives Claim Types: Compound; Composition; Method of use	DEC 18,2009 *PED
Pat. No. 6004996 Tetrahydrolipstatin containing compositions Claim Types: Formulation	JUL 06,2018 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	Jun 12,2007 PED	M-29: Labeling changes to provide information in the management of obesity in adolescents aged 12 to 16 years

ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
GANIRELIX ACETATE INJECTION (INJECTABLE) GANIRELIX ACETATE
Drug Classes: ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION; INFERTILITY
NDA Applicant: ORGANON USA INC      NDA No.: 021057  Prod. No.: 001 RX (EQ 250UGM BASE/0.5ML)

Patents	Expiration	Patented Use
Pat. No. 4801577 DS* DP* [Extended 5 years] Nonapeptide and decapeptide analogs of LHRH useful as LHRH antagonists Claim Types: Compound; Composition	FEB 05,2012
Pat. No. 5767082 Nonapeptide and decapeptide analogs of LHRH useful as LHRH antagonists Claim Types: Method of use	JUN 16,2015

ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
GENOTROPIN PRESERVATIVE FREE (INJECTABLE) SOMATROPIN RECOMBINANT
Drug Classes: DRUGS USED IN DISORDERS OF GROWTH HORMONE SECRETION; ANTERIOR PITUITARY/HYPOTHALMIC FUNCTION
NDA Applicant: PHARMACIA AND UPJOHN      NDA No.: 020280  Prod. No.: 001 RX (0.2MG/VIAL); 002 RX (0.4MG/VIAL); 003 RX (0.6MG/VIAL); 005 RX (0.8MG/VIAL); 008 RX (1MG/VIAL); 009 RX (1.2MG/VIAL)

Patents	Expiration	Patented Use
Pat. No. 4968299 DP* Method and device for injection Claim Types: Device; Process	JUN 28,2008
Pat. No. 5435076 DP* Injection device Claim Types: Device; Process	APR 16,2013
Pat. No. 5716338 DP* Dual-chamber type injection cartridge with bypass connection Claim Types: Device	FEB 10,2015
Pat. No. 6152897 DP* Syringe Claim Types: Device	NOV 20,2018
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	APR 27,2009	I-496: Long term treatment of growth failure associated with Turner syndrome in patients who have open epiphyses
Exclusivity Code ODE: Orphan Drug	JUL 25,2008	Treatment of growth failure in children who were born small for gestational age.
Exclusivity Code ODE: Orphan Drug	JUN 20,2007	Treatment of short stature in patients with Prader-Willi syndrome.