ABACAVIR SULFATE (SOLUTION) ZIAGEN
Drug Classes: ANTIVIRALS
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 020978  Prod. No.: 001 RX (EQ 20MG BASE/ML)

Patents	Expiration	Patented Use
Pat. No. 5034394 [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. 5089500 Therapeutic nucleosides Claim Types: Method of use	DEC 26,2009 *PED	U-248: Treatment of HIV
Pat. No. 6294540 Carbocyclic nucleoside hemisulfate and its use in treating viral infections Claim Types: Composition; Method of use	NOV 14,2018 *PED	U-65: Method of treatment of a patient infected with HIV
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: D - New Dosing Schedule	AUG 02,2007	D-40: Once-a-day dosing regimen

ABACAVIR SULFATE; LAMIVUDINE (TABLET) EPZICOM
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

ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE (TABLET) TRIZIVIR
Drug Classes: ANTIVIRALS
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 021205  Prod. No.: 001 RX (EQ 300MG BASE;150MG;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	DEC 26,2009 *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-248: Treatment of HIV
Pat. No. 5089500 Therapeutic nucleosides Claim Types: Method of use	DEC 26,2009 *PED	U-248: Treatment of HIV
Pat. No. 5905082 DS* DP* Crystalline oxathiolane derivatives Claim Types: Composition; Method of use	NOV 18,2016 *PED	U-248: Treatment of HIV
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-65: Method of treatment of a patient infected with HIV
Pat. No. 6417191 DP* Synergistic combinations of zidovudine, 1592U89 and 3TC Claim Types: Method of use; Composition; Formulation	MAR 28,2016	U-248: Treatment of HIV

ABARELIX (INJECTABLE) PLENAXIS
NDA Applicant: PRAECIS      NDA No.: 021320  Prod. No.: 001 RX (100MG/VIAL)

Patents	Expiration	Patented Use
Pat. No. 5843901 DS* DP* LHRH antagonist peptides Claim Types: Compound; Composition	DEC 01,2015
Pat. No. 5968895 DP* Pharmaceutical formulations for sustained drug delivery Claim Types: Formulation	DEC 11,2016
Pat. No. 6180608 DP* Pharmaceutical formulations for sustained drug delivery Claim Types: Formulation; Kit; Device; Method of use	DEC 11,2016	U-549: Use in the treatment of men with advanced symptomatic prostate cancer
Pat. No. 6423686 DS* LHRH antagonist peptides Claim Types: Compound	JUN 07,2015
Pat. No. 6455499 Methods for treating disorders associated with LHRH activity Claim Types: Method of use	JUN 07,2015	U-549: Use in the treatment of men with advanced symptomatic prostate cancer
Pat. No. 6699833 DP* Pharmaceutical formulations for sustained drug delivery Claim Types: Formulation	DEC 11,2016
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	NOV 25,2008

ACAMPROSATE CALCIUM (TABLET, DELAYED RELEASE) CAMPRAL
NDA Applicant: FOREST LABS      NDA No.: 021431  Prod. No.: 001 RX (333MG)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	JUL 29,2009

ACARBOSE (TABLET) PRECOSE
Drug Classes: BLOOD GLUCOSE REGULATORS; DIURETICS
NDA Applicant: BAYER PHARMS      NDA No.: 020482  Prod. No.: 001 RX (50MG); 002 RX (100MG); 004 RX (25MG)

Patents	Expiration	Patented Use
Pat. No. 4904769 [Extended 922 days* (2.5 years)] Highly pure acarbose Claim Types: Formulation; Process Comments: Orange Book expiration date does not include extension. Extended expiration date is September 6, 2009.	FEB 27,2007

ACETAMINOPHEN (TABLET, EXTENDED RELEASE) TYLENOL (CAPLET) [GENERIC OTC]
NDA Applicant: MCNEIL CONS      NDA No.: 019872  Prod. No.: 001 OTC (650MG)

Patents	Expiration	Patented Use
Pat. No. 4820522 Oral sustained release acetaminophen formulation and process Claim Types: Formulation; Process	JUL 27,2007
Pat. No. 4968509 Oral sustained release acetaminophen formulation and process Claim Types: Formulation; Process	NOV 06,2007
Pat. No. 5004613 Oral sustained release pharmaceutical formulation and process Claim Types: Formulation; Process	JUL 27,2007

ACETAMINOPHEN; ASPIRIN; CAFFEINE (TABLET) EXCEDRIN (MIGRAINE) [GENERIC OTC]
NDA Applicant: NOVARTIS      NDA No.: 020802  Prod. No.: 001 OTC (250MG;250MG;65MG)

Patents	Expiration	Patented Use
Pat. No. 4943565 Analgesic tablet of aspirin and caffeine containing low-substituted hydroxypropyl cellulose Claim Types: Formulation	JUL 24,2007
Pat. No. 5972916 Compositions containing the nonprescription combination of acetaminophen, aspirin and caffeine to alleviate the pain and symptoms of migraine Claim Types: Method of use	JUL 14,2017	U-296: Treating migraine pain and one or more of a cluster of symptoms characteristic of a migraine attack symptoms being selected from photophobia, phonophobia, nausea and functional disability

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE (TABLET) ULTRACET [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

ACETYLCHOLINE CHLORIDE (FOR SOLUTION) MIOCHOL-E
Drug Classes: OPHTHALMICS, MISCELLANEOUS
NDA Applicant: NOVARTIS      NDA No.: 020213  Prod. No.: 001 RX (20MG/VIAL)

Patents	Expiration	Patented Use
Pat. No. 6261546 Methods and compositions for stabilizing acetylcholine compositions Claim Types: Device; Method of use; Process	APR 29,2019	U-506: Pharm product container 1st chamber is disposed aqueous diluent sol 2nd chamber pharm active agent comprising acetylcholine, buffer in 1st cham is sufficient to buffer pH of mixed sol resulting mixture of aqueous diluent sol & pharm active.

ACETYLCYSTEINE (INJECTABLE) ACETADOTE
NDA Applicant: CUMBERLAND PHARMS      NDA No.: 021539  Prod. No.: 001 RX (6GM/30ML (200MG/ML))

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code ODE: Orphan Drug	JAN 23,2011	For the intravenous treatment of moderate to severe acetaminophen overdose

ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE (CAPSULE) SEMPREX-D
Drug Classes: COLD REMEDIES
NDA Applicant: UCB INC      NDA No.: 019806  Prod. No.: 001 RX (8MG;60MG)

Patents	Expiration	Patented Use
Pat. No. 4650807 [Extended 1469 days (4 years)] Antihistaminic compositions and methods containing pyridine derivatives Claim Types: Composition; Method of use	MAR 26,2008	U-93: Use as an antihistamine/decongestant

ACYCLOVIR (CREAM) ZOVIRAX
Drug Classes: ANTIVIRALS
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 021478  Prod. No.: 001 RX (5%)

Patents	Expiration	Patented Use
Pat. No. 4963555 Formulations of heterocyclic compounds Claim Types: Formulation; Method of use	OCT 16,2007

ADAPALENE (SOLUTION) DIFFERIN
NDA Applicant: GALDERMA LABS LP      NDA No.: 020338  Prod. No.: 001 DISC (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

ADAPALENE (GEL) DIFFERIN
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

ADAPALENE (CREAM) DIFFERIN
NDA Applicant: GALDERMA LABS LP      NDA No.: 020748  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

ADEFOVIR DIPIVOXIL (TABLET) HEPSERA
NDA Applicant: GILEAD      NDA No.: 021449  Prod. No.: 001 RX (10MG)

Patents	Expiration	Patented Use
Pat. No. 4724233 Therapeutical application of phosphonylmethoxyalkyl adenines Claim Types: Method of use	APR 21,2006	U-470: Therapy in chronic hepatitis B virus infection
Pat. No. 4808716 9-(phosponylmethoxyalkyl) adenines, the method of preparation and utilization thereof Claim Types: Compound	APR 25,2006
Pat. No. 5663159 DS* DP* Prodrugs of phosphonates Claim Types: Compound; Method of use	SEP 02,2014	U-470: Therapy in chronic hepatitis B virus infection
Pat. No. 6451340 DS* DP* Nucleotide analog compositions Claim Types: New polymorph, salt or hydrate; Method of use; Process; Product-by-process; Formulation	JUL 23,2018	U-470: Therapy in chronic hepatitis B virus infection
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	SEP 20,2007

ADENOSINE (INJECTABLE) ADENOSCAN [Has competitive generic]
Drug Classes: ANTIARRHYTHMICS
NDA Applicant: ASTELLAS      NDA No.: 020059  Prod. No.: 001 RX (3MG/ML)

Patents	Expiration	Patented Use
Pat. No. 5070877 [Extended 159 days* (0.4 years)] Novel method of myocardial imaging Claim Types: Diagnostic or surgical method	MAY 18,2009	U-116: Method of myocardial imaging
Pat. No. 5731296 Selective vasodilation by continuous adenosine infusion Claim Types: Method of use	MAR 24,2015	U-221: Selective vasodilation by continuous adenosine infusion

ALATROFLOXACIN MESYLATE (INJECTABLE) TROVAN PRESERVATIVE FREE
NDA Applicant: PFIZER      NDA No.: 020760  Prod. No.: 001 DISC (EQ 200MG BASE/VIAL); 002 DISC (EQ 300MG BASE/VIAL)

Patents	Expiration	Patented Use
Pat. No. 5164402 [Extended 761 days* (2.1 years)] Azabicyclo quinolone and naphthyridinone carboxylic acids Claim Types: Compound; Composition; Method of use Comments: Orange Book expiration date for TROVAN PRESERVATIVE FREE does not include extension. Extended expiration date is December 18, 2011.	NOV 17,2009	U-282: Method of treating bacterial infections
Pat. No. 5763454 Crystal form of anhydrous 7-(ý1.alpha.,5.alpha.,6.alpha.!-6-amino-3-azabicycloý3.1.0! hex-3-yl)-6-fluoro-1-(2,4-difluorophenyl)-1,4-dihydro-4-oxo-1,8 naphthyridine-3-carboxylic acid, methanessulfonic acid salt Claim Types: New polymorph, salt or hydrate; Composition; Method of use	JUN 15,2015	U-282: Method of treating bacterial infections
Pat. No. 6080756 Polymorphs of the prodrug 6-N-(L-ALA-L-ALA)-trovafloxacin Claim Types: New polymorph, salt or hydrate; Method of use; Composition	JUL 05,2016
Pat. No. 6194429 Alatrofloxacin parenteral compositions Claim Types: Compound; Formulation; Process; Composition; Method of use	JUL 23,2018

ALBUMIN HUMAN (INJECTABLE) OPTISON
Drug Classes: BLOOD COMPONENTS/SUBSTITUTES
NDA Applicant: GE HEALTHCARE      NDA No.: 020899  Prod. No.: 001 RX (10MG/ML)

Patents	Expiration	Patented Use
Pat. No. 5529766 Contrast agents Claim Types: Diagnostic or surgical method; Formulation; Process	JUN 25,2013	U-505: Ultrasound contrast agent
Pat. No. 5558094 Methods for using persistent gases as ultrasound contrast media Claim Types: Diagnostic or surgical method	FEB 28,2012	U-505: Ultrasound contrast agent
Pat. No. 5573751 Persistent gaseous bubbles as ultrasound contrast media Claim Types: Composition; Formulation	APR 25,2012
Pat. No. 6723303 DP* Ultrasound contrast agents including protein stabilized microspheres of perfluoropropane, perfluorobutane or perfluoropentane Claim Types: Composition	APR 20,2021

ALBUTEROL SULFATE (AEROSOL, METERED) PROVENTIL-HFA
Drug Classes: ANTIASTHMATICS/BRONCODILATORS
NDA Applicant: 3M      NDA No.: 020503  Prod. No.: 001 RX (EQ 0.09MG BASE/INH)

Patents	Expiration	Patented Use
Pat. No. 5225183 Medicinal aerosol formulations Claim Types: Formulation	JUL 06,2010
Pat. No. 5439670 Medicinal aerosol formulations Claim Types: Formulation	JUL 06,2010
Pat. No. 5605674 Medicinal aerosol formulations Claim Types: Formulation	FEB 25,2014
Pat. No. 5695743 Medicinal aerosol formulations Claim Types: Formulation; Method of administration; Method of use	JUL 06,2010	U-491: Method of delivering a drug to the lung
Pat. No. 5766573 Medicinal aerosol formulations Claim Types: Method of administration	JUN 16,2015
Pat. No. 6352684 CRC-free medicinal aerosol formulations of 1,1,1,2-tetrafluoroethane (134A) with polar adjuvant Claim Types: Formulation	NOV 28,2009

ALBUTEROL SULFATE (SOLUTION) ACCUNEB [GENERIC AN]
Drug Classes: ANTIASTHMATICS/BRONCODILATORS
NDA Applicant: DEY      NDA No.: 020949  Prod. No.: 001 RX (EQ 0.042% BASE); 002 RX (EQ 0.021% BASE)

Patents	Expiration	Patented Use
Pat. No. 6702997 Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma Claim Types: Method of use	DEC 28,2021	U-558: Indicated for the relief of bronchospasm in patients 2-12 years of age with asthma (reversible obstructive airway disease)

ALBUTEROL SULFATE (AEROSOL, METERED) VENTOLIN HFA
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 020983  Prod. No.: 001 RX (EQ 0.09MG BASE/INH)

Patents	Expiration	Patented Use
Pat. No. 6131566 DP* Metered dose inhaler for albuterol Claim Types: Device; Method of administration	APR 14,2015	U-589: Method for treatment of a respiratory disorder, e.g., bronchospasm, comprising administering an effective amount of an aerosol composition to a patient from a metered dose inhaler system as claimed in U.S. Patent No. 6131966
Pat. No. 6131566 DP* Metered dose inhaler for albuterol Claim Types: Device; Method of administration	APR 14,2015	U-716: The treatment or prevention of bronchospasm in adults and children 4 years of age and older with reversible obstructive airways disease and the prevention of exercised-induced bronchospasm in patients 4 years of age and 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. 6532955 DP* Metered dose inhaler for albuterol Claim Types: Device; Method of administration	APR 14,2015	U-590: Method for treatment of a respiratory disorder,e.g.,bronchospasm,comprising administering to a patient by oral or nasal inhalation a drug formulation by using the metered dose inhaler system as claimed in U.S. Patent No.6532955
Pat. No. 6532955 DP* Metered dose inhaler for albuterol Claim Types: Device; Method of administration	APR 14,2015	U-716: The treatment or prevention of bronchospasm in adults and children 4 years of age and older with reversible obstructive airways disease and the prevention of exercised-induced bronchospasm in patients 4 years of age and older

ALBUTEROL SULFATE (AEROSOL, METERED) PROAIR HFA
NDA Applicant: IVAX RES      NDA No.: 021457  Prod. No.: 001 RX (EQ 0.09MG BASE/INH)

Patents	Expiration	Patented Use
Pat. No. 5605674 DP* Medicinal aerosol formulations Claim Types: Formulation	FEB 25,2014
Pat. No. 5695743 DP* Medicinal aerosol formulations Claim Types: Formulation; Method of administration; Method of use	JUL 06,2010	U-491: Method of delivering a drug to the lung
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. 6352684 DP* CRC-free medicinal aerosol formulations of 1,1,1,2-tetrafluoroethane (134A) with polar adjuvant Claim Types: Formulation	NOV 28,2009
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	FEB 03,2009	I-235: Prevention of exercise-induced bronchospasm in patients 12 years of age and older
Exclusivity Code: NP - New product	OCT 29,2007

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE (AEROSOL, METERED) COMBIVENT
Drug Classes: ANTIASTHMATICS/BRONCODILATORS
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 020291  Prod. No.: 001 RX (EQ 0.09MG BASE/INH;0.018MG/INH)

Patents	Expiration	Patented Use
Pat. No. 5603918 Aerosol composition of a salt of ipratropium and a salt of albuterol Claim Types: Formulation; Process	JUN 09,2015

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE (SOLUTION) DUONEB
Drug Classes: ANTIASTHMATICS/BRONCODILATORS
NDA Applicant: DEY      NDA No.: 020950  Prod. No.: 001 RX (EQ 0.083% BASE;0.017%)

Patents	Expiration	Patented Use
Pat. No. 6632842 Albuterol and ipratropium inhalation solution, system, kit and method for relieving symptoms of chronic obstructive pulmonary disease Claim Types: Method of improving a treatment	DEC 28,2021	U-532: Treatment of bronchospasm associated with COPD in patients requiring more than one broncho dilator

ALCOHOL; CHLORHEXIDINE GLUCONATE (SOLUTION) AVAGARD
NDA Applicant: 3M      NDA No.: 021074  Prod. No.: 001 OTC (61%;1%)

Patents	Expiration	Patented Use
Pat. No. 5897031 Dispenser for antimicrobial liquids Claim Types: Device; Method of using a device	JUN 21,2016

ALENDRONATE SODIUM (TABLET) FOSAMAX
Drug Classes: CALCIUM METABOLISM
NDA Applicant: MERCK      NDA No.: 020560  Prod. No.: 001 RX (EQ 10MG BASE)

Patents	Expiration	Patented Use
Pat. No. 4621077 [Extended 1371 days (3.8 years)] Pharmacologically active biphosphonates, process for the preparation thereof and pharmaceutical compositions therefrom Claim Types: Method of use	FEB 06,2008 *PED	U-114: Use for inhibiting bone resorption
Pat. No. 5358941 Dry mix formulation for bisphosphonic acids with lactose Claim Types: Formulation	JUN 02,2013 *PED
Pat. No. 5681590 Dry mix formulation for bisphosphonic acids Claim Types: Formulation; Process	JUN 02,2013 *PED
Pat. No. 5849726 Anhydrous alendronate monosodium salt formulations Claim Types: Composition; Method of use	DEC 06,2015 *PED
Pat. No. 6008207 Anhydrous alendronate monosodium salt formulations Claim Types: Method of use	DEC 06,2015 *PED	U-303: Method of use patent-product approved for treatment of osteoporosis, Paget's disease, prevention and treatment of glucocorticoid-induced osteoporosis
Pat. No. 6090410 Dry mix formulation for bisphosphonic acids Claim Types: Formulation	JUN 02,2013 *PED
Pat. No. 6194004 Dry mix formulation for bisphosphonic acids Claim Types: Formulation	JUN 02,2013 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	DEC 21,2008	M-51: Information added to labeling regarding osteogenesis imperfecta study

ALENDRONATE SODIUM (TABLET) FOSAMAX
Drug Classes: CALCIUM METABOLISM
NDA Applicant: MERCK      NDA No.: 020560  Prod. No.: 002 RX (EQ 40MG BASE)

Patents	Expiration	Patented Use
Pat. No. 4621077 [Extended 1371 days (3.8 years)] Pharmacologically active biphosphonates, process for the preparation thereof and pharmaceutical compositions therefrom Claim Types: Method of use	FEB 06,2008 *PED	U-114: Use for inhibiting bone resorption
Pat. No. 5358941 Dry mix formulation for bisphosphonic acids with lactose Claim Types: Formulation	JUN 02,2013 *PED
Pat. No. 5681590 Dry mix formulation for bisphosphonic acids Claim Types: Formulation; Process	JUN 02,2013 *PED
Pat. No. 5849726 Anhydrous alendronate monosodium salt formulations Claim Types: Composition; Method of use	DEC 06,2015 *PED
Pat. No. 6008207 Anhydrous alendronate monosodium salt formulations Claim Types: Method of use	JUN 06,2015 *PED	U-303: Method of use patent-product approved for treatment of osteoporosis, Paget's disease, prevention and treatment of glucocorticoid-induced osteoporosis
Pat. No. 6090410 Dry mix formulation for bisphosphonic acids Claim Types: Formulation	JUN 02,2013 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	DEC 21,2008	M-51: Information added to labeling regarding osteogenesis imperfecta study

ALENDRONATE SODIUM (TABLET) FOSAMAX
Drug Classes: CALCIUM METABOLISM
NDA Applicant: MERCK      NDA No.: 020560  Prod. No.: 003 RX (EQ 5MG BASE)

Patents	Expiration	Patented Use
Pat. No. 4621077 [Extended 1371 days (3.8 years)] Pharmacologically active biphosphonates, process for the preparation thereof and pharmaceutical compositions therefrom Claim Types: Method of use	FEB 06,2008 *PED	U-114: Use for inhibiting bone resorption
Pat. No. 5358941 Dry mix formulation for bisphosphonic acids with lactose Claim Types: Formulation	JUN 02,2013 *PED
Pat. No. 5681590 Dry mix formulation for bisphosphonic acids Claim Types: Formulation; Process	JUN 02,2013 *PED
Pat. No. 5849726 Anhydrous alendronate monosodium salt formulations Claim Types: Composition; Method of use	DEC 06,2015 *PED
Pat. No. 6008207 Anhydrous alendronate monosodium salt formulations Claim Types: Method of use	DEC 06,2015 *PED	U-303: Method of use patent-product approved for treatment of osteoporosis, Paget's disease, prevention and treatment of glucocorticoid-induced osteoporosis
Pat. No. 6090410 Dry mix formulation for bisphosphonic acids Claim Types: Formulation	JUN 02,2013 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	DEC 21,2008	M-51: Information added to labeling regarding osteogenesis imperfecta study

ALENDRONATE SODIUM (TABLET) FOSAMAX
Drug Classes: CALCIUM METABOLISM
NDA Applicant: MERCK      NDA No.: 020560  Prod. No.: 004 RX (EQ 35MG BASE)

Patents	Expiration	Patented Use
Pat. No. 4621077 [Extended 1371 days (3.8 years)] Pharmacologically active biphosphonates, process for the preparation thereof and pharmaceutical compositions therefrom Claim Types: Method of use	FEB 06,2008 *PED	U-114: Use for inhibiting bone resorption
Pat. No. 5358941 Dry mix formulation for bisphosphonic acids with lactose Claim Types: Formulation	JUN 02,2013 *PED
Pat. No. 5681590 Dry mix formulation for bisphosphonic acids Claim Types: Formulation; Process	JUN 02,2013 *PED
Pat. No. 5849726 Anhydrous alendronate monosodium salt formulations Claim Types: Composition; Method of use	DEC 16,2015 *PED
Pat. No. 5994329 Method for inhibiting bone resorption Claim Types: Method of use; Kit	JAN 17,2019 *PED
Pat. No. 6008207 Anhydrous alendronate monosodium salt formulations Claim Types: Method of use	DEC 06,2015 *PED
Pat. No. 6015801 Method for inhibiting bone resorption Claim Types: Method of use	JAN 17,2019 *PED	U-353: Prevention and treatment of osteoporosis
Pat. No. 6090410 Dry mix formulation for bisphosphonic acids Claim Types: Formulation	JUN 02,2013 *PED
Pat. No. 6225294 Method for inhibiting bone resorption Claim Types: Kit	JAN 17,2019 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	DEC 21,2008	M-51: Information added to labeling regarding osteogenesis imperfecta study

ALENDRONATE SODIUM (TABLET) FOSAMAX
Drug Classes: CALCIUM METABOLISM
NDA Applicant: MERCK      NDA No.: 020560  Prod. No.: 005 RX (EQ 70MG BASE)

Patents	Expiration	Patented Use
Pat. No. 4621077 [Extended 1371 days (3.8 years)] Pharmacologically active biphosphonates, process for the preparation thereof and pharmaceutical compositions therefrom Claim Types: Method of use	FEB 06,2008 *PED	U-114: Use for inhibiting bone resorption
Pat. No. 5358941 Dry mix formulation for bisphosphonic acids with lactose Claim Types: Formulation	JUN 02,2013 *PED
Pat. No. 5681590 Dry mix formulation for bisphosphonic acids Claim Types: Formulation; Process	JUN 02,2013 *PED
Pat. No. 5849726 Anhydrous alendronate monosodium salt formulations Claim Types: Composition; Method of use	DEC 06,2015 *PED
Pat. No. 5994329 Method for inhibiting bone resorption Claim Types: Method of use; Kit	JAN 17,2019 *PED
Pat. No. 6008207 Anhydrous alendronate monosodium salt formulations Claim Types: Method of use	DEC 06,2015 *PED
Pat. No. 6015801 Method for inhibiting bone resorption Claim Types: Method of use	JAN 17,2019 *PED	U-353: Prevention and treatment of osteoporosis
Pat. No. 6090410 Dry mix formulation for bisphosphonic acids Claim Types: Formulation	JUN 02,2013 *PED
Pat. No. 6225294 Method for inhibiting bone resorption Claim Types: Kit	JAN 17,2019 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: D - New Dosing Schedule	APR 16,2007	D-87: Addition of once-weekly dosing for the treatment to increase bone mass in men with osteoporosis
Exclusivity Code: M - Miscellaneous	DEC 21,2008	M-51: Information added to labeling regarding osteogenesis imperfecta study

ALENDRONATE SODIUM (SOLUTION) FOSAMAX
NDA Applicant: MERCK      NDA No.: 021575  Prod. No.: 001 RX (EQ 70MG BASE/75ML)

Patents	Expiration	Patented Use
Pat. No. 4621077 [Extended 1371 days (3.8 years)] Pharmacologically active biphosphonates, process for the preparation thereof and pharmaceutical compositions therefrom Claim Types: Method of use	FEB 06,2008 *PED
Pat. No. 5462932 Oral liquid alendronate formulations Claim Types: Formulation; Method of use	MAY 17,2014
Pat. No. 5994329 Method for inhibiting bone resorption Claim Types: Method of use; Kit	JAN 17,2019 *PED
Pat. No. 6015801 Method for inhibiting bone resorption Claim Types: Method of use	JAN 17,2019 *PED
Pat. No. 6225294 Method for inhibiting bone resorption Claim Types: Kit	JAN 17,2019 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: D - New Dosing Schedule	APR 16,2007	D-87: Addition of once-weekly dosing for the treatment to increase bone mass in men with osteoporosis
Exclusivity Code: M - Miscellaneous	DEC 21,2008	M-51: Information added to labeling regarding osteogenesis imperfecta study

ALENDRONATE SODIUM; CHOLECALCIFEROL (TABLET) FOSAMAX PLUS D
NDA Applicant: MERCK      NDA No.: 021762  Prod. No.: 001 RX (EQ 70MG BASE;2,800 IU)

Patents	Expiration	Patented Use
Pat. No. 4621077 [Extended 1371 days (3.8 years)] Pharmacologically active biphosphonates, process for the preparation thereof and pharmaceutical compositions therefrom Claim Types: Method of use	FEB 06,2008 *PED	U-648: The treatment of osteoporosis in postmenopausal women and/or the treatment to increase bone mass in men
Pat. No. 5358941 DP* Dry mix formulation for bisphosphonic acids with lactose Claim Types: Formulation	JUN 02,2013 *PED
Pat. No. 5681590 DP* Dry mix formulation for bisphosphonic acids Claim Types: Formulation; Process	JUN 02,2013 *PED
Pat. No. 5994329 Method for inhibiting bone resorption Claim Types: Method of use; Kit	JAN 17,2019 *PED	U-647: Treatment of osteoporosis in post menopausal women and/or the treatment to increase bone mass in men with osteoporosis
Pat. No. 6090410 DP* Dry mix formulation for bisphosphonic acids Claim Types: Formulation	JUN 02,2013 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NC - New combination	APR 07,2008

ALFUZOSIN HYDROCHLORIDE (TABLET, EXTENDED RELEASE) UROXATRAL
NDA Applicant: SANOFI AVENTIS US      NDA No.: 021287  Prod. No.: 001 RX (10MG)

Patents	Expiration	Patented Use
Pat. No. 4661491 [Extension length not available] Alfuzosine compositions and use Claim Types: Method of use	MAY 27,2007	U-706: Treatment of benign prostatic hyperplasia
Pat. No. 6149940 Tablet with controlled release of alfuzosine chlorhydrate Claim Types: Formulation	AUG 22,2017
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	JUN 12,2008

ALITRETINOIN (GEL) PANRETIN
Drug Classes: DERMATOLOGICS
NDA Applicant: LIGAND      NDA No.: 020886  Prod. No.: 001 RX (EQ 0.1% BASE)

Patents	Expiration	Patented Use
Pat. No. 5932622 Method for in vivo modulation of non-malignant skin-related processes with 9-cis-retinoic acid Claim Types: Method of use	AUG 03,2016	U-562: Topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's Sarcoma
Pat. No. 7056954 DP* Means for the modulation of processes mediated by retinoid receptors and compounds useful therefor Claim Types: Formulation	AUG 02,2012
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code ODE: Orphan Drug	FEB 02,2006	Topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma.

ALMOTRIPTAN MALATE (TABLET) AXERT
NDA Applicant: ORTHO MCNEIL PHARM      NDA No.: 021001  Prod. No.: 001 RX (EQ 6.25MG BASE); 002 RX (EQ 12.5MG BASE)

Patents	Expiration	Patented Use
Pat. No. 5565447 [Extended 569 days (1.6 years)] Indole derivatives Claim Types: Compound; Method of use Comments: This patent was extended under Sec. 156; expiration date includes the extension	MAY 07,2015
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	MAY 07,2006

ALOSETRON HYDROCHLORIDE (TABLET) LOTRONEX
Drug Classes: DISORDERS, ACID/PEPTIC; GASTROINTESTINAL, MISCELLANEOUS
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 021107  Prod. No.: 001 RX (EQ 1MG BASE); 002 RX (EQ 0.5MG BASE)

Patents	Expiration	Patented Use
Pat. No. 5360800 DS* DP* Tetrahydro-1H-pyrido[4,3-b]indol-1-one derivatives Claim Types: Compound; Composition; Method of use	JAN 13,2013	U-405: For women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS)

ALPRAZOLAM (TABLET) XANAX [GENERIC AB]
Drug Classes: ANTIANXIETY; SEDATIVES/HYPNOTICS
NDA Applicant: PHARMACIA AND UPJOHN      NDA No.: 018276  Prod. No.: 004 RX (2MG)

Patents	Expiration	Patented Use
Pat. No. 5061494 Tri-scored drug tablet Claim Types: Functional tablet design	DEC 12,2008

ALPRAZOLAM (TABLET, EXTENDED RELEASE) XANAX XR [GENERIC AB]
Drug Classes: ANTIANXIETY
NDA Applicant: PHARMACIA AND UPJOHN      NDA No.: 021434  Prod. No.: 001 RX (0.5MG); 002 RX (1MG); 003 RX (2MG); 004 RX (3MG)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NDF - New dosage form	JAN 17,2006

ALPRAZOLAM (TABLET, ORALLY DISINTEGRATING) NIRAVAM
NDA Applicant: SCHWARZ PHARMA      NDA No.: 021726  Prod. No.: 001 RX (0.25MG); 002 RX (0.5MG); 003 RX (1MG); 004 RX (2MG)

Patents	Expiration	Patented Use
Pat. No. 6024981 DP* Rapidly dissolving robust dosage form Claim Types: Formulation; Process; Drug in a container	APR 09,2018
Pat. No. 6221392 DP* Rapidly dissolving robust dosage form Claim Types: Formulation	APR 09,2018

ALPROSTADIL (INJECTABLE) CAVERJECT
Drug Classes: PHARMACEUTICAL AIDS; CORONARY VASODILATORS
NDA Applicant: PHARMACIA AND UPJOHN      NDA No.: 020379  Prod. No.: 001 RX (0.01MG/VIAL); 002 RX (0.02MG/VIAL); 003 RX (0.005MG/VIAL); 004 RX (0.04MG/VIAL)

Patents	Expiration	Patented Use
Pat. No. 5741523 Stabilized prostaglandin E1 Claim Types: Product-by-process	APR 21,2015

ALPROSTADIL (SUPPOSITORY) MUSE
NDA Applicant: VIVUS      NDA No.: 020700  Prod. No.: 001 RX (0.125MG); 002 RX (0.25MG); 003 RX (0.5MG); 004 RX (1MG)

Patents	Expiration	Patented Use
Pat. No. 4801587 Impotence ointment Claim Types: Method of use	JAN 31,2007	U-155: Treatment of erectile dysfunction
Pat. No. 5242391 Urethral insert for treatment of erectile dysfunction Claim Types: Device	SEP 07,2010	U-155: Treatment of erectile dysfunction
Pat. No. 5474535 Dosage and inserter for treatment of erectile dysfunction Claim Types: Device	DEC 12,2012	U-155: Treatment of erectile dysfunction

AMIFOSTINE (INJECTABLE) ETHYOL
Drug Classes: ANTIDOTES, SPECIFIC
NDA Applicant: MEDIMMUNE ONCOLOGY      NDA No.: 020221  Prod. No.: 001 RX (500MG/VIAL) NDA No.: 020221  Prod. No.: 002 DISC (375MG/VIAL)

Patents	Expiration	Patented Use
Pat. No. 5424471 Crystalline amifostine compositions and methods of the preparation and use of same Claim Types: Product-by-process; Process	JUL 31,2012
Pat. No. 5591731 Crystalline amifostine compositions Claim Types: Composition	JUL 31,2012
Pat. No. 5994409 Methods for treatment of neuro--and nephro--disorders and therapeutic toxicities using aminothiol compounds Claim Types: Method of use	DEC 08,2017	U-305: Methods for using the drug product
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code ODE: Orphan Drug	JUN 24,2006	Reduction of the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer.

AMINOLEVULINIC ACID HYDROCHLORIDE (SOLUTION) LEVULAN
NDA Applicant: DUSA      NDA No.: 020965  Prod. No.: 001 RX (20%)

Patents	Expiration	Patented Use
Pat. No. 5079262 [Extended 1525 days (4.2 years)] Method of detection and treatment of malignant and non-malignant lesions utilizing 5-aminolevulinic acid Claim Types: Method of use	JUL 28,2009	U-289: Treatment of non-hyperkeratotic actinic keratoses of face and scalp
Pat. No. 5211938 Method of detection of malignant and non-malignant lesions by photochemotherapy of protoporphyrin IX percursors Claim Types: Diagnostic or surgical method	MAY 18,2010	U-289: Treatment of non-hyperkeratotic actinic keratoses of face and scalp
Pat. No. 5422093 Photochemotherapeutic method using 5-aminolevulinic acid and precursors thereof Claim Types: Method of use	JUL 28,2009	U-289: Treatment of non-hyperkeratotic actinic keratoses of face and scalp
Pat. No. 5954703 Method and apparatus for applying 5-aminolevulinic acid Claim Types: Method of administration; Device	OCT 31,2017	U-289: Treatment of non-hyperkeratotic actinic keratoses of face and scalp
Pat. No. 6710066 Photochemotherapeutic method using 5-aminolevulinic acid and other precursors of endogenous porphyrins Claim Types: Method of use	JUL 28,2009	U-289: Treatment of non-hyperkeratotic actinic keratoses of face and scalp

AMLEXANOX (PASTE) APHTHASOL
Drug Classes: DENTAL PREPARATIONS
NDA Applicant: ULURU      NDA No.: 020511  Prod. No.: 001 RX (5%)

Patents	Expiration	Patented Use
Pat. No. 5362737 Methods of treating aphthous ulcers and other mucocutaneous disorders with amlexanox Claim Types: Method of use	NOV 08,2011	U-243: Topical administration

AMLEXANOX (PATCH) AMLEXANOX
NDA Applicant: ULURU      NDA No.: 021727  Prod. No.: 001 RX (2MG)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NDF - New dosage form	SEP 29,2007

AMLODIPINE BESYLATE (TABLET) NORVASC [GENERIC AB]
Drug Classes: CALCIUM CHANNEL BLOCKERS; ANTIHYPERTENSIVES
NDA Applicant: PFIZER      NDA No.: 019787  Prod. No.: 001 RX (EQ 2.5MG BASE); 002 RX (EQ 5MG BASE); 003 RX (EQ 10MG 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-683: Prevention or treatment of ischemic heart disease
Pat. No. 4879303 DS* DP* Pharmaceutically acceptable salts Claim Types: Compound;Composition; Formulation	SEP 25,2007 *PED
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	SEP 28,2008	I-472: Use in patients with angiographically documented coronary artery disease
Exclusivity Code: NPP - New patient population	Jul 08,2007 PED

AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM (TABLET) CADUET
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

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE (CAPSULE) LOTREL
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

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE (CAPSULE) LOTREL
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

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE (TABLET) ADDERALL 10; ADDERALL 20; ADDERALL 5; ADDERALL 30; ADDERALL 7.5; ADDERALL 12.5; ADDERALL 15 [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

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE (CAPSULE, EXTENDED RELEASE) ADDERALL XR 10; ADDERALL XR 20; ADDERALL XR 30; ADDERALL XR 25; ADDERALL XR 5; ADDERALL XR 15
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

AMPRENAVIR (CAPSULE) AGENERASE
Drug Classes: ANTIVIRALS
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 021007  Prod. No.: 001 RX (50MG) NDA No.: 021007  Prod. No.: 002 DISC (150MG)

Patents	Expiration	Patented Use
Pat. No. 5585397 Sulfonamide inhibitors of aspartyl protease Claim Types: Compound; Composition	DEC 17,2013
Pat. No. 5646180 Treatment of the CNS effects of HIV Claim Types: Method of use	JUL 08,2014	U-257: Treatment of HIV infection
Pat. No. 5723490 THF-containing sulfonamide inhibitors of aspartyl protease Claim Types: Composition; Method of use	MAR 03,2015	U-257: Treatment of HIV infection
Pat. No. 6730679 DP* Pharmaceutical formulations Claim Types: Formulation	NOV 11,2017

AMPRENAVIR (SOLUTION) AGENERASE
Drug Classes: ANTIVIRALS
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 021039  Prod. No.: 001 RX (15MG/ML)

Patents	Expiration	Patented Use
Pat. No. 5585397 Sulfonamide inhibitors of aspartyl protease Claim Types: Compound; Composition	DEC 17,2013
Pat. No. 5646180 Treatment of the CNS effects of HIV Claim Types: Method of use	JUL 08,2014	U-257: Treatment of HIV infection
Pat. No. 5723490 THF-containing sulfonamide inhibitors of aspartyl protease Claim Types: Composition; Method of use	MAR 03,2015	U-257: Treatment of HIV infection

ANAGRELIDE HYDROCHLORIDE (CAPSULE) AGRYLIN [GENERIC AB]
NDA Applicant: SHIRE      NDA No.: 020333  Prod. No.: 001 RX (EQ 0.5MG BASE); 002 RX (EQ 1MG BASE)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	Jun 10,2008 PED	M-39: For labeling changes based on results of the SPD422-202 clinical study report (CSR) submitted in response to the written request

ANASTROZOLE (TABLET) ARIMIDEX
Drug Classes: ANTINEOPLASTICS
NDA Applicant: ASTRAZENECA      NDA No.: 020541  Prod. No.: 001 RX (1MG)

Patents	Expiration	Patented Use
Pat. No. RE36617 (Substituted aralkyl) heterocyclic compounds Claim Types: Compound; Composition; Method of use	DEC 27,2009

ANIDULAFUNGIN (INJECTABLE) ERAXIS
NDA Applicant: VICURON      NDA No.: 021632  Prod. No.: 001 RX (50MG/VIAL)

Patents	Expiration	Patented Use
Pat. No. 5965525 DS* DP* Cyclic peptide antifungal agents Claim Types: Compound; Method of use; Composition	OCT 12,2016	U-540: Treatment of fungal infections
Pat. No. 6384013 DS* Cyclic peptide antifungal agents and process for preparation thereof Claim Types: Compound	MAR 19,2012
Pat. No. 6743777 DP* Cyclic peptide antifungal agents and process for preparation thereof Claim Types: Composition; Method of use	MAR 19,2012	U-540: Treatment of fungal infections
Pat. No. 6960564 DP* Echinocandin pharmaceutical formulations containing micelle-forming surfactants Claim Types: Formulation; Process; Method of use	APR 12,2021	U-540: Treatment of fungal infections
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	FEB 17,2011

APOMORPHINE HYDROCHLORIDE (INJECTABLE) APOKYN
NDA Applicant: VERNALIS      NDA No.: 021264  Prod. No.: 001 RX (20MG/2ML (10MG/ML)); 002 RX (30MG/3ML (10MG/ML))

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	APR 20,2009
Exclusivity Code ODE: Orphan Drug	APR 20,2011	Treatment of the on-off fluctuations associated with late-stage Parkinson's disease.

APRACLONIDINE HYDROCHLORIDE (SOLUTION/DROPS) IOPIDINE
Drug Classes: OPHTHALMICS, MISCELLANEOUS
NDA Applicant: ALCON      NDA No.: 019779  Prod. No.: 001 RX (EQ 1% BASE)

Patents	Expiration	Patented Use
Pat. No. 5212196 Control of post-surgical intraocular pressure using clonidine derivatives Claim Types: Method of use	MAY 18,2010	U-120: Controlling or preventing post-operative intraocular pressure rises associated with ophthalmic laser surgical procedures

APREPITANT (CAPSULE) EMEND
Drug Classes: ANTIEMETICS
NDA Applicant: MERCK      NDA No.: 021549  Prod. No.: 001 RX (80MG); 002 RX (125MG)

Patents	Expiration	Patented Use
Pat. No. 5145684 DP* Surface modified drug nanoparticles Claim Types: Composition; Method of use; Process	JAN 25,2011
Pat. No. 5538982 Medical use for tachykinin antagonists Claim Types: Method of use	JUL 23,2013	U-745: Treatment or prevention of emesis
Pat. No. 5719147 DS* DP* Morpholine and thiomorpholine tachykinin receptor antagonists Claim Types: Compound; Composition; Method of use; Process	JUN 29,2012
Pat. No. 6048859 Morpholine and thiomorpholine tachykinin receptor antagonists Claim Types: Method of use	JUN 29,2012	U-745: Treatment or prevention of emesis
Pat. No. 6096742 DS* DP* Polymorphic form of a tachykinin receptor antagonist Claim Types: New polymorph, salt or hydrate; Composition; Method of use	JUL 01,2018	U-745: Treatment or prevention of emesis
Pat. No. 6235735 Morpholine and thiomorpholine tachykinin receptor antagonists Claim Types: Method of use	JUN 29,2012	U-746: Prevention or treatment of nausea or emesis induced by a cancer chemotherapeutic agent
Pat. No. 6235735 Morpholine and thiomorpholine tachykinin receptor antagonists Claim Types: Method of use	JUN 29,2012	U-747: Prevention or treatment of post-operative nausea and vomiting
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	OCT 28,2008	I-475: Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy
Exclusivity Code: NCE - New chemical entity	MAR 26,2008

APREPITANT (CAPSULE) EMEND
Drug Classes: ANTIEMETICS
NDA Applicant: MERCK      NDA No.: 021549  Prod. No.: 003 RX (40MG)

Patents	Expiration	Patented Use
Pat. No. 5145684 DP* Surface modified drug nanoparticles Claim Types: Composition; Method of use; Process	JAN 25,2011
Pat. No. 5538982 Medical use for tachykinin antagonists Claim Types: Method of use	JUL 23,2013	U-745: Treatment or prevention of emesis
Pat. No. 5719147 DS* DP* Morpholine and thiomorpholine tachykinin receptor antagonists Claim Types: Compound; Composition; Method of use; Process	JUN 29,2012
Pat. No. 6048859 Morpholine and thiomorpholine tachykinin receptor antagonists Claim Types: Method of use	JUN 29,2012	U-745: Treatment or prevention of emesis
Pat. No. 6096742 DS* DP* Polymorphic form of a tachykinin receptor antagonist Claim Types: New polymorph, salt or hydrate; Composition; Method of use	JUL 01,2018	U-745: Treatment or prevention of emesis
Pat. No. 6235735 Morpholine and thiomorpholine tachykinin receptor antagonists Claim Types: Method of use	JUN 29,2012	U-746: Prevention or treatment of nausea or emesis induced by a cancer chemotherapeutic agent
Pat. No. 6235735 Morpholine and thiomorpholine tachykinin receptor antagonists Claim Types: Method of use	JUN 29,2012	U-747: Prevention or treatment of post-operative nausea and vomiting
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	JUN 30,2009	I-498: Prevention of postoperative nausea and vomiting
Exclusivity Code: NCE - New chemical entity	MAR 26,2008
Exclusivity Code: NS - New strength	JUN 30,2009

ARBUTAMINE HYDROCHLORIDE (INJECTABLE) GENESA
NDA Applicant: GENSIA AUTOMEDICS      NDA No.: 020420  Prod. No.: 001 DISC (0.05MG/ML)

Patents	Expiration	Patented Use
Pat. No. 5108363 Diagnosis, evaluation and treatment of coronary artery disease by exercise simulation using closed loop drug delivery of an exercise simulating agent beta agonist Claim Types: Method of use	APR 28,2009	U-220: Method of diagnosis
Pat. No. 5234404 [Extended 398 days* (1.1 years)] Diagnosis, evaluation and treatment of coronary artery disease by exercise simulation using closed loop drug delivery of an exercise simulating agent beta agonist Claim Types: Diagnostic or surgical method Comments: Orange Book expiration date does not include extension. Extended expiration date is September 12, 2011.	AUG 10,2010	U-220: Method of diagnosis
Pat. No. 5395970 1-(3,4-dihydroxyphenyl)-2-(4-(4-hydroxyphenyl)butaylamino)ethanol Claim Types: Compound	MAR 07,2012

ARGATROBAN (INJECTABLE) ARGATROBAN
Drug Classes: ANTICOAGULANTS/THROMBOLYTICS
NDA Applicant: ENCYSIVE      NDA No.: 020883  Prod. No.: 001 RX (100MG/ML)

Patents	Expiration	Patented Use
Pat. No. 5214052 [Extended 1497 days (4.1 years)] Method for dissolving arginineamides and pharmaceutical compositions containing them Claim Types: Formulation; Process	JUN 30,2014

ARIPIPRAZOLE (TABLET) ABILIFY
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)

Patents	Expiration	Patented Use
Pat. No. 5006528 DS* DP* [Extended 5 years] Carbostyril derivatives Claim Types: Compound; Composition	OCT 20,2014
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	AUG 28,2006	I-401: Longer-term efficacy of aripiprazole in the treatment of schizophrenia
Exclusivity Code: I - New Indication	SEP 29,2007	I-437: Treatment of acute manic and mixed episodes associated with bipolar disorder
Exclusivity Code: I - New Indication	MAR 01,2008	I-488: Maintenance therapy in bipolar I disorder
Exclusivity Code: NCE - New chemical entity	NOV 15,2007

ARIPIPRAZOLE (SOLUTION) ABILIFY
NDA Applicant: OTSUKA      NDA No.: 021713  Prod. No.: 001 RX (1MG/ML)

Patents	Expiration	Patented Use
Pat. No. 5006528 DS* DP* [Extended 5 years] Carbostyril derivatives Claim Types: Compound; Composition	OCT 20,2014
Pat. No. 6977257 DS* DP* Aripiprazole oral solution Claim Types: Formulation	APR 24,2022
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	AUG 28,2006	I-401: Longer-term efficacy of aripiprazole in the treatment of schizophrenia
Exclusivity Code: I - New Indication	SEP 29,2007	I-437: Treatment of acute manic and mixed episodes associated with bipolar disorder
Exclusivity Code: I - New Indication	MAR 01,2008	I-488: Maintenance therapy in bipolar I disorder
Exclusivity Code: NCE - New chemical entity	NOV 15,2007

ARSENIC TRIOXIDE (INJECTABLE) TRISENOX
NDA Applicant: CEPHALON      NDA No.: 021248  Prod. No.: 001 RX (1MG/ML)

Patents	Expiration	Patented Use
Pat. No. 6723351 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol Claim Types: Method of use	NOV 10,2018	U-573: Treatment of acute promyelogenous leukemia (APL)
Pat. No. 6855339 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol Claim Types: Method of use	NOV 10,2018	U-617: Treatment of acute promyelogenous leukemia (APL)
Pat. No. 6861076 Process for producing arsenic trioxide formulations and methods for treating cancer using arsenic trioxide or melarsoprol Claim Types: Method of use	NOV 10,2018	U-617: Treatment of acute promyelogenous leukemia (APL)
Pat. No. 6884439 Process for producing arsenic trioxide formulations and methods for treatingcancer using arsenic trioxide or melarsoprol Claim Types: Method of use	NOV 10,2018	U-651: Treatment of acute promyelocytic leukemia (APL)
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code ODE: Orphan Drug	SEP 25,2007	Treatment of acute promyelocytic leukemia.

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE (INJECTABLE) SEPTOCAINE
NDA Applicant: DEPROCO      NDA No.: 022010  Prod. No.: 001 RX (4%;EQ 0.0085MG BASE/1.7ML(4%; EQ 0.005MG BASE/ML))

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	MAR 30,2009

ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E (INJECTABLE) M.V.I.-12 (WITHOUT VITAMIN K)
NDA Applicant: MAYNE PHARMA USA      NDA No.: 008809  Prod. No.: 006 RX (20MG/ML;0.006MG/ML;0.05UGM/ML;1.5MG/ML;0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code ODE: Orphan Drug	SEP 09,2011	Prevention of vitamin deficiency and thromboembolic complications in people receiving home parenteral nutrition and warfarin-type anticoagulant therapy.

ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE (FOR SOLUTION) MOVIPREP
NDA Applicant: NORGINE B V      NDA No.: 021881  Prod. No.: 001 RX (4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NP - New product	AUG 02,2009

ASPIRIN; DIPYRIDAMOLE (CAPSULE, EXTENDED RELEASE) AGGRENOX
Drug Classes: ANTICOAGULANTS/THROMBOLYTICS
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 020884  Prod. No.: 001 RX (25MG;200MG)

Patents	Expiration	Patented Use
Pat. No. 6015577 Pharmaceutical compositions containing dipyridamole or mopidamol and acetylsalicylic acid or the physiologically acceptable salts thereof, processes for preparing them and their use in treating clot formation Claim Types: Formulation; Method of use	JAN 18,2017	U-302: To reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis

ASPIRIN; PRAVASTATIN SODIUM (TABLET, TABLET) PRAVIGARD PAC (COPACKAGED)
Drug Classes: CARDIOVASCULAR-RENAL; HYPERLIPIDEMIA
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 021387  Prod. No.: 001 RX (81MG,N/A;N/A,20MG); 002 RX (81MG,N/A;N/A,40MG); 003 RX (81MG,N/A;N/A,80MG); 004 RX (325MG,N/A;N/A,20MG); 005 RX (325MG,N/A;N/A,40MG); 006 RX (325MG,N/A;N/A,80MG)

Patents	Expiration	Patented Use
Pat. No. 4346227 [Extended 1598 days (4.4 years)] ML-236B Derivatives and their preparation Claim Types: Compound	APR 20,2006 *PED
Pat. No. 5030447 Pharmaceutical compositions having good stability Claim Types: Formulation	JAN 09,2009 *PED
Pat. No. 5180589 Pravastatin pharmaceuatical compositions having good stability Claim Types: Formulation; Process	JAN 09,2009 *PED
Pat. No. 5622985 Method for preventing a second heart attack employing an HMG CoA reductase inhibitor Claim Types: Method of use	OCT 22,2014 *PED	U-335: Use of pravastatin sodium for secondary prevention of coronary events in men and women who have had a myocardial infarction and have normal cholesterol levels

ATAZANAVIR SULFATE (CAPSULE) REYATAZ
Drug Classes: ANTIVIRALS
NDA Applicant: BRISTOL MYERS SQUIBB      NDA No.: 021567  Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 150MG BASE); 003 RX (EQ 200MG BASE)

Patents	Expiration	Patented Use
Pat. No. 5849911 Antivirally active heterocyclic azahexane derivatives Claim Types: Compound; Composition; Method of use	APR 09,2017
Pat. No. 6087383 Bisulfate salt of HIV protease inhibitor Claim Types: Compound; Composition	DEC 21,2018
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: D - New Dosing Schedule	JUL 06,2007	D-89: Use of REYATAZ 300 mg/ritonavir 100 mg once daily for treatment in HIV-infected antiretroviral-experienced patients
Exclusivity Code: NCE - New chemical entity	JUN 20,2008

ATOMOXETINE HYDROCHLORIDE (CAPSULE) STRATTERA
Drug Classes: ANTIDEPRESSANTS
NDA Applicant: LILLY      NDA No.: 021411  Prod. No.: 002 RX (10MG); 003 RX (18MG); 004 RX (25MG); 005 RX (40MG); 006 RX (60MG); 007 RX (80MG); 008 RX (100MG) NDA No.: 021411  Prod. No.: 001 DISC (5MG)

Patents	Expiration	Patented Use
Pat. No. 5658590 Treatment of attention-deficit/hyperactivity disorder Claim Types: Method of use	MAY 26,2017 *PED	U-494: Treatment of Attention-Deficit Hyperactivity Disorder
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	May 26,2008 PED

ATORVASTATIN CALCIUM (TABLET) LIPITOR
Drug Classes: BLOOD GLUCOSE REGULATORS; HYPERLIPIDEMIA
NDA Applicant: PFIZER      NDA No.: 020702  Prod. No.: 001 RX (EQ 10MG BASE); 002 RX (EQ 20MG BASE); 003 RX (EQ 40MG BASE); 004 RX (EQ 80MG BASE)

Patents	Expiration	Patented Use
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. 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
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Apr 18,2006 PED	I-350: Treatment of heterozygous familial hypercholesterolemia in adolescent boys and girls at least one year postmenarchal, ages 10 to 17 years, with a recommended dosing range of 10 to 40mg once daily
Exclusivity Code: I - New Indication	JUL 30,2007	I-434: Prevention of cardiovascular disease in adult patients without clinically evident heart disease, but with multiple risk factors for coronary heart disease to reduce risk of MI and risk for revascularization procedures and angina
Exclusivity Code: I - New Indication	SEP 21,2008	I-471: Indicated to reduce the risk of myocardial infarction and stroke in patients with type 2 diabetes and without clinically evident coronary heart disease but with multiple risk factors for coronary heart disease
Exclusivity Code: M - Miscellaneous	JUL 30,2007	M-36: Addition of information to clinical studies regarding prevention of cardiovascular disease

ATOVAQUONE (TABLET) MEPRON
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 020259  Prod. No.: 001 DISC (250MG)

Patents	Expiration	Patented Use
Pat. No. 4981874 Medicaments Claim Types: Method of use	FEB 15,2010 *PED	U-69: Treatment of pneumocystis carinii infections
Pat. No. 5053432 Naphthoquinone derivatives Claim Types: Compound; Method of use; Composition	APR 01,2009 *PED

ATOVAQUONE (SUSPENSION) MEPRON
Drug Classes: ANTIPROTOZOALS
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 020500  Prod. No.: 001 RX (750MG/5ML)

Patents	Expiration	Patented Use
Pat. No. 4981874 Medicaments Claim Types: Method of use	FEB 15,2010 *PED	U-69: Treatment of pneumocystis carinii infections
Pat. No. 5053432 Naphthoquinone derivatives Claim Types: Compound; Method of use; Composition	APR 01,2009 *PED
Pat. No. 6649659 DS* DP* Atovaquone pharmaceutical compositions Claim Types: Formulation; Method of use	JAN 10,2017 *PED	U-69: Treatment of pneumocystis carinii infections
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code ODE: Orphan Drug	Jul 05,2006 PED

ATOVAQUONE; PROGUANIL HYDROCHLORIDE (TABLET) MALARONE
Drug Classes: ANTIMALARIALS
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 021078  Prod. No.: 001 RX (250MG;100MG)

Patents	Expiration	Patented Use
Pat. No. 5053432 Naphthoquinone derivatives Claim Types: Compound; Method of use; Composition	APR 01,2009 *PED
Pat. No. 6166046 Combination of atovaquone with proguanil for the treatment of protozoal infections Claim Types: Formulation	MAY 25,2014 *PED	U-406: Method of use of atovaquone and proguanil
Pat. No. 6291488 Preventing protozoal infections Claim Types: Method of use	MAY 25,2014 *PED	U-406: Method of use of atovaquone and proguanil