Generic names starting with "A"

Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, all expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Products tagged as [GENERIC] have had a generic equivalent approved for at least one strength of the product.


ABACAVIR SULFATE (TABLET) ZIAGEN
Drug Classes: ANTIVIRALS
NDA Applicant: GLAXOSMITHKLINE      NDA No.:
020977  Prod. No.: 001 RX (EQ 300MG BASE)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-65: Method of treatment of a patient infected with HIV
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleAUG 02,2007D-40: Once-a-day dosing regimen

ABACAVIR SULFATE (SOLUTION) ZIAGEN
Drug Classes: ANTIVIRALS
NDA Applicant: GLAXOSMITHKLINE      NDA No.:
020978  Prod. No.: 001 RX (EQ 20MG BASE/ML)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-65: Method of treatment of a patient infected with HIV
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleAUG 02,2007D-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)
PatentsExpirationPatented 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 *PEDU-257: Treatment of HIV infection
Pat. No. 5089500 Therapeutic nucleosides
Claim Types: Method of use
DEC 26,2009 *PEDU-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 *PEDU-257: Treatment of HIV infection
Pat. No. 6417191 DP* Synergistic combinations of zidovudine, 1592U89 and 3TC
Claim Types: Method of use; Composition; Formulation
MAR 28,2016U-257: Treatment of HIV infection
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleAUG 02,2007D-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)
PatentsExpirationPatented 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 *PEDU-248: Treatment of HIV
Pat. No. 5089500 Therapeutic nucleosides
Claim Types: Method of use
DEC 26,2009 *PEDU-248: Treatment of HIV
Pat. No. 5905082 DS* DP* Crystalline oxathiolane derivatives
Claim Types: Composition; Method of use
NOV 18,2016 *PEDU-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 *PEDU-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 28,2016U-248: Treatment of HIV

ABARELIX (INJECTABLE) PLENAXIS
NDA Applicant: PRAECIS      NDA No.:
021320  Prod. No.: 001 RX (100MG/VIAL)
PatentsExpirationPatented 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 11,2016U-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 07,2015U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityNOV 25,2008 

ACAMPROSATE CALCIUM (TABLET, DELAYED RELEASE) CAMPRAL
NDA Applicant: FOREST LABS      NDA No.:
021431  Prod. No.: 001 RX (333MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJUL 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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 14,2017U-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)
PatentsExpirationPatented Use
Pat. No. RE39221 DS* DP* Composition comprising a tramadol material and acetaminophen and its use
Claim Types: Formulation; Method of use
AUG 09,2011U-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)
PatentsExpirationPatented Use
Pat. No. 6261546 Methods and compositions for stabilizing acetylcholine compositions
Claim Types: Device; Method of use; Process
APR 29,2019U-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))
ExclusivityExpirationExclusivity Description
Exclusivity Code ODE: Orphan DrugJAN 23,2011For 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)
PatentsExpirationPatented Use
Pat. No. 4650807 [Extended 1469 days (4 years)]
Antihistaminic compositions and methods containing pyridine derivatives
Claim Types: Composition; Method of use
MAR 26,2008U-93: Use as an antihistamine/decongestant

ACYCLOVIR (CREAM) ZOVIRAX
Drug Classes: ANTIVIRALS
NDA Applicant: GLAXOSMITHKLINE      NDA No.:
021478  Prod. No.: 001 RX (5%)
PatentsExpirationPatented 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%)
PatentsExpirationPatented 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 31,2010U-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%)
PatentsExpirationPatented 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 31,2010U-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%)
PatentsExpirationPatented 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 31,2010U-275: Method of use of the drug substance

ADEFOVIR DIPIVOXIL (TABLET) HEPSERA
NDA Applicant: GILEAD      NDA No.:
021449  Prod. No.: 001 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 4724233 Therapeutical application of phosphonylmethoxyalkyl adenines
Claim Types: Method of use
APR 21,2006U-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 02,2014U-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 23,2018U-470: Therapy in chronic hepatitis B virus infection
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entitySEP 20,2007 

ADENOSINE (INJECTABLE) ADENOSCAN [Has competitive generic]
Drug Classes: ANTIARRHYTHMICS
NDA Applicant: ASTELLAS      NDA No.:
020059  Prod. No.: 001 RX (3MG/ML)
PatentsExpirationPatented Use
Pat. No. 5070877 [Extended 159 days* (0.4 years)]
Novel method of myocardial imaging
Claim Types: Diagnostic or surgical method
MAY 18,2009U-116: Method of myocardial imaging
Pat. No. 5731296 Selective vasodilation by continuous adenosine infusion
Claim Types: Method of use
MAR 24,2015U-221: Selective vasodilation by continuous adenosine infusion

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)
PatentsExpirationPatented 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 17,2009U-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 15,2015U-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)
PatentsExpirationPatented Use
Pat. No. 5529766 Contrast agents
Claim Types: Diagnostic or surgical method; Formulation; Process
JUN 25,2013U-505: Ultrasound contrast agent
Pat. No. 5558094 Methods for using persistent gases as ultrasound contrast media
Claim Types: Diagnostic or surgical method
FEB 28,2012U-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)
PatentsExpirationPatented 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 06,2010U-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)
PatentsExpirationPatented Use
Pat. No. 6702997 Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma
Claim Types: Method of use
DEC 28,2021U-558: Indicated for the relief of bronchospasm in patients 2-12 years of age with asthma (reversible obstructive airway disease)

ALBUTEROL SULFATE (AEROSOL, METERED) VENTOLIN HFA
NDA Applicant: GLAXOSMITHKLINE      NDA No.:
020983  Prod. No.: 001 RX (EQ 0.09MG BASE/INH)
PatentsExpirationPatented Use
Pat. No. 6131566 DP* Metered dose inhaler for albuterol
Claim Types: Device; Method of administration
APR 14,2015U-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 14,2015U-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 14,2015U-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 14,2015U-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)
PatentsExpirationPatented 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 06,2010U-491: Method of delivering a drug to the lung
Pat. No. 5766573 Medicinal aerosol formulations
Claim Types: Method of administration
NOV 28,2009U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationFEB 03,2009I-235: Prevention of exercise-induced bronchospasm in patients 12 years of age and older
Exclusivity Code: NP - New productOCT 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)
PatentsExpirationPatented 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%)
PatentsExpirationPatented 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 28,2021U-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%)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousDEC 21,2008M-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)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousDEC 21,2008M-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)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousDEC 21,2008M-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)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousDEC 21,2008M-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)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleAPR 16,2007D-87: Addition of once-weekly dosing for the treatment to increase bone mass in men with osteoporosis
Exclusivity Code: M - MiscellaneousDEC 21,2008M-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)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleAPR 16,2007D-87: Addition of once-weekly dosing for the treatment to increase bone mass in men with osteoporosis
Exclusivity Code: M - MiscellaneousDEC 21,2008M-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)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NC - New combinationAPR 07,2008 

ALFUZOSIN HYDROCHLORIDE (TABLET, EXTENDED RELEASE) UROXATRAL
NDA Applicant: SANOFI AVENTIS US      NDA No.:
021287  Prod. No.: 001 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 4661491 [Extension length not available]
Alfuzosine compositions and use
Claim Types: Method of use
MAY 27,2007U-706: Treatment of benign prostatic hyperplasia
Pat. No. 6149940 Tablet with controlled release of alfuzosine chlorhydrate
Claim Types: Formulation
AUG 22,2017 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJUN 12,2008 

ALITRETINOIN (GEL) PANRETIN
Drug Classes: DERMATOLOGICS
NDA Applicant: LIGAND      NDA No.:
020886  Prod. No.: 001 RX (EQ 0.1% BASE)
PatentsExpirationPatented 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 03,2016U-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code ODE: Orphan DrugFEB 02,2006Topical 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)
PatentsExpirationPatented Use
Pat. No. 5565447 [Extended 569 days (1.6 years)]
Indole derivatives
Claim Types: Compound; Method of use
Comments: This patent was extended under Sec. 156; expiration date includes the extension
MAY 07,2015 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMAY 07,2006 

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)
PatentsExpirationPatented Use
Pat. No. 5360800 DS* DP* Tetrahydro-1H-pyrido[4,3-b]indol-1-one derivatives
Claim Types: Compound; Composition; Method of use
JAN 13,2013U-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)
PatentsExpirationPatented 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)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NDF - New dosage formJAN 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented Use
Pat. No. 4801587 Impotence ointment
Claim Types: Method of use
JAN 31,2007U-155: Treatment of erectile dysfunction
Pat. No. 5242391 Urethral insert for treatment of erectile dysfunction
Claim Types: Device
SEP 07,2010U-155: Treatment of erectile dysfunction
Pat. No. 5474535 Dosage and inserter for treatment of erectile dysfunction
Claim Types: Device
DEC 12,2012U-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)
PatentsExpirationPatented 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 08,2017U-305: Methods for using the drug product
ExclusivityExpirationExclusivity Description
Exclusivity Code ODE: Orphan DrugJUN 24,2006Reduction 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%)
PatentsExpirationPatented 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 28,2009U-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 18,2010U-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 28,2009U-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 31,2017U-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 28,2009U-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%)
PatentsExpirationPatented Use
Pat. No. 5362737 Methods of treating aphthous ulcers and other mucocutaneous disorders with amlexanox
Claim Types: Method of use
NOV 08,2011U-243: Topical administration

AMLEXANOX (PATCH) AMLEXANOX
NDA Applicant: ULURU      NDA No.:
021727  Prod. No.: 001 RX (2MG)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NDF - New dosage formSEP 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)
PatentsExpirationPatented 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 *PEDU-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationSEP 28,2008I-472: Use in patients with angiographically documented coronary artery disease
Exclusivity Code: NPP - New patient populationJul 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)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-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 *PEDU-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 11,2018U-552: Treatment of hypertension and hyperlipidemia with a single composition
ExclusivityExpirationExclusivity Description
Exclusivity Code: NC - New combinationJAN 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)
PatentsExpirationPatented 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 19,2017U-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)
PatentsExpirationPatented 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 19,2017U-185: Method of treating hypertension
ExclusivityExpirationExclusivity Description
Exclusivity Code: NS - New strengthAPR 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)
PatentsExpirationPatented 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)
PatentsExpirationPatented Use
Pat. No. 6322819 Oral pulsed dose drug delivery system
Claim Types: Formulation
APR 21,2019 *PED 
Pat. No. 6605300 Oral pulsed dose drug delivery system
Claim Types: Formulation
APR 21,2019 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationAUG 11,2007 
Exclusivity Code: NPP - New patient populationJan 21,2009 PED 

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

AMPRENAVIR (SOLUTION) AGENERASE
Drug Classes: ANTIVIRALS
NDA Applicant: GLAXOSMITHKLINE      NDA No.:
021039  Prod. No.: 001 RX (15MG/ML)
PatentsExpirationPatented Use
Pat. No. 5585397 Sulfonamide inhibitors of aspartyl protease
Claim Types: Compound; Composition
DEC 17,2013 
Pat. No. 5646180 Treatment of the CNS effects of HIV
Claim Types: Method of use
JUL 08,2014U-257: Treatment of HIV infection
Pat. No. 5723490 THF-containing sulfonamide inhibitors of aspartyl protease
Claim Types: Composition; Method of use
MAR 03,2015U-257: Treatment of HIV infection

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

ANASTROZOLE (TABLET) ARIMIDEX
Drug Classes: ANTINEOPLASTICS
NDA Applicant: ASTRAZENECA      NDA No.:
020541  Prod. No.: 001 RX (1MG)
PatentsExpirationPatented Use
Pat. No. RE36617 (Substituted aralkyl) heterocyclic compounds
Claim Types: Compound; Composition; Method of use
DEC 27,2009 

ANIDULAFUNGIN (INJECTABLE) ERAXIS
NDA Applicant: VICURON      NDA No.:
021632  Prod. No.: 001 RX (50MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 5965525 DS* DP* Cyclic peptide antifungal agents
Claim Types: Compound; Method of use; Composition
OCT 12,2016U-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 19,2012U-540: Treatment of fungal infections
Pat. No. 6960564 DP* Echinocandin pharmaceutical formulations containing micelle-forming surfactants
Claim Types: Formulation; Process; Method of use
APR 12,2021U-540: Treatment of fungal infections
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityFEB 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))
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityAPR 20,2009 
Exclusivity Code ODE: Orphan DrugAPR 20,2011Treatment of the on-off fluctuations associated with late-stage Parkinson's disease.

APRACLONIDINE HYDROCHLORIDE (SOLUTION/DROPS) IOPIDINE
Drug Classes: OPHTHALMICS, MISCELLANEOUS
NDA Applicant: ALCON      NDA No.:
019779  Prod. No.: 001 RX (EQ 1% BASE)
PatentsExpirationPatented Use
Pat. No. 5212196 Control of post-surgical intraocular pressure using clonidine derivatives
Claim Types: Method of use
MAY 18,2010U-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)
PatentsExpirationPatented 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 23,2013U-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 29,2012U-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 01,2018U-745: Treatment or prevention of emesis
Pat. No. 6235735 Morpholine and thiomorpholine tachykinin receptor antagonists
Claim Types: Method of use
JUN 29,2012U-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 29,2012U-747: Prevention or treatment of post-operative nausea and vomiting
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationOCT 28,2008I-475: Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy
Exclusivity Code: NCE - New chemical entityMAR 26,2008 

APREPITANT (CAPSULE) EMEND
Drug Classes: ANTIEMETICS
NDA Applicant: MERCK      NDA No.:
021549  Prod. No.: 003 RX (40MG)
PatentsExpirationPatented 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 23,2013U-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 29,2012U-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 01,2018U-745: Treatment or prevention of emesis
Pat. No. 6235735 Morpholine and thiomorpholine tachykinin receptor antagonists
Claim Types: Method of use
JUN 29,2012U-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 29,2012U-747: Prevention or treatment of post-operative nausea and vomiting
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJUN 30,2009I-498: Prevention of postoperative nausea and vomiting
Exclusivity Code: NCE - New chemical entityMAR 26,2008 
Exclusivity Code: NS - New strengthJUN 30,2009 

ARBUTAMINE HYDROCHLORIDE (INJECTABLE) GENESA
NDA Applicant: GENSIA AUTOMEDICS      NDA No.:
020420  Prod. No.: 001 DISC (0.05MG/ML)
PatentsExpirationPatented 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 28,2009U-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 10,2010U-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)
PatentsExpirationPatented Use
Pat. No. 5214052 [Extended 1497 days (4.1 years)]
Method for dissolving arginineamides and pharmaceutical compositions containing them
Claim Types: Formulation; Process
JUN 30,2014 

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

ARIPIPRAZOLE (SOLUTION) ABILIFY
NDA Applicant: OTSUKA      NDA No.:
021713  Prod. No.: 001 RX (1MG/ML)
PatentsExpirationPatented Use
Pat. No. 5006528 DS* DP* [Extended 5 years]
Carbostyril derivatives
Claim Types: Compound; Composition
OCT 20,2014 
Pat. No. 6977257 DS* DP* Aripiprazole oral solution
Claim Types: Formulation
APR 24,2022 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationAUG 28,2006I-401: Longer-term efficacy of aripiprazole in the treatment of schizophrenia
Exclusivity Code: I - New IndicationSEP 29,2007I-437: Treatment of acute manic and mixed episodes associated with bipolar disorder
Exclusivity Code: I - New IndicationMAR 01,2008I-488: Maintenance therapy in bipolar I disorder
Exclusivity Code: NCE - New chemical entityNOV 15,2007 

ARSENIC TRIOXIDE (INJECTABLE) TRISENOX
NDA Applicant: CEPHALON      NDA No.:
021248  Prod. No.: 001 RX (1MG/ML)
PatentsExpirationPatented 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 10,2018U-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 10,2018U-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 10,2018U-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 10,2018U-651: Treatment of acute promyelocytic leukemia (APL)
ExclusivityExpirationExclusivity Description
Exclusivity Code ODE: Orphan DrugSEP 25,2007Treatment 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))
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMAR 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)
ExclusivityExpirationExclusivity Description
Exclusivity Code ODE: Orphan DrugSEP 09,2011Prevention 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)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productAUG 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)
PatentsExpirationPatented Use
Pat. No. 6015577 Pharmaceutical compositions containing dipyridamole or mopidamol and acetylsalicylic acid or the physiologically acceptable salts thereof, processes for preparing them and their use in treating clot formation
Claim Types: Formulation; Method of use
JAN 18,2017U-302: To reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis

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)
PatentsExpirationPatented 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 *PEDU-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)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleJUL 06,2007D-89: Use of REYATAZ 300 mg/ritonavir 100 mg once daily for treatment in HIV-infected antiretroviral-experienced patients
Exclusivity Code: NCE - New chemical entityJUN 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)
PatentsExpirationPatented Use
Pat. No. 5658590 Treatment of attention-deficit/hyperactivity disorder
Claim Types: Method of use
MAY 26,2017 *PEDU-494: Treatment of Attention-Deficit Hyperactivity Disorder
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMay 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)
PatentsExpirationPatented 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 *PEDU-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 *PEDU-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 *PEDU-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 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationApr 18,2006 PEDI-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 IndicationJUL 30,2007I-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 IndicationSEP 21,2008I-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 - MiscellaneousJUL 30,2007M-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)
PatentsExpirationPatented Use
Pat. No. 4981874 Medicaments
Claim Types: Method of use
FEB 15,2010 *PEDU-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)
PatentsExpirationPatented Use
Pat. No. 4981874 Medicaments
Claim Types: Method of use
FEB 15,2010 *PEDU-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 *PEDU-69: Treatment of pneumocystis carinii infections
ExclusivityExpirationExclusivity Description
Exclusivity Code ODE: Orphan DrugJul 05,2006 PED 

ATOVAQUONE; PROGUANIL HYDROCHLORIDE (TABLET) MALARONE
Drug Classes: ANTIMALARIALS
NDA Applicant: GLAXOSMITHKLINE      NDA No.:
021078  Prod. No.: 001 RX (250MG;100MG)
PatentsExpirationPatented 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 *PEDU-406: Method of use of atovaquone and proguanil
Pat. No. 6291488 Preventing protozoal infections
Claim Types: Method of use
MAY 25,2014 *PEDU-406: Method of use of atovaquone and proguanil

ATOVAQUONE; PROGUANIL HYDROCHLORIDE (TABLET) MALARONE PEDIATRIC
Drug Classes: ANTIMALARIALS
NDA Applicant: GLAXOSMITHKLINE      NDA No.:
021078  Prod. No.: 002 RX (62.5MG;25MG)
PatentsExpirationPatented 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 
Pat. No. 6291488 Preventing protozoal infections
Claim Types: Method of use
MAY 25,2014 *PEDU-406: Method of use of atovaquone and proguanil
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJun 02,2007 PED 

ATROPINE SULFATE; EDROPHONIUM CHLORIDE (INJECTABLE) ENLON-PLUS
Drug Classes: ANTIDOTES, SPECIFIC
NDA Applicant: BAXTER HLTHCARE CORP      NDA No.:
019677  Prod. No.: 001 RX (0.14MG/ML;10MG/ML)
PatentsExpirationPatented Use
Pat. No. 4952586 Edrophonium-atropine composition and therapeutic uses thereof
Claim Types: Composition; Method of use
AUG 28,2007U-54: Reversal agent or antagonist of nondepolarizing neuromuscular blocking agents

ATROPINE SULFATE; EDROPHONIUM CHLORIDE (INJECTABLE) ENLON-PLUS
Drug Classes: ANTIDOTES, SPECIFIC
NDA Applicant: BAXTER HLTHCARE CORP      NDA No.:
019678  Prod. No.: 001 RX (0.14MG/ML;10MG/ML)
PatentsExpirationPatented Use
Pat. No. 4952586 Edrophonium-atropine composition and therapeutic uses thereof
Claim Types: Composition; Method of use
AUG 28,2007U-54: Reversal agent or antagonist of nondepolarizing neuromuscular blocking agents

AVOBENZONE; ECAMSULE; OCTOCRYLENE (CREAM) ANTHELIOS SX
NDA Applicant: LOREAL USA      NDA No.:
021502  Prod. No.: 001 OTC (2%;2%;10%)
PatentsExpirationPatented Use
Pat. No. 4585597 DS* DP* [Extension length not available]
3-benzylidene-camphors, process for their preparation and their use in protection against UV rays
Claim Types: Compound; Process; Composition; Formulation; Method of use
JUN 16,2007U-752: Sunscreen
Pat. No. 5587150 DP* Photostable cosmetic screening composition containing a UV-A screening agent and an alkyl .beta., .beta.-diphenylacrylate or .alpha.-cyano-.beta. , .beta.-diphenylacrylate
Claim Types: Formulation; Method of use
DEC 24,2013U-752: Sunscreen
ExclusivityExpirationExclusivity Description
Exclusivity Code: NC - New combinationJUL 21,2009 

AZACITIDINE (INJECTABLE) VIDAZA
NDA Applicant: PHARMION      NDA No.:
050794  Prod. No.: 001 RX (100MG/VIAL)
ExclusivityExpirationExclusivity Description
Exclusivity Code ODE: Orphan DrugMAY 19,2011Treatment of myelodysplasic syndromes.

AZELAIC ACID (GEL) FINACEA
Drug Classes: ACNE PRODUCTS
NDA Applicant: INTENDIS      NDA No.:
021470  Prod. No.: 001 RX (15%)
PatentsExpirationPatented Use
Pat. No. 4713394 Treatment of nonacne inflammatory and infectious dermatoses and hair loss
Claim Types: Method of use
JAN 17,2006U-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 

AZELASTINE HYDROCHLORIDE (SPRAY, METERED) ASTELIN
Drug Classes: ANTIHISTAMINES
NDA Applicant: MEDPOINTE PHARM HLC      NDA No.:
020114  Prod. No.: 001 RX (EQ 0.125MG BASE/SPRAY)
PatentsExpirationPatented Use
Pat. No. 5164194 [Extended 349 days* (1 years)]
Azelastine containing medicaments
Claim Types: Method of use
MAY 01,2011 *PEDU-207: Use as nasal spray
ExclusivityExpirationExclusivity Description
Exclusivity Code: D - New Dosing ScheduleFEB 17,2009D-102: New dosing regimen of one spray twice daily for seasonal alleric rhinitis in patients 12 yrs of age and older

AZELASTINE HYDROCHLORIDE (SOLUTION/DROPS) OPTIVAR
NDA Applicant: MEDPOINTE PHARM HLC      NDA No.:
021127  Prod. No.: 001 RX (0.05%)
PatentsExpirationPatented Use
Pat. No. 5164194 [Extended 349 days* (1 years)]
Azelastine containing medicaments
Claim Types: Method of use
MAY 01,2011 *PED 


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