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.