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Serving 500+ biopharmaceutical companies globally:

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Argus Health
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QuintilesIMS
Accenture
Covington
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Fish and Richardson
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Generated: September 25, 2017

DrugPatentWatch Database Preview

Famotidine - Generic Drug Details

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What are the generic drug sources for famotidine and what is the scope of famotidine patent protection?

Famotidine
is the generic ingredient in eleven branded drugs marketed by Perrigo, J And J Consumer Inc, Sandoz, Mylan, Watson Labs, Hospira, Carlsbad, Apothecon, Fresenius Kabi Usa, Merck, Apotex, Ivax Sub Teva Pharms, Teva, Ucb Inc, Alembic Pharms Ltd, Dr Reddys Labs Ltd, Navinta Llc, Athenex Inc, Apotex Inc, Salix Pharms, Abbvie, Aurobindo Pharma Ltd, Wockhardt, Sun Pharm Inds, Lupin Ltd, Mylan Labs Ltd, Merck Sharp Dohme, Actavis Elizabeth, Perrigo R And D, Mylan Pharms Inc, Valeant Pharms North, Sun Pharm Inds Ltd, West-ward Pharms Int, Baxter Hlthcare, Hi-tech Pharma Co, Novel Labs Inc, and Horizon Pharma, and is included in sixty-nine NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Famotidine has thirteen patent family members in nine countries.

There are eighteen drug master file entries for famotidine. One hundred and twenty-four suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for Generic Name: famotidine

Tradenames:11
Patents:9
Applicants:37
NDAs:69
Drug Master File Entries: see list18
Suppliers / Packagers: see list124
Bulk Api Vendors: see list47
Clinical Trials: see list56
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:famotidine at DailyMed

Pharmacology for Ingredient: famotidine

Tentative approvals for FAMOTIDINE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe10MG/MLInjectable; Injection
► Subscribe► Subscribe10MG/MLInjectable; Injection
► Subscribe► Subscribe10MG/MLInjectable; Injection
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER
famotidine
INJECTABLE;INJECTION020249-001Feb 18, 1994DISCNYesNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Ltd
FAMOTIDINE
famotidine
TABLET;ORAL077367-001Sep 25, 2006OTCNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
FAMOTIDINE
famotidine
TABLET;ORAL075457-002Apr 18, 2001DISCNNoNo► Subscribe► Subscribe► Subscribe
Apotex
FAMOTIDINE
famotidine
TABLET;ORAL075611-002Jul 23, 2001ABRXNoNo► Subscribe► Subscribe► Subscribe
Ivax Sub Teva Pharms
FAMOTIDINE
famotidine
TABLET;ORAL075511-001Apr 16, 2001ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin Ltd
FAMOTIDINE
famotidine
FOR SUSPENSION;ORAL090440-001Jun 29, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Horizon Pharma
DUEXIS
famotidine; ibuprofen
TABLET;ORAL022519-001Apr 23, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Sun Pharm Inds
FAMOTIDINE
famotidine
TABLET;ORAL075639-002Dec 12, 2001DISCNNoNo► Subscribe► Subscribe► Subscribe
Hospira
FAMOTIDINE PRESERVATIVE FREE
famotidine
INJECTABLE;INJECTION075669-001Apr 16, 2001DISCNNoNo► Subscribe► Subscribe► Subscribe
Mylan
FAMOTIDINE
famotidine
TABLET;ORAL075704-002Apr 16, 2001ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: famotidine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
PEPCID RPD
famotidine
TABLET, ORALLY DISINTEGRATING;ORAL020752-002May 28, 1998► Subscribe► Subscribe
J And J Consumer Inc
PEPCID AC
famotidine
TABLET;ORAL020325-001Apr 28, 1995► Subscribe► Subscribe
J And J Consumer Inc
PEPCID AC
famotidine
TABLET, CHEWABLE;ORAL020801-001Sep 24, 1998► Subscribe► Subscribe
Valeant Pharms North
PEPCID
famotidine
TABLET;ORAL019462-002Oct 15, 1986► Subscribe► Subscribe
J And J Consumer Inc
PEPCID AC
famotidine
TABLET;ORAL020902-001Aug 5, 1999► Subscribe► Subscribe
J And J Consumer Inc
PEPCID AC
famotidine
TABLET;ORAL020902-001Aug 5, 1999► Subscribe► Subscribe
J And J Consumer Inc
PEPCID AC
famotidine
TABLET;ORAL020902-001Aug 5, 1999► Subscribe► Subscribe
J And J Consumer Inc
PEPCID AC
famotidine
TABLET, CHEWABLE;ORAL020801-001Sep 24, 1998► Subscribe► Subscribe
Merck
PEPCID RPD
famotidine
TABLET, ORALLY DISINTEGRATING;ORAL020752-001May 28, 1998► Subscribe► Subscribe
J And J Consumer Inc
PEPCID AC
famotidine
TABLET, CHEWABLE;ORAL020801-001Sep 24, 1998► Subscribe► Subscribe
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International Patent Family for Ingredient: famotidine

Country Document Number Estimated Expiration
Hong Kong1137654► Subscribe
Denmark2147669► Subscribe
Japan2012162558► Subscribe
Canada2284663► Subscribe
Australia726336► Subscribe
Australia6896998► Subscribe
World Intellectual Property Organization (WIPO)9846215► Subscribe
Japan5072513► Subscribe
European Patent Office0975336► Subscribe
European Patent Office2266538► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving 500+ biopharmaceutical companies globally:

Teva
Medtronic
Boehringer Ingelheim
Deloitte
Harvard Business School
Cipla
Chubb
Express Scripts
Fuji
Farmers Insurance

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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