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Famotidine - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for famotidine?

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, Amphastar Pharms Inc, Apotex Inc, Salix Pharms, Abbvie, Aurobindo Pharma Ltd, Wockhardt, Sun Pharm Inds, Lupin Ltd, Mylan Labs Ltd, Merck Sharp Dohme, Actavis Elizabeth, Mylan Pharms Inc, Valeant Pharms North, Sun Pharm Inds Ltd, West-ward Pharms Int, Eurohlth Intl Sarl, 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.

This ingredient has thirteen patent family members in nine countries.

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

Summary for Generic Name: famotidine

Tradenames:11
Patents:10
Applicants:37
NDAs:69
Drug Master File Entries: see list18
Suppliers / Packagers: see list120
Bulk Api Vendors: see list47
Clinical Trials: see list23
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. Form Dosage
► Subscribe► SubscribeInjectable; Injection10MG/ML
► Subscribe► SubscribeInjectable; Injection10MG/ML
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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Perrigo
FAMOTIDINE
famotidine
TABLET;ORAL077352-001Jul 27, 2005RXNoNo► Subscribe► Subscribe
Ucb Inc
FLUXID
famotidine
TABLET, ORALLY DISINTEGRATING;ORAL021712-001Sep 24, 2004DISCNNoNo6,221,392► SubscribeY ► Subscribe
Alembic Pharms Ltd
FAMOTIDINE
famotidine
TABLET;ORAL078916-001May 22, 2009RXNoNo► Subscribe► Subscribe
Merck
PEPCID
famotidine
INJECTABLE;INJECTION019510-001Nov 4, 1986DISCNYesNo► Subscribe► Subscribe
Apothecon
FAMOTIDINE
famotidine
INJECTABLE;INJECTION075707-001Apr 16, 2001DISCNNoNo► 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
J And J Consumer Inc
PEPCID AC
famotidine
TABLET;ORAL020902-001Aug 5, 19995,854,267*PED► Subscribe
Valeant Pharms North
PEPCID
famotidine
TABLET;ORAL019462-001Oct 15, 19864,283,408*PED► Subscribe
Merck Sharp Dohme
PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER
famotidine
INJECTABLE;INJECTION020249-001Feb 18, 19944,283,408*PED► Subscribe
Salix Pharms
PEPCID
famotidine
FOR SUSPENSION;ORAL019527-001Feb 2, 19874,283,408*PED► Subscribe
Merck
PEPCID RPD
famotidine
TABLET, ORALLY DISINTEGRATING;ORAL020752-002May 28, 19984,371,516► Subscribe
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International Patent Family for Ingredient: famotidine

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9846215► Subscribe
Japan2001524956► Subscribe
Australia6896998► Subscribe
European Patent Office2266538► Subscribe
Denmark2147669► 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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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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