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Famotidine - Generic Drug Details

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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, Eurohlth Intl Sarl, Baxter Hlthcare, Hi-tech Pharma Co, Novel Labs Inc, and Horizon Pharma, and is included in sixty-nine NDAs. There are eleven 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:11
Applicants:36
NDAs:69
Drug Master File Entries: see list18
Suppliers / Packaging: see list120
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: famotidine

Tentative approvals for FAMOTIDINE

Applicant Application No. Form Dosage
<disabled><disabled>Injectable; Injection10MG/ML
<disabled><disabled>Injectable; Injection10MG/ML
<disabled><disabled>Injectable; Injection10MG/ML
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa
FAMOTIDINE
famotidine
INJECTABLE;INJECTION075709-001Apr 16, 2001RXNo► subscribe► subscribe
Eurohlth Intl Sarl
FAMOTIDINE PRESERVATIVE FREE
famotidine
INJECTABLE;INJECTION075486-001Apr 16, 2001RXYes► subscribe► subscribe
Teva
FAMOTIDINE
famotidine
TABLET;ORAL075312-001May 31, 2001OTCNo► 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, 19984,305,502► subscribe
Valeant Pharms North
PEPCID
famotidine
TABLET;ORAL019462-002Oct 15, 19864,283,408*PED► subscribe
J And J Consumer Inc
PEPCID AC
famotidine
TABLET, CHEWABLE;ORAL020801-001Sep 24, 19985,075,114*PED► subscribe
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International Patent Family for Ingredient: famotidine

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9846215► subscribe
Portugal2147669► subscribe
European Patent Office2147669► 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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