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Last Updated: January 24, 2022

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Famotidine - Generic Drug Details

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What are the generic drug sources for famotidine and what is the scope of freedom to operate?

Famotidine is the generic ingredient in twelve branded drugs marketed by Akorn, Lupin Ltd, Navinta Llc, Novel Labs Inc, Novitium Pharma, Salix Pharms, Apotex Inc, Apothecon, Athenex Inc, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Abbvie, Baxter Hlthcare, Merck, Merck Sharp Dohme, Perrigo, J And J Consumer Inc, Ucb Inc, Actavis Elizabeth, Alembic Pharms Ltd, Annora Pharma, Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Carlsbad, Celltrion, Dr Reddys Labs Ltd, Ivax Sub Teva Pharms, Mankind Pharma, Mylan, Mylan Pharms Inc, P And L, Perrigo R And D, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Watson Labs, Wockhardt, Bausch, Horizon, Alkem Labs Ltd, and Teva Pharms Usa, and is included in seventy-five NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for famotidine. Ninety-seven suppliers are listed for this compound. There are five tentative approvals for this compound.

Drug Prices for famotidine

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Drug Sales Revenue Trends for famotidine

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Recent Clinical Trials for famotidine

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SponsorPhase
INSERM U 1163 - Laboratory of molecular mechanisms of hematologic disorders and therapeutic implications, ParisPhase 2/Phase 3
Assistance Publique - Hôpitaux de ParisPhase 2/Phase 3
Ultragenyx Pharmaceutical IncPhase 1/Phase 2

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Generic filers with tentative approvals for FAMOTIDINE
Applicant Application No. Strength Dosage Form
⤷  Sign up for a Free Trial⤷  Sign up for a Free Trial10MG/MLInjectable; Injection
⤷  Sign up for a Free Trial⤷  Sign up for a Free Trial10MG/MLInjectable; Injection
⤷  Sign up for a Free Trial⤷  Sign up for a Free Trial10MG/MLInjectable; Injection

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for famotidine
Medical Subject Heading (MeSH) Categories for famotidine
Paragraph IV (Patent) Challenges for FAMOTIDINE
Tradename Dosage Ingredient NDA Submissiondate
PEPCID TABLET;ORAL famotidine 019462
PEPCID AC TABLET, CHEWABLE;ORAL famotidine 020801

US Patents and Regulatory Information for famotidine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira FAMOTIDINE PRESERVATIVE FREE famotidine INJECTABLE;INJECTION 075669-001 Apr 16, 2001 DISCN No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Perrigo R And D FAMOTIDINE famotidine TABLET;ORAL 077352-001 Jul 27, 2005 AB RX No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Wockhardt FAMOTIDINE famotidine TABLET;ORAL 090837-001 Aug 4, 2010 OTC No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Merck PEPCID RPD famotidine TABLET, ORALLY DISINTEGRATING;ORAL 020752-002 May 28, 1998 DISCN No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Athenex Inc FAMOTIDINE PRESERVATIVE FREE famotidine INJECTABLE;INJECTION 075825-001 Apr 17, 2001 AP RX No No ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for famotidine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc PEPCID AC famotidine TABLET;ORAL 020325-001 Apr 28, 1995 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Ucb Inc FLUXID famotidine TABLET, ORALLY DISINTEGRATING;ORAL 021712-002 Sep 24, 2004 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Merck PEPCID RPD famotidine TABLET, ORALLY DISINTEGRATING;ORAL 020752-001 May 28, 1998 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Ucb Inc FLUXID famotidine TABLET, ORALLY DISINTEGRATING;ORAL 021712-001 Sep 24, 2004 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
Salix Pharms PEPCID famotidine FOR SUSPENSION;ORAL 019527-001 Feb 2, 1987 ⤷  Sign up for a Free Trial ⤷  Sign up for a Free Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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