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Last Updated: April 22, 2024

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 Ajanta Pharma Ltd, Akorn, Alkem Labs Ltd, Amneals Pharms, Annora Pharma, Carnegie, Cerovene Inc, Lupin Ltd, Micro Labs, Navinta Llc, Novel Labs Inc, Novitium Pharma, Upsher Smith Labs, Salix Pharms, Apotex Inc, Apothecon, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Sagent, Zydus Pharms, Epic Pharma Llc, Abbvie, Baxter Hlthcare, Merck, Merck Sharp Dohme, Perrigo, J And J Consumer Inc, Ucb Inc, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Ascent Pharms Inc, Aurobindo Pharma, Aurobindo Pharma Ltd, Carlsbad, Chartwell Rx, Contract Pharmacal, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Graviti Pharms, Ivax Sub Teva Pharms, Mankind Pharma, Marksans Pharma, Mylan, Mylan Pharms Inc, P And L, Perrigo R And D, Rising, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Vkt Pharma, Watson Labs, Bausch, Horizon, and Teva Pharms Usa, and is included in ninety-two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for famotidine. One hundred and thirty-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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Mainline Biosciences, Inc.Early Phase 1
Assistance Publique - Hôpitaux de ParisPhase 2/Phase 3
INSERM U 1163 - Laboratory of molecular mechanisms of hematologic disorders and therapeutic implications, ParisPhase 2/Phase 3

See all famotidine clinical trials

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

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
Chartwell Rx FAMOTIDINE famotidine TABLET;ORAL 075786-001 Apr 16, 2001 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
J And J Consumer Inc PEPCID AC famotidine TABLET;ORAL 020325-002 Sep 23, 2003 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Perrigo R And D FAMOTIDINE famotidine TABLET;ORAL 077352-002 Jul 27, 2005 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
J And J Consumer Inc PEPCID AC famotidine TABLET, CHEWABLE;ORAL 020801-001 Sep 24, 1998 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apothecon FAMOTIDINE PRESERVATIVE FREE famotidine INJECTABLE;INJECTION 075708-001 Apr 16, 2001 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a Trial ⤷  Try a Trial
J And J Consumer Inc PEPCID AC famotidine TABLET;ORAL 020325-001 Apr 28, 1995 ⤷  Try a Trial ⤷  Try a Trial
J And J Consumer Inc PEPCID AC famotidine TABLET, CHEWABLE;ORAL 020801-002 Dec 17, 2007 ⤷  Try a Trial ⤷  Try a Trial
J And J Consumer Inc PEPCID AC famotidine TABLET, CHEWABLE;ORAL 020801-001 Sep 24, 1998 ⤷  Try a Trial ⤷  Try a Trial
Merck PEPCID PRESERVATIVE FREE famotidine INJECTABLE;INJECTION 019510-004 Nov 4, 1986 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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