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Last Updated: November 7, 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 fourteen branded drugs marketed by Ajanta Pharma Ltd, Akorn, Alkem Labs Ltd, Amneals Pharms, Annora Pharma, Carnegie, Lupin Ltd, Micro Labs, Navinta Llc, Novel Labs Inc, Novitium Pharma, Unichem, 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, MSN, Mylan Pharms Inc, Natco Pharma, P And L, Perrigo R And D, Rising, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Vkt Pharma, Watson Labs, Bausch, Horizon, Torrent, Endo Operations, and Teva Pharms Usa, and is included in ninety-seven 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 forty-four 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
University of MiamiPhase 3
CelgenePhase 1
CURE Drug Repurposing Collaboratory (CDRC)Phase 3

See all FAMOTIDINE clinical trials

Generic filers with tentative approvals for FAMOTIDINE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up10MG/MLInjectable; Injection
⤷  Sign Up⤷  Sign Up10MG/MLInjectable; Injection
⤷  Sign Up⤷  Sign Up10MG/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
Alkem Labs Ltd FAMOTIDINE famotidine TABLET;ORAL 217375-001 Apr 24, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msn FAMOTIDINE famotidine TABLET;ORAL 217400-001 Aug 6, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apothecon FAMOTIDINE PRESERVATIVE FREE famotidine INJECTABLE;INJECTION 075708-001 Apr 16, 2001 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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, CHEWABLE;ORAL 020801-002 Dec 17, 2007 ⤷  Sign Up ⤷  Sign Up
J And J Consumer Inc PEPCID AC famotidine TABLET;ORAL 020902-001 Aug 5, 1999 ⤷  Sign Up ⤷  Sign Up
Bausch PEPCID famotidine TABLET;ORAL 019462-001 Oct 15, 1986 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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