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Last Updated: August 8, 2020

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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 eleven branded drugs marketed by Hi-tech Pharma Co, Lupin Ltd, Navinta Llc, Novel Labs Inc, Salix Pharms, Apotex Inc, Apothecon, Athenex Inc, Fresenius Kabi Usa, Hospira, Mylan Labs Ltd, West-ward Pharms Int, Abbvie, Baxter Hlthcare, Merck, Merck Sharp Dohme, Perrigo, J And J Consumer Inc, Ucb Inc, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Aurobindo Pharma Ltd, Carlsbad, Celltrion, Dr Reddys Labs Ltd, Ivax Sub Teva Pharms, Mylan, Mylan Pharms Inc, P And L, Perrigo R And D, Pld Acquisitions, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Watson Labs, Wockhardt, Valeant Pharms North, and Horizon, and is included in sixty-eight 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. Eighty-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
Janssen Research & Development, LLCPhase 1
Idorsia Pharmaceuticals Ltd.Phase 1
Northwell HealthPhase 3

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Generic filers with tentative approvals for FAMOTIDINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial10MG/MLInjectable; Injection
  Start Trial  Start Trial10MG/MLInjectable; Injection
  Start Trial  Start 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 famotidine INJECTABLE;INJECTION 075870-001 Nov 23, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc FAMOTIDINE famotidine TABLET;ORAL 075457-001 Apr 18, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
West-ward Pharms Int FAMOTIDINE famotidine INJECTABLE;INJECTION 075488-001 Apr 16, 2001 AP RX No Yes   Start Trial   Start Trial   Start Trial
Teva FAMOTIDINE famotidine TABLET;ORAL 075312-001 May 31, 2001 DISCN No No   Start Trial   Start Trial   Start 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
Merck PEPCID RPD famotidine TABLET, ORALLY DISINTEGRATING;ORAL 020752-001 May 28, 1998   Start Trial   Start Trial
Ucb Inc FLUXID famotidine TABLET, ORALLY DISINTEGRATING;ORAL 021712-002 Sep 24, 2004   Start Trial   Start Trial
J And J Consumer Inc PEPCID AC famotidine TABLET, CHEWABLE;ORAL 020801-001 Sep 24, 1998   Start Trial   Start Trial
J And J Consumer Inc PEPCID AC famotidine TABLET;ORAL 020325-001 Apr 28, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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