➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Dow
Mallinckrodt
McKesson
Johnson and Johnson
Harvard Business School
Baxter

Last Updated: January 28, 2021

DrugPatentWatch Database Preview

Famotidine - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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. Ninety suppliers are listed for this compound. There are five tentative approvals for this compound.

Drug Prices for famotidine

See drug prices for famotidine

Drug Sales Revenue Trends for famotidine

See drug sales revenues for famotidine

Recent Clinical Trials for famotidine

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

SponsorPhase
drpykessupplements.comPhase 4
Profact, Inc.Phase 2
Reema PadiaPhase 1/Phase 2

See all famotidine clinical trials

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 AC TABLET, CHEWABLE;ORAL famotidine 020801
PEPCID TABLET;ORAL famotidine 019462

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
Athenex Inc FAMOTIDINE PRESERVATIVE FREE famotidine INJECTABLE;INJECTION 075622-001 Apr 16, 2001 AP RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Ltd FAMOTIDINE famotidine TABLET;ORAL 090283-001 Nov 17, 2009 OTC No No   Start Trial   Start Trial   Start Trial
Sandoz FAMOTIDINE famotidine TABLET;ORAL 075793-001 Apr 16, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Salix Pharms PEPCID famotidine FOR SUSPENSION;ORAL 019527-001 Feb 2, 1987 DISCN Yes No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd FAMOTIDINE famotidine TABLET;ORAL 206531-002 Apr 26, 2016 OTC No No   Start Trial   Start Trial   Start Trial
Wockhardt FAMOTIDINE famotidine TABLET;ORAL 077146-001 Mar 7, 2005 OTC No No   Start Trial   Start Trial   Start Trial
Watson Labs FAMOTIDINE famotidine TABLET;ORAL 075062-002 Apr 16, 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
J And J Consumer Inc PEPCID AC famotidine TABLET;ORAL 020325-001 Apr 28, 1995   Start Trial   Start Trial
Ucb Inc FLUXID famotidine TABLET, ORALLY DISINTEGRATING;ORAL 021712-002 Sep 24, 2004   Start Trial   Start Trial
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 021712-001 Sep 24, 2004   Start Trial   Start Trial
Salix Pharms PEPCID famotidine FOR SUSPENSION;ORAL 019527-001 Feb 2, 1987   Start Trial   Start Trial
Valeant Pharms North PEPCID famotidine TABLET;ORAL 019462-002 Oct 15, 1986   Start Trial   Start Trial
J And J Consumer Inc PEPCID AC famotidine TABLET;ORAL 020902-001 Aug 5, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
Colorcon
Medtronic
Merck
Baxter

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 verification 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.