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

Summary for famotidine

US Patents:	7
Tradenames:	11
Applicants:	40
NDAs:	68
Drug Master File Entries:	18
Suppliers / Packagers:	90
Bulk Api Vendors:	70
Clinical Trials:	84
Patent Applications:	7,284
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for famotidine
Drug Sales Revenues:	Drug sales revenues for famotidine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for famotidine
DailyMed Link:	famotidine at DailyMed

See drug prices for famotidine

See drug sales revenues for famotidine

Recent Clinical Trials for famotidine

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

Sponsor	Phase
drpykessupplements.com	Phase 4
Profact, Inc.	Phase 2
Reema Padia	Phase 1/Phase 2

See all famotidine clinical trials

Generic filers with tentative approvals for FAMOTIDINE

Applicant	Application No.	Strength	Dosage Form
		10MG/ML	Injectable; Injection
		10MG/ML	Injectable; Injection
		10MG/ML	Injectable; 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

Drug Class	Histamine-2 Receptor Antagonist
Mechanism of Action	Histamine H2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for famotidine

Anti-Ulcer Agents

Histamine H2 Antagonists

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
Sun Pharm Inds Ltd	FAMOTIDINE	famotidine	TABLET;ORAL	090283-001	Nov 17, 2009		OTC	No	No
Sandoz	FAMOTIDINE	famotidine	TABLET;ORAL	075793-001	Apr 16, 2001		DISCN	No	No
Salix Pharms	PEPCID	famotidine	FOR SUSPENSION;ORAL	019527-001	Feb 2, 1987		DISCN	Yes	No
Aurobindo Pharma Ltd	FAMOTIDINE	famotidine	TABLET;ORAL	206531-002	Apr 26, 2016		OTC	No	No
Wockhardt	FAMOTIDINE	famotidine	TABLET;ORAL	077146-001	Mar 7, 2005		OTC	No	No
Watson Labs	FAMOTIDINE	famotidine	TABLET;ORAL	075062-002	Apr 16, 2001		DISCN	No	No

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
Ucb Inc	FLUXID	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	021712-002	Sep 24, 2004
Merck	PEPCID RPD	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	020752-001	May 28, 1998
Ucb Inc	FLUXID	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	021712-001	Sep 24, 2004
Salix Pharms	PEPCID	famotidine	FOR SUSPENSION;ORAL	019527-001	Feb 2, 1987
Valeant Pharms North	PEPCID	famotidine	TABLET;ORAL	019462-002	Oct 15, 1986
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020902-001	Aug 5, 1999