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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 twelve branded drugs marketed by Akorn, Lupin Ltd, Navinta Llc, Novel Labs Inc, Novitium Pharma, Salix Pharms, Apotex Inc, Apothecon, Athenex Inc, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Abbvie, Baxter Hlthcare, Merck, Merck Sharp Dohme, Perrigo, J And J Consumer Inc, Ucb Inc, Actavis Elizabeth, Alembic Pharms Ltd, Annora Pharma, Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Carlsbad, Celltrion, Dr Reddys Labs Ltd, Ivax Sub Teva Pharms, Mankind Pharma, Mylan, Mylan Pharms Inc, P And L, Perrigo R And D, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Watson Labs, Wockhardt, Bausch, Horizon, Alkem Labs Ltd, and Teva Pharms Usa, and is included in seventy-five 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-seven suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for famotidine

US Patents:	7
Tradenames:	12
Applicants:	45
NDAs:	75
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	97
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	108
Patent Applications:	7,317
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
What excipients (inactive ingredients) are in famotidine?	famotidine excipients list
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
INSERM U 1163 - Laboratory of molecular mechanisms of hematologic disorders and therapeutic implications, Paris	Phase 2/Phase 3
Assistance Publique - Hôpitaux de Paris	Phase 2/Phase 3
Ultragenyx Pharmaceutical Inc	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

Anatomical Therapeutic Chemical (ATC) Classes for famotidine

A02BA	H2-receptor antagonists
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

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 PRESERVATIVE FREE	famotidine	INJECTABLE;INJECTION	075669-001	Apr 16, 2001		DISCN	No	No
Perrigo R And D	FAMOTIDINE	famotidine	TABLET;ORAL	077352-001	Jul 27, 2005	AB	RX	No	No
Wockhardt	FAMOTIDINE	famotidine	TABLET;ORAL	090837-001	Aug 4, 2010		OTC	No	No
Merck	PEPCID RPD	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	020752-002	May 28, 1998		DISCN	No	No
Athenex Inc	FAMOTIDINE PRESERVATIVE FREE	famotidine	INJECTABLE;INJECTION	075825-001	Apr 17, 2001	AP	RX	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