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.

Summary for FAMOTIDINE

US Patents:	5
Tradenames:	14
Applicants:	62
NDAs:	97
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	144
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	118
Patent Applications:	7,350
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

Drug Sales Revenue Trends for FAMOTIDINE

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Recent Clinical Trials for FAMOTIDINE

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

Sponsor	Phase
University of Miami	Phase 3
Celgene	Phase 1
Emory University	Phase 3

See all FAMOTIDINE clinical trials

Generic filers with tentative approvals for FAMOTIDINE

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

US Patents and Regulatory Information for FAMOTIDINE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Pharms Inc	FAMOTIDINE	famotidine	TABLET;ORAL	077146-001	Mar 7, 2005		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ivax Sub Teva Pharms	FAMOTIDINE	famotidine	TABLET;ORAL	075511-001	Apr 16, 2001	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Contract Pharmacal	FAMOTIDINE	famotidine	TABLET;ORAL	217669-001	Dec 20, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	FAMOTIDINE	famotidine	TABLET;ORAL	218181-001	Dec 22, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novitium Pharma	FAMOTIDINE	famotidine	FOR SUSPENSION;ORAL	215043-001	Apr 20, 2021	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vkt Pharma	FAMOTIDINE	famotidine	TABLET;ORAL	215822-001	Jan 28, 2022		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ucb Inc	FLUXID	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	021712-002	Sep 24, 2004		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

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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	⤷ Sign Up	⤷ Sign Up
Ucb Inc	FLUXID	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	021712-002	Sep 24, 2004	⤷ Sign Up	⤷ Sign Up
Ucb Inc	FLUXID	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	021712-001	Sep 24, 2004	⤷ Sign Up	⤷ Sign Up
Salix Pharms	PEPCID	famotidine	FOR SUSPENSION;ORAL	019527-001	Feb 2, 1987	⤷ Sign Up	⤷ Sign Up
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020325-001	Apr 28, 1995	⤷ Sign Up	⤷ Sign Up
Merck	PEPCID RPD	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	020752-002	May 28, 1998	⤷ Sign Up	⤷ Sign Up
Merck Sharp Dohme	PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER	famotidine	INJECTABLE;INJECTION	020249-001	Feb 18, 1994	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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