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Last Updated: April 25, 2024

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 Ajanta Pharma Ltd, Akorn, Alkem Labs Ltd, Amneals Pharms, Annora Pharma, Carnegie, Cerovene Inc, Lupin Ltd, Micro Labs, Navinta Llc, Novel Labs Inc, Novitium Pharma, 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, Mylan, Mylan Pharms Inc, P And L, Perrigo R And D, Rising, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Vkt Pharma, Watson Labs, Bausch, Horizon, and Teva Pharms Usa, and is included in ninety-two 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 thirty-seven suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for famotidine

US Patents:	5
Tradenames:	12
Applicants:	59
NDAs:	92
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	137
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	112
Patent Applications:	7,875
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

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

Sponsor	Phase
Mainline Biosciences, Inc.	Early Phase 1
Assistance Publique - Hôpitaux de Paris	Phase 2/Phase 3
INSERM U 1163 - Laboratory of molecular mechanisms of hematologic disorders and therapeutic implications, Paris	Phase 2/Phase 3

See all famotidine clinical trials

Generic filers with tentative approvals for FAMOTIDINE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	10MG/ML	Injectable; Injection
⤷ Try a Trial	⤷ Try a Trial	10MG/ML	Injectable; Injection
⤷ Try a Trial	⤷ Try a Trial	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

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
Ucb Inc	FLUXID	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	021712-001	Sep 24, 2004		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hospira	FAMOTIDINE	famotidine	INJECTABLE;INJECTION	075905-001	Nov 23, 2001		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	FAMOTIDINE	famotidine	INJECTABLE;INJECTION	075488-001	Apr 16, 2001	AP	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mankind Pharma	FAMOTIDINE	famotidine	TABLET;ORAL	075302-001	Apr 16, 2001	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Upsher Smith Labs	FAMOTIDINE	famotidine	FOR SUSPENSION;ORAL	217655-001	Jun 16, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	FAMOTIDINE	famotidine	TABLET;ORAL	075607-002	May 10, 2001		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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

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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	⤷ Try a Trial	⤷ Try a Trial
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020325-001	Apr 28, 1995	⤷ Try a Trial	⤷ Try a Trial
J And J Consumer Inc	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-002	Dec 17, 2007	⤷ Try a Trial	⤷ Try a Trial
J And J Consumer Inc	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-001	Sep 24, 1998	⤷ Try a Trial	⤷ Try a Trial
Merck	PEPCID PRESERVATIVE FREE	famotidine	INJECTABLE;INJECTION	019510-004	Nov 4, 1986	⤷ Try a Trial	⤷ Try a Trial
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020325-001	Apr 28, 1995	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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