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, Amneals Pharms, Lupin Ltd, Navinta Llc, Novel Labs Inc, Novitium Pharma, Salix Pharms, Apotex Inc, Apothecon, Athenex Inc, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Zydus Pharms, Abbvie, Baxter Hlthcare, Merck, Merck Sharp Dohme, Perrigo, J And J Consumer Inc, Ucb Inc, Actavis Elizabeth, Alembic Pharms Ltd, Alkem Labs Ltd, Annora Pharma, Apotex, Ascent Pharms Inc, Aurobindo Pharma, Aurobindo Pharma Ltd, Carlsbad, Celltrion, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Ivax Sub Teva Pharms, Mankind 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 eighty NDAs. There are six 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 thirteen suppliers are listed for this compound.

Summary for famotidine

US Patents:	6
Tradenames:	12
Applicants:	50
NDAs:	80
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	113
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	111
Patent Applications:	7,290
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

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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
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

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
Dr Reddys Labs Ltd	FAMOTIDINE	famotidine	TABLET;ORAL	075718-002	Apr 16, 2001	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Abbvie	FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER	famotidine	INJECTABLE;INJECTION	075729-001	Dec 17, 2001		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Zydus Pharms	FAMOTIDINE	famotidine	TABLET;ORAL	216441-001	Jun 3, 2022	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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, CHEWABLE;ORAL	020801-001	Sep 24, 1998	See Plans and Pricing	See Plans and Pricing
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020325-001	Apr 28, 1995	See Plans and Pricing	See Plans and Pricing
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020902-001	Aug 5, 1999	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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.