PEPCID Drug Patent Profile

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Pepcid is a drug marketed by Salix Pharms, Merck, Bausch, J And J Consumer Inc, and Merck Sharp Dohme. and is included in nine NDAs.

The generic ingredient in PEPCID is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and eighty-two drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

US Patents:	0
Applicants:	5
NDAs:	9
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	35
Patent Applications:	6,700
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PEPCID
What excipients (inactive ingredients) are in PEPCID?	PEPCID excipients list
DailyMed Link:	PEPCID at DailyMed

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

Sponsor	Phase
Ohio State University Comprehensive Cancer Center	Phase 2/Phase 3
Leidos Life Sciences	Phase 2
United States Department of Defense	Phase 2

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

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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
Salix Pharms	PEPCID	famotidine	FOR SUSPENSION;ORAL	019527-001	Feb 2, 1987		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020325-001	Apr 28, 1995		OTC	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch	PEPCID	famotidine	TABLET;ORAL	019462-002	Oct 15, 1986		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Merck Sharp Dohme	PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER	famotidine	INJECTABLE;INJECTION	020249-001	Feb 18, 1994		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020902-001	Aug 5, 1999		OTC	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Merck	PEPCID RPD	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	020752-002	May 28, 1998		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Merck	PEPCID	famotidine	INJECTABLE;INJECTION	019510-001	Nov 4, 1986		DISCN	Yes	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	PEPCID	famotidine	TABLET;ORAL	019462-001	Oct 15, 1986	⤷ Try a Trial	⤷ Try a Trial
Bausch	PEPCID	famotidine	TABLET;ORAL	019462-002	Oct 15, 1986	⤷ Try a Trial	⤷ Try a Trial
Salix Pharms	PEPCID	famotidine	FOR SUSPENSION;ORAL	019527-001	Feb 2, 1987	⤷ Try a Trial	⤷ Try a Trial
Merck	PEPCID	famotidine	INJECTABLE;INJECTION	019510-001	Nov 4, 1986	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

See the table below for patents covering PEPCID around the world.

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Country	Patent Number	Title	Estimated Expiration
Germany	2951675		⤷ Try a Trial
Philippines	16099	GUANIDINOTHIAZOLE COMPOUNDS,PROCESS FOR PREPARING THEM AND MEDICAL COMPOSITION CONTAINING THEM	⤷ Try a Trial
Japan	S55118476	NOVEL AMIDINE DERIVATIVE AND ITS PREPARATION	⤷ Try a Trial
Sweden	7910568		⤷ Try a Trial
Philippines	15657	GUANIDINOTHIAZOLE COMPOUNDS,PROCESS FOR PREPARATION AND GASTRIC INHIBITING COMPOSITIONS CONTAINING THEM	⤷ Try a Trial
U.S.S.R.	876056	METHOD OF PRODUCING GUANIDINOTHIAZOLE COMPOUNDS	⤷ Try a Trial
United Kingdom	2055800	GUANIDINOTHIAZOLES AND THEIR PREPARATION AND USE	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration