PEPCID AC Drug Patent Profile

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Which patents cover Pepcid Ac, and what generic alternatives are available?

Pepcid Ac is a drug marketed by J And J Consumer Inc and is included in three NDAs.

The generic ingredient in PEPCID AC is famotidine. There are eighteen drug master file entries for this compound. One hundred and thirty-seven suppliers are listed for this compound. Additional details are available on the famotidine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Pepcid Ac

A generic version of PEPCID AC was approved as famotidine by FRESENIUS KABI USA on April 16^th, 2001.

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Summary for PEPCID AC

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	35
Patent Applications:	7,161
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in PEPCID AC?	PEPCID AC excipients list
DailyMed Link:	PEPCID AC at DailyMed

Drug patent expirations by year for PEPCID AC

Recent Clinical Trials for PEPCID AC

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

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Pharmacology for PEPCID AC

Drug Class	Histamine-2 Receptor Antagonist
Mechanism of Action	Histamine H2 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for PEPCID AC

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 PEPCID AC

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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
J And J Consumer Inc	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-001	Sep 24, 1998		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
J And J Consumer Inc	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-002	Dec 17, 2007		OTC	Yes	Yes	⤷ 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
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020325-002	Sep 23, 2003		OTC	Yes	Yes	⤷ 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 PEPCID AC

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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	020801-001	Sep 24, 1998	⤷ 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
J And J Consumer Inc	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-001	Sep 24, 1998	⤷ 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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for PEPCID AC

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

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Country	Patent Number	Title	Estimated Expiration
Netherlands	180420		⤷ Try a Trial
Portugal	97739	PROCESSO PARA A PREPARACAO DE UMA PASTILHA MEDICAMENTOSA MASCAVEL E PARA MASCARAR O SABOR DE MEDICAMENTOS	⤷ Try a Trial
Ireland	910598		⤷ Try a Trial
New Zealand	223449	GELATIN-COATED SOLID CAPLET MEDICAMENT AND PROCESS AND APPARATUS FOR MAKING SAME	⤷ Try a Trial
United Kingdom	2055800	GUANIDINOTHIAZOLES AND THEIR PREPARATION AND USE	⤷ Try a Trial
Philippines	26940	Apparatus for gelatin coating caplets	⤷ Try a Trial
Portugal	96837	DISPOSITIVO E PROCESSO PARA A PREPARACAO DE MEDICAMENTOS REVESTIDOS APERFEICOADOS	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Summary for PEPCID AC

Recent Clinical Trials for PEPCID AC

Pharmacology for PEPCID AC

Anatomical Therapeutic Chemical (ATC) Classes for PEPCID AC

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