pepcid ac Drug Patent Profile

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-nine 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.

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

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

See all pepcid ac clinical trials

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

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
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020902-001	Aug 5, 1999		OTC	No	No
J And J Consumer Inc	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-002	Dec 17, 2007		OTC	Yes	Yes
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020325-001	Apr 28, 1995		OTC	Yes	No
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020325-002	Sep 23, 2003		OTC	Yes	Yes

Expired US Patents for pepcid ac

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020902-001	Aug 5, 1999
J And J Consumer Inc	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-001	Sep 24, 1998
J And J Consumer Inc	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-002	Dec 17, 2007
J And J Consumer Inc	PEPCID AC	famotidine	TABLET, CHEWABLE;ORAL	020801-001	Sep 24, 1998
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020902-001	Aug 5, 1999
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020325-001	Apr 28, 1995
J And J Consumer Inc	PEPCID AC	famotidine	TABLET;ORAL	020902-001	Aug 5, 1999

International Patents for pepcid ac

See the table below for patents covering pepcid ac around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0319318	METHOD FOR DOUBLE DIPPING GELATIN COATED CAPLETS
Philippines	26940	Apparatus for gelatin coating caplets
Netherlands	7909321
Greece	1002292	ΜΕΘΟΔΟΙ ΠΑΡΑΣΚΕΥΗΣ ΒΕΛΤΙΩΜΕΝΩΝ ΚΕΚΑΛΥΜΕΝΩΝ ΦΑΡΜΑΚΩΝ ΚΑΙ ΣΥΣΚΕΥΗ ΓΙΑ ΤΗΝ ΠΑΡΑΣΚΕΥΗ ΤΟΥΣ. (METHODS FOR THE PREPARATION OF IMPROVED COATED MEDICAMENTS AND APPARATUS FOR MAKING SAME)
Canada	1134836	METHODE DE PREPARATION DE NOUVEAUX GUANIDINOTHIAZOLES (PROCESS FOR PREPARING NOVEL GUANIDINOTHIAZOLE COMPOUNDS)
Latvia	5493	Guanidinotiazolu savienojumu iegusanas panemiens
Japan	S565469	NOVEL AMIDINE DERIVATIVE AND ITS PREPARATION