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Last Updated: August 14, 2020

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PEPCID AC Drug Profile

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When do Pepcid Ac patents expire, and what generic alternatives are available?

Pepcid Ac is a drug marketed by J And J Consumer Inc and is included in three NDAs. There is one patent protecting this drug.

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

US ANDA Litigation and Generic Entry Outlook for Pepcid Ac

A generic version of PEPCID AC was approved as famotidine by ATHENEX INC on April 16th, 2001.

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Drug patent expirations by year for PEPCID AC
Recent Clinical Trials for PEPCID AC

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SponsorPhase
Northwell HealthPhase 3
M.D. Anderson Cancer CenterPhase 1
University of ChicagoPhase 2

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Paragraph IV (Patent) Challenges for PEPCID AC
Tradename Dosage Ingredient NDA Submissiondate
PEPCID AC TABLET, CHEWABLE;ORAL famotidine 020801

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

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

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