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Last Updated: August 14, 2020

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PEPCID Drug Profile

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

Pepcid is a drug marketed by Salix Pharms, Merck, Valeant Pharms North, J And J Consumer Inc, and Merck Sharp Dohme. and is included in nine NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

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-five suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

US ANDA Litigation and Generic Entry Outlook for Pepcid

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Drug patent expirations by year for PEPCID
Drug Prices for PEPCID

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Recent Clinical Trials for PEPCID

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

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

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Pharmacology for PEPCID
Paragraph IV (Patent) Challenges for PEPCID
Tradename Dosage Ingredient NDA Submissiondate
PEPCID TABLET;ORAL famotidine 019462

US Patents and Regulatory Information for PEPCID

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   Start Trial   Start Trial   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
Valeant Pharms North PEPCID famotidine TABLET;ORAL 019462-002 Oct 15, 1986 DISCN Yes No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER famotidine INJECTABLE;INJECTION 020249-001 Feb 18, 1994 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
Merck PEPCID RPD famotidine TABLET, ORALLY DISINTEGRATING;ORAL 020752-002 May 28, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Merck PEPCID famotidine INJECTABLE;INJECTION 019510-001 Nov 4, 1986 DISCN 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

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

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Serving leading biopharmaceutical companies globally:

Moodys
McKesson
Merck
Boehringer Ingelheim
AstraZeneca
Baxter

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