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Last Updated: April 12, 2021

DrugPatentWatch Database Preview

PEPCID COMPLETE Drug Profile

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When do Pepcid Complete patents expire, and when can generic versions of Pepcid Complete launch?

Pepcid Complete is a drug marketed by J And J Consumer Inc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

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

DrugPatentWatch® Generic Entry Outlook for Pepcid Complete

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 COMPLETE
Recent Clinical Trials for PEPCID COMPLETE

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SponsorPhase
Emory UniversityPhase 4
Profact, Inc.Phase 2
Reema PadiaPhase 1/Phase 2

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Paragraph IV (Patent) Challenges for PEPCID COMPLETE
Tradename Dosage Ingredient NDA Submissiondate
PEPCID COMPLETE TABLET, CHEWABLE;ORAL calcium carbonate; famotidine; magnesium hydroxide 020958 2004-11-01

US Patents and Regulatory Information for PEPCID COMPLETE

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 COMPLETE calcium carbonate; famotidine; magnesium hydroxide TABLET, CHEWABLE;ORAL 020958-001 Oct 16, 2000 OTC Yes Yes   Start Trial   Start Trial Y   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 COMPLETE

Supplementary Protection Certificates for PEPCID COMPLETE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0521471 C300125 Netherlands   Start Trial PRODUCT NAME: ROSUVASTATINUM, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET CALCIUMZOUT; REGISTRATION NO/DATE: RVG 26872 - RVG 26874 20021106
2957286 2018/046 Ireland   Start Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170719
2957286 300962 Netherlands   Start Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: EU/1/17/1179 20170721
0933372 13/2008 Austria   Start Trial PRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713
0720599 300689 Netherlands   Start Trial PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN ATORVASTATINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ATORVASTATINE CALCIUM TRIHYDRATE; NATIONAL REGISTRATION NO/DATE: RVG114373-114376 20141027; FIRST REGISTRATION: FR 2014091200122 20140912
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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