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Last Updated: July 12, 2020

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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.

US ANDA Litigation and 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
Northwell HealthPhase 3
M.D. Anderson Cancer CenterPhase 1
University of ChicagoPhase 2

See all PEPCID COMPLETE clinical trials

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
0720599 CR 2014 00050 Denmark   Start Trial PRODUCT NAME: EZETIMIBE AND ATORVASTATIN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING ATORVASTATIN AS ATORVASTATIN CALCIUM TRIHYDRATE; REG. NO/DATE: DE/H/3895-3898/001-004/DC 20140910
0933372 SPC/GB08/018 United Kingdom   Start Trial PRODUCT NAME: FOSAMPRENAVIR CALCIUM: ((1S,2R)-3-(((4-AMINOPHENYL)SULFONYL)(2-METHYLPROPYL)AMINO)-1-(PHENYLMETHYL)-2(PHOSPHONOOXY)PROPYL)-CARBABAMIC ACID C-((3S)-TETRAHYDRO-3-FURANYL) ESTER CALCIUM SALT; REGISTERED: UK EU/1/04/282/001 20040712; UK EU/1/04/282/002 20040712
2957286 C02957286/01 Switzerland   Start Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66411 22.12.2017
2957286 LUC00094 Luxembourg   Start Trial PRODUCT NAME: PATIROMER SORBITEX CALCIUM; AUTHORISATION NUMBER AND DATE: EU/1/17/1179 20170721
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Medtronic
Harvard Business School
McKesson
Mallinckrodt
Baxter

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