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Last Updated: January 21, 2020

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CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE - Generic Drug Details

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What are the generic sources for calcium carbonate; famotidine; magnesium hydroxide and what is the scope of freedom to operate?

Calcium carbonate; famotidine; magnesium hydroxide is the generic ingredient in two branded drugs marketed by Perrigo R And D and J And J Consumer Inc, and is included in three NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are two hundred and eighty-two drug master file entries for calcium carbonate; famotidine; magnesium hydroxide. Twenty-five suppliers are listed for this compound.

Recent Litigation for CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Brigham and Women's Hospital, Inc. v. Perrigo Company2013-07-09
Santarus Inc. v. Par Pharmaceutical Inc.2007-09-13
Pfizer Inc. v. Ranbaxy Laboratories Limited2007-03-09

See all CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE litigation

PTAB Litigation
PetitionerDate
Perrigo Company2014-09-26

See all CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE litigation

Paragraph IV (Patent) Challenges for CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE
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 CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Perrigo R And D FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE calcium carbonate; famotidine; magnesium hydroxide TABLET, CHEWABLE;ORAL 077355-001 Feb 6, 2008 OTC No No   Start Trial   Start Trial   Start Trial
Perrigo R And D FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE calcium carbonate; famotidine; magnesium hydroxide TABLET, CHEWABLE;ORAL 204782-001 Aug 29, 2016 OTC No No   Start Trial   Start Trial   Start Trial
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 CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKesson
Baxter
Harvard Business School
Medtronic
AstraZeneca

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