Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 11, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020801

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NDA 020801 describes PEPCID AC, which is a drug marketed by J And J Consumer Inc and is included in three NDAs. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the PEPCID AC profile page.

The generic ingredient in PEPCID AC is famotidine. There are eighteen drug master file entries for this compound. One hundred and six suppliers are listed for this compound. Additional details are available on the famotidine profile page.
Summary for 020801
Tradename:PEPCID AC
Applicant:J And J Consumer Inc
Ingredient:famotidine
Patents:1
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020801
Paragraph IV (Patent) Challenges for 020801
Tradename Dosage Ingredient NDA Submissiondate
PEPCID AC TABLET, CHEWABLE;ORAL famotidine 020801

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, CHEWABLE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Sep 24, 1998TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:OTCDosage:TABLET, CHEWABLE;ORALStrength20MG
Approval Date:Dec 17, 2007TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Feb 26, 2022Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 020801

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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, CHEWABLE;ORAL 020801-001 Sep 24, 1998   Start Trial   Start Trial
J And J Consumer Inc PEPCID AC famotidine TABLET, CHEWABLE;ORAL 020801-002 Dec 17, 2007   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, CHEWABLE;ORAL 020801-001 Sep 24, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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