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Last Updated: March 28, 2024

Asacol Drug Patent Profile


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

Asacol is a drug marketed by Apil and Abbvie and is included in two NDAs.

The generic ingredient in ASACOL is mesalamine. There are twenty-eight drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Asacol

A generic version of Asacol was approved as mesalamine by PADAGIS ISRAEL on September 17th, 2004.

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Summary for Asacol
Drug patent expirations by year for Asacol
Drug Prices for Asacol

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Drug Sales Revenue Trends for Asacol

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Recent Clinical Trials for Asacol

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

SponsorPhase
Shiraz University of Medical SciencesPhase 1/Phase 2
ZonMw: The Netherlands Organisation for Health Research and DevelopmentPhase 3
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Phase 3

See all Asacol clinical trials

Paragraph IV (Patent) Challenges for ASACOL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ASACOL Delayed-release Tablets mesalamine 400 mg 019651 1 2007-06-22

US Patents and Regulatory Information for Asacol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil ASACOL mesalamine TABLET, DELAYED RELEASE;ORAL 019651-001 Jan 31, 1992 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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