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Last Updated: April 25, 2024

ASACOL HD Drug Patent Profile


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Which patents cover Asacol Hd, and what generic alternatives are available?

Asacol Hd is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in ASACOL HD 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 Hd

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

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Drug patent expirations by year for ASACOL HD
Drug Prices for ASACOL HD

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Drug Sales Revenue Trends for ASACOL HD

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Recent Clinical Trials for ASACOL HD

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 HD clinical trials

Paragraph IV (Patent) Challenges for ASACOL HD
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ASACOL HD Delayed-release Tablets mesalamine 800 mg 021830 1 2011-07-13

US Patents and Regulatory Information for ASACOL HD

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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

Expired US Patents for ASACOL HD

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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