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Last Updated: September 25, 2022

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 Apil 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-one 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
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Phase 3
ZonMw: The Netherlands Organisation for Health Research and DevelopmentPhase 3

See all ASACOL HD clinical trials

Pharmacology for ASACOL HD
Drug ClassAminosalicylate
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
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 See Plans and Pricing See Plans and Pricing
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 See Plans and Pricing See Plans and Pricing
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 See Plans and Pricing See Plans and Pricing
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 See Plans and Pricing See Plans and Pricing
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ASACOL HD

See the table below for patents covering ASACOL HD around the world.

Country Patent Number Title Estimated Expiration
Germany 60133319 See Plans and Pricing
Portugal 1453487 See Plans and Pricing
Norway 830948 See Plans and Pricing
World Intellectual Property Organization (WIPO) 8300435 See Plans and Pricing
Brazil PI0117180 composição farmacêutica em uma forma de unidade sólida de dosagem para a administração oral a um ser humano ou animal inferior See Plans and Pricing
World Intellectual Property Organization (WIPO) 03045356 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
Dow
Mallinckrodt
Johnson and Johnson
McKinsey

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