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Last Updated: July 4, 2020

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ASACOL Drug 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 is included in two NDAs. There are three patents protecting this drug and two Paragraph IV challenges.

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

US ANDA Litigation and Generic Entry Outlook for Asacol

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

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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

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SponsorPhase
Queen Elizabeth Hospital, Hong KongN/A
Tseung Kwan O Hospital, Hong KongN/A
Alice Ho Miu Ling Nethersole HospitalN/A

See all ASACOL clinical trials

Paragraph IV (Patent) Challenges for ASACOL
Tradename Dosage Ingredient NDA Submissiondate
ASACOL TABLET, DELAYED RELEASE;ORAL mesalamine 019651 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   Start Trial   Start Trial   Start Trial
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 AB RX 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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
Johnson and Johnson
Baxter
Dow
Colorcon

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