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Last Updated: July 31, 2021

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ASACOL HD Drug Patent Profile


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

Asacol Hd is a drug marketed by Apil and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-one patent family members in seventeen countries.

The generic ingredient in ASACOL HD is mesalamine. There are twenty-eight drug master file entries for this compound. Twenty-eight 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 PERRIGO 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

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SponsorPhase
Chinese University of Hong KongN/A
Queen Elizabeth Hospital, Hong KongN/A
Tseung Kwan O Hospital, Hong KongN/A

See all ASACOL HD clinical trials

Pharmacology for ASACOL HD
Drug ClassAminosalicylate
Paragraph IV (Patent) Challenges for ASACOL HD
Tradename Dosage Ingredient NDA Submissiondate
ASACOL HD TABLET, DELAYED RELEASE;ORAL mesalamine 021830 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 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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:

Dow
Mallinckrodt
Harvard Business School
Moodys
AstraZeneca
Medtronic

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