➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
Dow
Mallinckrodt
Johnson and Johnson
McKinsey

Last Updated: July 12, 2020

DrugPatentWatch Database Preview

ASACOL HD Drug Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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. 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-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 Hd

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

  Start Trial

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

See drug prices for ASACOL HD

Drug Sales Revenue Trends for ASACOL HD

See drug sales revenues for ASACOL HD

Recent Clinical Trials for ASACOL HD

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

SponsorPhase
Tseung Kwan O Hospital, Hong KongN/A
Alice Ho Miu Ling Nethersole HospitalN/A
Chinese University of 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   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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
Dow
Mallinckrodt
Johnson and Johnson
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.