Asacol Drug Patent 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 Abbvie and is included in two NDAs.
The generic ingredient in ASACOL 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
A generic version of Asacol was approved as mesalamine by PADAGIS ISRAEL on September 17th, 2004.
Summary for Asacol
US Patents: | 0 |
Applicants: | 2 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 181 |
Clinical Trials: | 35 |
Patent Applications: | 3,771 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for Asacol |
What excipients (inactive ingredients) are in Asacol? | Asacol excipients list |
DailyMed Link: | Asacol at DailyMed |
Recent Clinical Trials for Asacol
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Shiraz University of Medical Sciences | Phase 1/Phase 2 |
ZonMw: The Netherlands Organisation for Health Research and Development | Phase 3 |
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Phase 3 |
Paragraph IV (Patent) Challenges for ASACOL
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ASACOL | Delayed-release Tablets | mesalamine | 400 mg | 019651 | 1 | 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Apil | ASACOL | mesalamine | TABLET, DELAYED RELEASE;ORAL | 019651-001 | Jan 31, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
Apil | ASACOL | mesalamine | TABLET, DELAYED RELEASE;ORAL | 019651-001 | Jan 31, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for Asacol
See the table below for patents covering Asacol around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Africa | 8205384 | ⤷ Try a Trial | |
Japan | H0414083 | ⤷ Try a Trial | |
Denmark | 128283 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |