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. Forty 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for ASACOL?
- What are the global sales for ASACOL?
- What is Average Wholesale Price for ASACOL?
Summary for ASACOL
US Patents: | 0 |
Applicants: | 2 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 181 |
Clinical Trials: | 35 |
Patent Applications: | 4,183 |
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 |
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Phase 3 |
ZonMw: The Netherlands Organisation for Health Research and Development | 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Abbvie | ASACOL HD | mesalamine | TABLET, DELAYED RELEASE;ORAL | 021830-001 | May 29, 2008 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Apil | ASACOL | mesalamine | TABLET, DELAYED RELEASE;ORAL | 019651-001 | Jan 31, 1992 | ⤷ Sign Up | ⤷ Sign Up |
>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 | ⤷ Sign Up | |
Finland | 85216 | ⤷ Sign Up | |
Denmark | 158931 | ⤷ Sign Up | |
Australia | 551173 | ⤷ Sign Up | |
Denmark | 128283 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |