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.
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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 |
|---|---|---|---|
| United Kingdom | 8322387 | ⤷ Sign Up | |
| Italy | 1149328 | COMPOSIZIONE FARMACEUTICA PER LA SOMMINISTRAZIONE PER VIA ORALE DI COMPOSTI CHE DEBBONO ESSERE ASSORBITI NELL'INTESTINO CRASSO | ⤷ Sign Up |
| Canada | 1172570 | COMPOSES PHARMACEUTIQUES ADMINISTRES PAR VOIE ORALE (ORALLY ADMINISTRABLE PHARMACEUTICAL COMPOSITIONS) | ⤷ Sign Up |
| Finland | 85216 | ⤷ Sign Up | |
| United Kingdom | 2123695 | ORALLY ADMINISTRABLE PHARMACEUTICAL COMPOSITIONS | ⤷ Sign Up |
| Denmark | 128283 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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.
ISSN: 2162-2639
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