ASACOL HD Drug Patent Profile
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Which patents cover Asacol Hd, and what generic alternatives are available?
Asacol Hd is a drug marketed by Abbvie and is included in one NDA.
The generic ingredient in ASACOL HD 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 Hd
A generic version of ASACOL HD was approved as mesalamine by PADAGIS ISRAEL on September 17th, 2004.
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Summary for ASACOL HD
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 181 |
| Clinical Trials: | 35 |
| Patent Applications: | 4,186 |
| Drug Prices: | Drug price information for ASACOL HD |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ASACOL HD |
| What excipients (inactive ingredients) are in ASACOL HD? | ASACOL HD excipients list |
| DailyMed Link: | ASACOL HD at DailyMed |
Recent Clinical Trials for ASACOL HD
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 HD
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ASACOL HD | Delayed-release Tablets | mesalamine | 800 mg | 021830 | 1 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 HD
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie | ASACOL HD | mesalamine | TABLET, DELAYED RELEASE;ORAL | 021830-001 | May 29, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | ASACOL HD | mesalamine | TABLET, DELAYED RELEASE;ORAL | 021830-001 | May 29, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | ASACOL HD | mesalamine | TABLET, DELAYED RELEASE;ORAL | 021830-001 | May 29, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | ASACOL HD | mesalamine | TABLET, DELAYED RELEASE;ORAL | 021830-001 | May 29, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | ASACOL HD | mesalamine | TABLET, DELAYED RELEASE;ORAL | 021830-001 | May 29, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ASACOL HD
See the table below for patents covering ASACOL HD around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Peru | 20020529 | FORMA DE DOSIFICACION FARMACEUTICA CON MULTIPLES RECUBRIMIENTOS PARA REDUCIR EL IMPACTO DE FRACTURAS DEL RECUBRIMIENTO | ⤷ Sign Up |
| Hungary | 0402230 | ⤷ Sign Up | |
| New Zealand | 532564 | Solid unit dosage forms for oral administration which minimise the impact of coating fractures especially for larger or heavier dosage forms | ⤷ Sign Up |
| Japan | 2005510539 | ⤷ Sign Up | |
| United Kingdom | 8322387 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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