ACAMPROSATE CALCIUM Drug Patent Profile
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When do Acamprosate Calcium patents expire, and what generic alternatives are available?
Acamprosate Calcium is a drug marketed by Barr Labs Div Teva, Glenmark Pharms Ltd, Mylan, and Zydus Pharms. and is included in four NDAs.
The generic ingredient in ACAMPROSATE CALCIUM is acamprosate calcium. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acamprosate calcium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Acamprosate Calcium
A generic version of ACAMPROSATE CALCIUM was approved as acamprosate calcium by MYLAN on March 11th, 2014.
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Summary for ACAMPROSATE CALCIUM
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 81 |
| Clinical Trials: | 7 |
| Patent Applications: | 598 |
| DailyMed Link: | ACAMPROSATE CALCIUM at DailyMed |
Recent Clinical Trials for ACAMPROSATE CALCIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Technische Universität Dresden | Phase 3 |
| Dayanand Medical College and Hospital | Phase 4 |
| Synchroneuron Inc. | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for ACAMPROSATE CALCIUM
US Patents and Regulatory Information for ACAMPROSATE CALCIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Barr Labs Div Teva | ACAMPROSATE CALCIUM | acamprosate calcium | TABLET, DELAYED RELEASE;ORAL | 200143-001 | Nov 18, 2013 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zydus Pharms | ACAMPROSATE CALCIUM | acamprosate calcium | TABLET, DELAYED RELEASE;ORAL | 205995-001 | May 26, 2017 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Glenmark Pharms Ltd | ACAMPROSATE CALCIUM | acamprosate calcium | TABLET, DELAYED RELEASE;ORAL | 202229-001 | Jul 16, 2013 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan | ACAMPROSATE CALCIUM | acamprosate calcium | TABLET, DELAYED RELEASE;ORAL | 200142-001 | Mar 11, 2014 | AB | RX | No | 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 |
