ACAMPROSATE CALCIUM - Generic Drug Details
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What are the generic sources for acamprosate calcium and what is the scope of freedom to operate?
Acamprosate calcium
is the generic ingredient in two branded drugs marketed by Barr Labs Div Teva, Glenmark Pharms Ltd, Mylan, Zydus Pharms, and Forest Labs, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.There are six drug master file entries for acamprosate calcium. Six suppliers are listed for this compound.
Summary for ACAMPROSATE CALCIUM
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 5 |
NDAs: | 5 |
Drug Master File Entries: | 6 |
Finished Product Suppliers / Packagers: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 81 |
Clinical Trials: | 7 |
Patent Applications: | 983 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in ACAMPROSATE CALCIUM? | ACAMPROSATE CALCIUM excipients list |
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 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Forest Labs | CAMPRAL | acamprosate calcium | TABLET, DELAYED RELEASE;ORAL | 021431-001 | Jul 29, 2004 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
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 | ||||
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 |