FDA Orange Book · active-ingredient family
Acamprosate calcium
Acamprosate calcium is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CAMPRAL · NDA 021431
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, delayed release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CAMPRALRLD | FOREST LABS | NDA 021431 | — | Jul 29, 2004 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ACAMPROSATE CALCIUM | APPCO | ANDA 218984 | AB | Mar 16, 2026 | |
| ACAMPROSATE CALCIUM | BIONPHARMA | ANDA 219904 | AB | Sep 18, 2025 | |
| ACAMPROSATE CALCIUM | ZYDUS PHARMS | ANDA 205995 | AB | May 26, 2017 | |
| ACAMPROSATE CALCIUM | MYLAN | ANDA 200142 | AB | Mar 11, 2014 | |
| ACAMPROSATE CALCIUM | BARR LABS DIV TEVA | ANDA 200143 | — | Nov 18, 2013 | |
| ACAMPROSATE CALCIUM | GLENMARK PHARMS LTD | ANDA 202229 | AB | Jul 16, 2013 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Acamprosate calcium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
