FDA Orange Book · active-ingredient family
Amisulpride
Amisulpride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:BARHEMSYS · NDA 209510
1
Brand (NDA)
0
Generics (ANDA)
8
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BARHEMSYSRLD×2 | ACACIA | NDA 209510 | — | Feb 26, 2020 |
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9545426 | Mar 10, 2031 | in 4 yr 10 mo | U-1744 |
| 9889118 | Mar 10, 2031 | in 4 yr 10 mo | U-2754 |
| 12194022 | Mar 10, 2031 | in 4 yr 10 mo | U-1744 |
| 10525033 | Mar 10, 2031 | in 4 yr 10 mo | Product |
| 9084765 | Feb 26, 2034 | in 7 yr 10 mo | U-1744 |
| 12005042 | Feb 09, 2038 | in 11 yr 10 mo | U-1744 |
| 11357753 | Feb 09, 2038 | in 11 yr 10 mo | U-2754 |
| 12329740 | Feb 09, 2038 | in 11 yr 10 mo | U-2754 |
Amisulpride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
