FDA Orange Book · active-ingredient family
Safinamide mesylate
Safinamide mesylate is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:XADAGO · NDA 207145
1
Brand (NDA)
4
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| XADAGORLD×2 | MDD US | NDA 207145 | AB | Mar 21, 2017 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SAFINAMIDE MESYLATE×2 | ZENARA | ANDA 215913 | AB | Jun 13, 2025 | |
| SAFINAMIDE MESYLATE×2 | MSN | ANDA 215978 | AB | Dec 31, 2024 | |
| SAFINAMIDE MESYLATE×2 | PRINSTON INC | ANDA 215739 | AB | Apr 25, 2024 | |
| SAFINAMIDE MESYLATE×2 | AUROBINDO PHARMA | ANDA 215902 | — | Jun 14, 2023 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8278485 | Jun 08, 2027 | in 1 yr | SubstanceU-1993 |
| 8076515 | Dec 10, 2028 | in 2 yr 6 mo | SubstanceProductU-1993 |
| 8283380 | Mar 21, 2031 | in 4 yr 10 mo | U-1993 |
Safinamide mesylate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
