FDA Orange Book · active-ingredient family
Levomilnacipran hydrochloride
Levomilnacipran hydrochloride 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:FETZIMA · NDA 204168
1
Brand (NDA)
4
Generics (ANDA)
3
Listed patents
4
Exclusivity periods
Brand (NDA) products · capsule, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FETZIMARLD×4 | ABBVIE | NDA 204168 | AB | Jul 25, 2013 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LEVOMILNACIPRAN HYDROCHLORIDE×4 | PRINSTON INC | ANDA 210771 | AB | Mar 20, 2023 | |
| LEVOMILNACIPRAN HYDROCHLORIDE×4 | AUROBINDO PHARMA LTD | ANDA 210826 | — | Jan 06, 2023 | |
| LEVOMILNACIPRAN HYDROCHLORIDE×4 | HIKMA | ANDA 210732 | — | Nov 05, 2020 | |
| LEVOMILNACIPRAN HYDROCHLORIDE×4 | AMNEAL PHARMS CO | ANDA 210790 | — | Feb 04, 2019 |
Marketing exclusivity (4)
- M-304New use / labeling-change exclusivity (3 years)
Mar 24, 2026
3 mo ago
- M-304New use / labeling-change exclusivity (3 years)
Mar 24, 2026
3 mo ago
- M-304New use / labeling-change exclusivity (3 years)
Mar 24, 2026
3 mo ago
- M-304New use / labeling-change exclusivity (3 years)
Mar 24, 2026
3 mo ago
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| RE43879 | Jan 11, 2026 | 5 mo ago | U-839 |
| 8481598 | Mar 02, 2031 | in 4 yr 9 mo | U-839 |
| 8865937 | May 23, 2032 | in 6 yr | SubstanceProduct |
Levomilnacipran hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
