Orange Book product · Brand (NDA)
FETZIMA
LEVOMILNACIPRAN HYDROCHLORIDE
At a glance
Jul 25, 2013
Approved
Brand (NDA)
Application
AB
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 25, 2013
13 yr 1 mo ago
Patent RE43879 expires
Listed method-of-use patent (U-839) expiration.
Jan 11, 2026
5 mo ago
Exclusivity ends · M-304
New use / labeling-change exclusivity (3 years)
Mar 24, 2026
3 mo ago
Today
Patent 8481598 expires
Listed method-of-use patent (U-839) expiration.
Mar 02, 2031
in 4 yr 9 mo
Patent 8865937 expires
Listed drug substance patent expiration.
May 23, 2032
in 6 yr
Pharmaceutical detail
Active ingredient
LEVOMILNACIPRAN HYDROCHLORIDE
Strength
EQ 40MG BASE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
NDA 204168
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- 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 |
