FDA Orange Book
Generic for Fetzima
Fetzima contains levomilnacipran. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Fetzima is levomilnacipran. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Fetzima products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | EQ 120MG BASE | Marketed (Rx) | AB | 1 | AB |
| capsule, extended release, oral | EQ 20MG BASE | Marketed (Rx) | AB | 1 | AB |
| capsule, extended release, oral | EQ 40MG BASE | Marketed (Rx) | AB | 1 | AB |
| capsule, extended release, oral | EQ 80MG BASE | Marketed (Rx) | AB | 1 | AB |
NDA 204168, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic levomilnacipran
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PRINSTON PHARMACEUTICAL INC | 210771 | AB (A-rated, therapeutically equivalent) | March 20, 2023 | EQ 120MG BASE, EQ 20MG BASE, EQ 40MG BASE, EQ 80MG BASE |
Fetzima patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| RE43879 | January 11, 2026 | Method of use | U-839 | 204168 |
| 8481598 | March 2, 2031 | Method of use | U-839 | 204168 |
| 8865937 | May 23, 2032 | Drug substance, Drug product | None | 204168 |
Fetzima exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-304 | Miscellaneous | March 24, 2026 | 204168 |
Fetzima NDC codes
Questions
Is there a generic for Fetzima?
Yes. The generic name for Fetzima is levomilnacipran. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Fetzima?
The active ingredient in Fetzima is levomilnacipran, per the FDA Orange Book.
When does the Fetzima patent expire?
The last patent listed for Fetzima in the Orange Book expires May 23, 2032. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.