# FETZIMA — FDA application NDA204168

Informational only - not investment advice.

Application NDA204168 · type NDA · FDA status: approved · original approval 2013-07-25

Listed sponsor: ABBVIE · [ABBV company profile](/company/ABBV/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | FETZIMA | LEVOMILNACIPRAN HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE | ORAL | EQ 20MG BASE | Prescription | AB | Yes |
| 002 | FETZIMA | LEVOMILNACIPRAN HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE | ORAL | EQ 40MG BASE | Prescription | AB | Yes |
| 003 | FETZIMA | LEVOMILNACIPRAN HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE | ORAL | EQ 80MG BASE | Prescription | AB | Yes |
| 004 | FETZIMA | LEVOMILNACIPRAN HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE | ORAL | EQ 120MG BASE | Prescription | AB | Yes |

## Orange Book patent and exclusivity listings

- Patent RE43879, product 001; listed patent expiry date: 2026-01-11.
- Patent RE43879, product 002; listed patent expiry date: 2026-01-11.
- Patent RE43879, product 003; listed patent expiry date: 2026-01-11.
- Patent RE43879, product 004; listed patent expiry date: 2026-01-11.
- Patent 8481598, product 001; listed patent expiry date: 2031-03-02.
- Patent 8481598, product 002; listed patent expiry date: 2031-03-02.
- Patent 8481598, product 003; listed patent expiry date: 2031-03-02.
- Patent 8481598, product 004; listed patent expiry date: 2031-03-02.
- Patent 8865937, product 001; listed patent expiry date: 2032-05-23.
- Patent 8865937, product 002; listed patent expiry date: 2032-05-23.
- Patent 8865937, product 003; listed patent expiry date: 2032-05-23.
- Patent 8865937, product 004; listed patent expiry date: 2032-05-23.
- Exclusivity M-304, product 001; listed exclusivity date: 2026-03-24.
- Exclusivity M-304, product 002; listed exclusivity date: 2026-03-24.
- Exclusivity M-304, product 003; listed exclusivity date: 2026-03-24.
- Exclusivity M-304, product 004; listed exclusivity date: 2026-03-24.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- LEVOMILNACIPRAN HYDROCHLORIDE · UNII 371U2ZK31U · [lmmol compound XNCDYJFPRPDERF-NQQJLSKUSA-N](https://lmmol.com/compound/XNCDYJFPRPDERF-NQQJLSKUSA-N)

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/ABBV/)
- [FDA-approved application index](/drug/)
- [Large-cap biopharma](/compare/pharma/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA204168. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.