# ZURZUVAE — FDA application NDA217369

Informational only - not investment advice.

Application NDA217369 · type NDA · FDA status: approved · original approval 2023-08-04

Listed sponsor: BIOGEN · [BIIB company profile](/company/BIIB/) · 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 | ZURZUVAE | ZURANOLONE | CAPSULE | ORAL | 20MG | Prescription | not listed | Yes |
| 002 | ZURZUVAE | ZURANOLONE | CAPSULE | ORAL | 25MG | Prescription | not listed | Yes |
| 003 | ZURZUVAE | ZURANOLONE | CAPSULE | ORAL | 30MG | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 10172871, product 001; listed patent expiry date: 2034-04-17.
- Patent 10172871, product 002; listed patent expiry date: 2034-04-17.
- Patent 10172871, product 003; listed patent expiry date: 2034-04-17.
- Patent 10342810, product 001; listed patent expiry date: 2034-04-17.
- Patent 10342810, product 002; listed patent expiry date: 2034-04-17.
- Patent 10342810, product 003; listed patent expiry date: 2034-04-17.
- Patent 9512165, product 001; listed patent expiry date: 2034-04-17.
- Patent 9512165, product 002; listed patent expiry date: 2034-04-17.
- Patent 9512165, product 003; listed patent expiry date: 2034-04-17.
- Patent 11236121, product 001; listed patent expiry date: 2037-08-23.
- Patent 11236121, product 002; listed patent expiry date: 2037-08-23.
- Patent 11236121, product 003; listed patent expiry date: 2037-08-23.
- Patent 11884696, product 001; listed patent expiry date: 2037-08-23.
- Patent 11884696, product 002; listed patent expiry date: 2037-08-23.
- Patent 11884696, product 003; listed patent expiry date: 2037-08-23.
- Exclusivity NCE, product 001; listed exclusivity date: 2028-10-31.
- Exclusivity NCE, product 002; listed exclusivity date: 2028-10-31.
- Exclusivity NCE, product 003; listed exclusivity date: 2028-10-31.

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

- ZURANOLONE · UNII 7ZW49N180B · [lmmol compound HARRKNSQXBRBGZ-GVKWWOCJSA-N](https://lmmol.com/compound/HARRKNSQXBRBGZ-GVKWWOCJSA-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/BIIB/)
- [FDA-approved application index](/drug/)

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:NDA217369. FDA data retrieved 2026-08-07.

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