ZURZUVAE — FDA application NDA217369
Listed sponsor: BIOGEN · BIIB company profile · 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 |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 10172871 | 001 | listed patent expiry date: 2034-04-17 | U-2552 |
| Patent 10172871 | 002 | listed patent expiry date: 2034-04-17 | U-2552 |
| Patent 10172871 | 003 | listed patent expiry date: 2034-04-17 | U-2552 |
| Patent 10342810 | 001 | listed patent expiry date: 2034-04-17 | U-2552 |
| Patent 10342810 | 002 | listed patent expiry date: 2034-04-17 | U-2552 |
| Patent 10342810 | 003 | listed patent expiry date: 2034-04-17 | U-2552 |
| Patent 9512165 | 001 | listed patent expiry date: 2034-04-17 | drug substance, drug product |
| Patent 9512165 | 002 | listed patent expiry date: 2034-04-17 | drug substance, drug product |
| Patent 9512165 | 003 | listed patent expiry date: 2034-04-17 | drug substance, drug product |
| Patent 11236121 | 001 | listed patent expiry date: 2037-08-23 | drug substance |
| Patent 11236121 | 002 | listed patent expiry date: 2037-08-23 | drug substance |
| Patent 11236121 | 003 | listed patent expiry date: 2037-08-23 | drug substance |
| Patent 11884696 | 001 | listed patent expiry date: 2037-08-23 | U-2552 |
| Patent 11884696 | 002 | listed patent expiry date: 2037-08-23 | U-2552 |
| Patent 11884696 | 003 | listed patent expiry date: 2037-08-23 | U-2552 |
| Exclusivity NCE | 001 | listed exclusivity date: 2028-10-31 | FDA code as listed |
| Exclusivity NCE | 002 | listed exclusivity date: 2028-10-31 | FDA code as listed |
| Exclusivity NCE | 003 | listed exclusivity date: 2028-10-31 | FDA code as listed |
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 · CHEMBL4105630
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: No published peer-cluster link for this sponsor.
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.