zuranolone · Biogen · NDA 217369
Zurzuvae
Earliest generic entry, as listed · earliest of 3 marketed strengths
23 Aug 2037
Blocked by patent: US 11236121, US 11884696.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11236121 | drug substance · sets the listed date | 23 Aug 2037 |
| US 11884696 | use U-2552 · sets the listed date | 23 Aug 2037 |
| US 10172871 | use U-2552 | 17 Apr 2034 |
| US 10342810 | use U-2552 | 17 Apr 2034 |
| US 9512165 | drug substance, drug product | 17 Apr 2034 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 31 Oct 2028 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 217369 · 001 · RLD | capsule, oral | 20MG | 23 Aug 2037 |
| 217369 · 002 · RLD | capsule, oral | 25MG | 23 Aug 2037 |
| 217369 · 003 · RLD | capsule, oral | 30MG | 23 Aug 2037 |