brexanolone · Sage Therap Supernus · NDA 211371
Zulresso
Earliest generic entry, as listed
8 Mar 2037
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 10940156. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 8 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10940156 | use U-2552 · sets the listed date | 8 Mar 2037 |
| US 10251894 | use U-2552 | 27 Nov 2033 |
| US 10322139 | drug product | 23 Jan 2033 |
| US 10117951 | drug product | 13 Mar 2029 |
| US 7635773 | drug product | 13 Mar 2029 |
| US 8410077 | drug product | 13 Mar 2029 |
| US 9200088 | drug product | 13 Mar 2029 |
| US 9750822 | drug product | 13 Mar 2029 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 211371 · 001 · RLD · discontinued | solution, intravenous | 100MG/20ML (5MG/ML) | 8 Mar 2037 |