midazolam · Ucb Inc · NDA 211321
Nayzilam
Earliest generic entry, as listed
18 Jan 2028
Blocked by patent: US 8217033, US 8809322, US 9289432, US 9687495.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8217033 | drug product, use U-2526 · sets the listed date | 18 Jan 2028 |
| US 8809322 | drug product · sets the listed date | 18 Jan 2028 |
| US 9289432 | drug product, use U-2526 · sets the listed date | 18 Jan 2028 |
| US 9687495 | drug product, use U-2526 · sets the listed date | 18 Jan 2028 |
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 |
|---|---|---|---|
| 211321 · 001 · RLD | spray, nasal | 5MG/SPRAY | 18 Jan 2028 |
Expired or delisted (1)
- ODE-243 · 17 May 2026