phenobarbital sodium · Sun Pharm Inds Inc · NDA 215910
Sezaby
Earliest generic entry, as listed
7 Apr 2042
Blocked by patent: US 11857683, US 12636254.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11857683 | drug product, use U-3779 · sets the listed date | 7 Apr 2042 |
| US 12636254 | drug product, use U-3779 · sets the listed date | 7 Apr 2042 |
Exclusivities · 1 unexpired
| ODE-414 | orphan drug (7 years) | 17 Nov 2029 |
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 |
|---|---|---|---|
| 215910 · 001 · RLD | powder, intravenous | 100MG/VIAL | 7 Apr 2042 |