cenobamate · Sk Life · NDA 212839
Xcopri
Earliest generic entry, as listed · earliest of 6 marketed strengths
16 Jun 2039
Blocked by patent: US 11654133. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11654133 | use U-3610 | 16 Jun 2039 |
| US 7598279 | substance | 30 Oct 2032 |
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
- 25 Oct 2026Generic tentatively approved · 212839-00128 Apr 2026
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 212839 · 001 · RLD | tablet, oral | 12.5MG | 16 Jun 2039 |
| 212839 · 002 · RLD | tablet, oral | 25MG | 16 Jun 2039 |
| 212839 · 003 · RLD | tablet, oral | 50MG | 16 Jun 2039 |
| 212839 · 004 · RLD | tablet, oral | 100MG | 16 Jun 2039 |
| 212839 · 005 · RLD | tablet, oral | 150MG | 16 Jun 2039 |
| 212839 · 006 · RLD | tablet, oral | 200MG | 16 Jun 2039 |