diazepam · Neurelis Inc · NDA 211635
Valtoco
Earliest generic entry, as listed · earliest of 3 marketed strengths
10 Jun 2042
Blocked by patent: US 12599611. 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 12599611 | use U-4455 · sets the listed date | 10 Jun 2042 |
| US 12324852 | use U-4173 | 16 Oct 2032 |
| US 12337061 | use U-4173 | 13 Jun 2032 |
| US 11241414 | drug product | 27 Mar 2029 |
| US 11793786 | drug product | 27 Mar 2029 |
| US 12268664 | drug product | 27 Mar 2029 |
| US 12521400 | drug product | 27 Mar 2029 |
| US 8895546 | drug product | 27 Mar 2029 |
Exclusivities · 2 unexpired
| NPP | new patient population | 15 Apr 2028 |
| ODE-279 | orphan drug (7 years) | 10 Jan 2027 |
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
- 24 Oct 2026Exclusivity expires within 90 days ODE-279 · 211635-00310 Jan 2027
- 24 Oct 2026Exclusivity expires within 90 days ODE-279 · 211635-00210 Jan 2027
- 24 Oct 2026Exclusivity expires within 90 days ODE-279 · 211635-00110 Jan 2027
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 211635 · 001 · RLD | spray, nasal | 5MG/SPRAY | 10 Jun 2042 |
| 211635 · 002 · RLD | spray, nasal | 7.5MG/SPRAY | 10 Jun 2042 |
| 211635 · 003 · RLD | spray, nasal | 10MG/SPRAY | 10 Jun 2042 |