diazoxide choline · Soleno · NDA 216665
Vykat Xr
Earliest generic entry, as listed · earliest of 3 marketed strengths
12 Nov 2035
Blocked by patent: US 12178823, US 12343348, US 12419895, US 9757384. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12178823 | use U-4167 · sets the listed date | 12 Nov 2035 |
| US 12343348 | use U-4211 · sets the listed date | 12 Nov 2035 |
| US 12419895 | use U-4275 · sets the listed date | 12 Nov 2035 |
| US 9757384 | use U-4167 · sets the listed date | 12 Nov 2035 |
| US 7799777 | drug substance | 5 Mar 2029 |
| US 7572789 | drug substance, drug product | 20 Dec 2026 |
Exclusivities · 2 unexpired
| ODE-532 | orphan drug (7 years) | 26 Mar 2032 |
| NP | new product | 26 Mar 2028 |
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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216665 · 001 · RLD | tablet, extended release, oral | 25MG | 12 Nov 2035 |
| 216665 · 002 · RLD | tablet, extended release, oral | 75MG | 12 Nov 2035 |
| 216665 · 003 · RLD | tablet, extended release, oral | 150MG | 12 Nov 2035 |