lemborexant · Eisai Inc · NDA 212028
Dayvigo
Earliest generic entry, as listed · earliest of 2 marketed strengths
21 Oct 2035
Blocked by patent: US 10188652, US 10702529, US 11026944.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10188652 | product, use U-2791 | 21 Oct 2035 |
| US 10702529 | product | 21 Oct 2035 |
| US 11026944 | product | 21 Oct 2035 |
| US 8268848 | substance, product, use U-2791 | 20 Sep 2031 |
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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 212028 · 001 · RLD | tablet, oral | 5MG | 21 Oct 2035 |
| 212028 · 002 · RLD | tablet, oral | 10MG | 21 Oct 2035 |
Expired or delisted (1)
- M-293 · 20 Apr 2026