Orange Book product · Brand (NDA)
DAYVIGO
LEMBOREXANT
At a glance
Apr 07, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 07, 2020
6 yr 3 mo ago
Exclusivity ends · M-293
New use / labeling-change exclusivity (3 years)
Apr 20, 2026
2 mo ago
Today
Patent 8268848 expires
Listed drug substance patent expiration.
Sep 20, 2031
in 5 yr 4 mo
Patent 10188652 expires
Listed drug product patent expiration.
Oct 21, 2035
in 9 yr 6 mo
Patent 10702529 expires
Listed drug product patent expiration.
Oct 21, 2035
in 9 yr 6 mo
Patent 11026944 expires
Listed drug product patent expiration.
Oct 21, 2035
in 9 yr 6 mo
Pharmaceutical detail
Active ingredient
LEMBOREXANT
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 212028
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- M-293New use / labeling-change exclusivity (3 years)
Apr 20, 2026
2 mo ago
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8268848 | Sep 20, 2031 | in 5 yr 4 mo | SubstanceProductU-2791 |
| 10188652 | Oct 21, 2035 | in 9 yr 6 mo | ProductU-2791 |
| 10702529 | Oct 21, 2035 | in 9 yr 6 mo | Product |
| 11026944 | Oct 21, 2035 | in 9 yr 6 mo | Product |
