Orange Book product · Brand (NDA)
QUVIVIQ
DARIDOREXANT HYDROCHLORIDE
At a glance
Apr 07, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 07, 2022
4 yr 3 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Apr 07, 2027
in 10 mo
Exclusivity ends · M-200
New use / labeling-change exclusivity (3 years)
Sep 30, 2027
in 1 yr 4 mo
Exclusivity ends · M-310
New use / labeling-change exclusivity (3 years)
Sep 30, 2027
in 1 yr 4 mo
Patent 9732075 expires
Listed drug substance patent expiration.
Jun 12, 2033
in 7 yr 1 mo
Patent 10023560 expires
Listed method-of-use patent (U-620) expiration.
Dec 02, 2034
in 8 yr 7 mo
Patent 9790208 expires
Listed drug substance patent expiration.
Dec 02, 2034
in 8 yr 7 mo
Pharmaceutical detail
Active ingredient
DARIDOREXANT HYDROCHLORIDE
Strength
EQ 25MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 214985
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 (3)
- NCENew chemical entity exclusivity (5 years)
Apr 07, 2027
in 10 mo
- M-200New use / labeling-change exclusivity (3 years)
Sep 30, 2027
in 1 yr 4 mo
- M-310New use / labeling-change exclusivity (3 years)
Sep 30, 2027
in 1 yr 4 mo
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9732075 | Jun 12, 2033 | in 7 yr 1 mo | SubstanceProductU-620 |
| 10023560 | Dec 02, 2034 | in 8 yr 7 mo | U-620 |
| 9790208 | Dec 02, 2034 | in 8 yr 7 mo | SubstanceProduct |
