FDA Orange Book · active-ingredient family
Daridorexant hydrochloride
Daridorexant hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:QUVIVIQ · NDA 214985
1
Brand (NDA)
0
Generics (ANDA)
3
Listed patents
6
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| QUVIVIQRLD×2 | IDORSIA | NDA 214985 | — | Apr 07, 2022 |
Marketing exclusivity (6)
- 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
- 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
- NCENew chemical entity exclusivity (5 years)
Apr 07, 2027
in 10 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 |
Daridorexant hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
