daridorexant hydrochloride · Idorsia · NDA 214985
Quviviq
Earliest generic entry, as listed · earliest of 2 marketed strengths
2 Dec 2034
Blocked by patent: US 10023560, US 9790208.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10023560 | use U-620 · sets the listed date | 2 Dec 2034 |
| US 9790208 | drug substance, drug product · sets the listed date | 2 Dec 2034 |
| US 9732075 | drug substance, drug product, use U-620 | 3 Jun 2033 |
Exclusivities · 3 unexpired
| M-200 | miscellaneous (3 years) | 30 Sep 2027 |
| M-310 | miscellaneous (3 years) | 30 Sep 2027 |
| NCE | new chemical entity (5 years) | 7 Apr 2027 |
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 |
|---|---|---|---|
| 214985 · 001 · RLD | tablet, oral | EQ 25MG BASE | 2 Dec 2034 |
| 214985 · 002 · RLD | tablet, oral | EQ 50MG BASE | 2 Dec 2034 |