FDA Orange Book
Is there a generic for Quviviq?
Quviviq contains daridorexant. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Quviviq (daridorexant). The Orange Book shows its last listed patent expires December 2, 2034 and its last listed exclusivity ends September 30, 2027.
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Quviviq products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 25MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 50MG BASE | Marketed (Rx) | None | 0 | None |
NDA 214985, held by IDORSIA PHARMACEUTICALS LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Quviviq patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9732075 | June 3, 2033 | Drug substance, Drug product | U-620 | 214985 |
| 10023560 | December 2, 2034 | Method of use | U-620 | 214985 |
| 9790208 | December 2, 2034 | Drug substance, Drug product | None | 214985 |
Quviviq exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | April 7, 2027 | 214985 |
| M-200 | Miscellaneous | September 30, 2027 | 214985 |
| M-310 | Miscellaneous | September 30, 2027 | 214985 |
Quviviq NDC codes
Questions
Is there a generic for Quviviq?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Quviviq (daridorexant). The Orange Book shows its last listed patent expires December 2, 2034 and its last listed exclusivity ends September 30, 2027.
What is the generic name for Quviviq?
The active ingredient in Quviviq is daridorexant, per the FDA Orange Book.
When does the Quviviq patent expire?
The last patent listed for Quviviq in the Orange Book expires December 2, 2034. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.