FDA Orange Book
Is there a generic for Dayvigo?
Dayvigo contains lemborexant. 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 Dayvigo (lemborexant). The Orange Book shows its last listed patent expires October 21, 2035 and its last listed exclusivity ends April 20, 2026.
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Dayvigo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 5MG | Marketed (Rx) | None | 0 | None |
NDA 212028, held by EISAI INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Dayvigo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8268848 | September 20, 2031 | Drug substance, Drug product | U-2791 | 212028 |
| 10188652 | October 21, 2035 | Drug product | U-2791 | 212028 |
| 11026944 | October 21, 2035 | Drug product | None | 212028 |
| 10702529 | October 21, 2035 | Drug product | None | 212028 |
Dayvigo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-293 | Miscellaneous | April 20, 2026 | 212028 |
Dayvigo NDC codes
Questions
Is there a generic for Dayvigo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Dayvigo (lemborexant). The Orange Book shows its last listed patent expires October 21, 2035 and its last listed exclusivity ends April 20, 2026.
What is the generic name for Dayvigo?
The active ingredient in Dayvigo is lemborexant, per the FDA Orange Book.
When does the Dayvigo patent expire?
The last patent listed for Dayvigo in the Orange Book expires October 21, 2035. 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.