FDA Orange Book
Is there a generic for Daybue?
Daybue contains trofinetide. 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 Daybue (trofinetide). The Orange Book shows its last listed patent expires January 12, 2043 and its last listed exclusivity ends September 10, 2030.
Run it in Rivvi
Map Daybue and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Daybue products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 200MG/ML | Marketed (Rx) | None | 0 | None |
NDA 217026, held by ACADIA PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Daybue patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9212204 | January 27, 2032 | Method of use | U-3556 | 217026 |
| 9212204*PED | July 27, 2032 | Method of use | None | 217026 |
| 11370755 | August 3, 2040 | Drug substance, Drug product | None | 217026 |
| 11370755*PED | February 3, 2041 | Method of use | None | 217026 |
| 12492167 | July 12, 2042 | Drug substance, Drug product | U-3556 | 217026 |
| 11827600 | July 12, 2042 | Drug substance, Drug product | U-3556 | 217026 |
| 11827600*PED | January 12, 2043 | Method of use | None | 217026 |
| 12492167*PED | January 12, 2043 | Method of use | None | 217026 |
Daybue exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | March 10, 2028 | 217026 |
| PED | Pediatric exclusivity | September 10, 2028 | 217026 |
| ODE-425 | Orphan drug exclusivity | March 10, 2030 | 217026 |
| PED | Pediatric exclusivity | September 10, 2030 | 217026 |
Daybue NDC codes
Questions
Is there a generic for Daybue?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Daybue (trofinetide). The Orange Book shows its last listed patent expires January 12, 2043 and its last listed exclusivity ends September 10, 2030.
What is the generic name for Daybue?
The active ingredient in Daybue is trofinetide, per the FDA Orange Book.
When does the Daybue patent expire?
The last patent listed for Daybue in the Orange Book expires January 12, 2043. 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.