FDA Orange Book
Is there a generic for Daybue Stix?
Daybue Stix 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 Stix (trofinetide). The Orange Book shows its last listed patent expires January 12, 2043 and its last listed exclusivity ends September 10, 2030.
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Daybue Stix products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for solution, oral | 5000MG/PACKET | Marketed (Rx) | None | 0 | None |
| for solution, oral | 6000MG/PACKET | Marketed (Rx) | None | 0 | None |
| for solution, oral | 8000MG/PACKET | Marketed (Rx) | None | 0 | None |
NDA 219884, 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 Stix patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9212204 | January 27, 2032 | Method of use | U-3556 | 219884 |
| 9212204*PED | July 27, 2032 | Method of use | None | 219884 |
| 11370755 | August 3, 2040 | Drug substance, Drug product | None | 219884 |
| 11370755*PED | February 3, 2041 | Method of use | None | 219884 |
| 12492167 | July 12, 2042 | Drug substance, Drug product | U-3556 | 219884 |
| 11827600 | July 12, 2042 | Drug substance, Drug product | U-3556 | 219884 |
| 12492167*PED | January 12, 2043 | Method of use | None | 219884 |
| 11827600*PED | January 12, 2043 | Method of use | None | 219884 |
Daybue Stix exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | March 10, 2028 | 219884 |
| PED | Pediatric exclusivity | September 10, 2028 | 219884 |
| ODE* | See the Orange Book exclusivity code list | March 10, 2030 | 219884 |
| PED | Pediatric exclusivity | September 10, 2030 | 219884 |
Daybue Stix NDC codes
Questions
Is there a generic for Daybue Stix?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Daybue Stix (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 Stix?
The active ingredient in Daybue Stix is trofinetide, per the FDA Orange Book.
When does the Daybue Stix patent expire?
The last patent listed for Daybue Stix 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.