# DAYBUE — FDA application NDA217026

Informational only - not investment advice.

Application NDA217026 · type NDA · FDA status: approved · original approval 2023-03-10

Listed sponsor: ACADIA PHARMS INC · [ACAD company profile](/company/ACAD/) · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

## FDA application facts

| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 001 | DAYBUE | TROFINETIDE | SOLUTION | ORAL | 200MG/ML | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 9212204, product 001; listed patent expiry date: 2032-01-27.
- Patent 9212204, product 001; listed patent expiry date: 2032-07-27.
- Patent 11370755, product 001; listed patent expiry date: 2040-08-03.
- Patent 11370755, product 001; listed patent expiry date: 2041-02-03.
- Patent 11827600, product 001; listed patent expiry date: 2042-07-12.
- Patent 12492167, product 001; listed patent expiry date: 2042-07-12.
- Patent 11827600, product 001; listed patent expiry date: 2043-01-12.
- Patent 12492167, product 001; listed patent expiry date: 2043-01-12.
- Exclusivity NCE, product 001; listed exclusivity date: 2028-03-10.
- Exclusivity PED, product 001; listed exclusivity date: 2028-09-10.
- Exclusivity ODE-425, product 001; listed exclusivity date: 2030-03-10.
- Exclusivity PED, product 001; listed exclusivity date: 2030-09-10.

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

## Compound cross-links

- TROFINETIDE · UNII Z2ME8F52QL · no lmmol compound match

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/ACAD/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA217026. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.