DAYBUE STIX — FDA application NDA219884
Listed sponsor: ACADIA PHARMS INC · ACAD company profile · 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 STIX | TROFINETIDE | FOR SOLUTION | ORAL | 5000MG/PACKET | Prescription | not listed | Yes |
| 002 | DAYBUE STIX | TROFINETIDE | FOR SOLUTION | ORAL | 6000MG/PACKET | Prescription | not listed | Yes |
| 003 | DAYBUE STIX | TROFINETIDE | FOR SOLUTION | ORAL | 8000MG/PACKET | Prescription | not listed | Yes |
| 004 | DAYBUE STIX | TROFINETIDE | SOLUTION | ORAL | 10,000MG | Prescription | not listed | not listed |
| 005 | DAYBUE STIX | TROFINETIDE | SOLUTION | ORAL | 12,000MG | Prescription | not listed | not listed |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 9212204 | 001 | listed patent expiry date: 2032-01-27 | U-3556 |
| Patent 9212204 | 002 | listed patent expiry date: 2032-01-27 | U-3556 |
| Patent 9212204 | 003 | listed patent expiry date: 2032-01-27 | U-3556 |
| Patent 9212204 | 001 | listed patent expiry date: 2032-07-27 | pediatric extension |
| Patent 9212204 | 002 | listed patent expiry date: 2032-07-27 | pediatric extension |
| Patent 9212204 | 003 | listed patent expiry date: 2032-07-27 | pediatric extension |
| Patent 11370755 | 001 | listed patent expiry date: 2040-08-03 | drug substance, drug product |
| Patent 11370755 | 002 | listed patent expiry date: 2040-08-03 | drug substance, drug product |
| Patent 11370755 | 003 | listed patent expiry date: 2040-08-03 | drug substance, drug product |
| Patent 11370755 | 001 | listed patent expiry date: 2041-02-03 | pediatric extension |
| Patent 11370755 | 002 | listed patent expiry date: 2041-02-03 | pediatric extension |
| Patent 11370755 | 003 | listed patent expiry date: 2041-02-03 | pediatric extension |
| Patent 11827600 | 001 | listed patent expiry date: 2042-07-12 | drug substance, drug product, U-3556 |
| Patent 11827600 | 002 | listed patent expiry date: 2042-07-12 | drug substance, drug product, U-3556 |
| Patent 11827600 | 003 | listed patent expiry date: 2042-07-12 | drug substance, drug product, U-3556 |
| Patent 12492167 | 001 | listed patent expiry date: 2042-07-12 | drug substance, drug product, U-3556 |
| Patent 12492167 | 002 | listed patent expiry date: 2042-07-12 | drug substance, drug product, U-3556 |
| Patent 12492167 | 003 | listed patent expiry date: 2042-07-12 | drug substance, drug product, U-3556 |
| Patent 11827600 | 001 | listed patent expiry date: 2043-01-12 | pediatric extension |
| Patent 11827600 | 002 | listed patent expiry date: 2043-01-12 | pediatric extension |
| Patent 11827600 | 003 | listed patent expiry date: 2043-01-12 | pediatric extension |
| Patent 12492167 | 001 | listed patent expiry date: 2043-01-12 | pediatric extension |
| Patent 12492167 | 002 | listed patent expiry date: 2043-01-12 | pediatric extension |
| Patent 12492167 | 003 | listed patent expiry date: 2043-01-12 | pediatric extension |
| Exclusivity NCE | 001 | listed exclusivity date: 2028-03-10 | FDA code as listed |
| Exclusivity NCE | 002 | listed exclusivity date: 2028-03-10 | FDA code as listed |
| Exclusivity NCE | 003 | listed exclusivity date: 2028-03-10 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2028-09-10 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2028-09-10 | FDA code as listed |
| Exclusivity PED | 003 | listed exclusivity date: 2028-09-10 | FDA code as listed |
| Exclusivity ODE* | 001 | listed exclusivity date: 2030-03-10 | FDA code as listed |
| Exclusivity ODE* | 002 | listed exclusivity date: 2030-03-10 | FDA code as listed |
| Exclusivity ODE* | 003 | listed exclusivity date: 2030-03-10 | FDA code as listed |
| Exclusivity PED | 001 | listed exclusivity date: 2030-09-10 | FDA code as listed |
| Exclusivity PED | 002 | listed exclusivity date: 2030-09-10 | FDA code as listed |
| Exclusivity PED | 003 | listed exclusivity date: 2030-09-10 | FDA code as listed |
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 · FDA-approved application index
Peer clusters: No published peer-cluster link for this sponsor.
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.