Home Applications 219884 Application 219884
Type NDA
Sponsor ACADIA PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DAYBUE STIX TROFINETIDE FOR SOLUTION;ORAL 5000MG/PACKET Yes Yes 002 DAYBUE STIX TROFINETIDE FOR SOLUTION;ORAL 6000MG/PACKET Yes Yes 003 DAYBUE STIX TROFINETIDE FOR SOLUTION;ORAL 8000MG/PACKET Yes Yes 004 DAYBUE STIX TROFINETIDE SOLUTION; ORAL 10,000MG No No 005 DAYBUE STIX TROFINETIDE SOLUTION; ORAL 12,000MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219884-001 DAYBUE STIX TROFINETIDE 5000MG/PACKET FOR SOLUTION / ORAL RLD, RS 2025-12-11 N219884-002 DAYBUE STIX TROFINETIDE 6000MG/PACKET FOR SOLUTION / ORAL RLD, RS 2025-12-11 N219884-003 DAYBUE STIX TROFINETIDE 8000MG/PACKET FOR SOLUTION / ORAL RLD, RS 2025-12-11
Orange Book patents# Current patent rows page 1 of 1 · 24 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N219884-001 9212204 2032-01-27 U-3556 2026-01-08 N219884-001 9212204*PED 2032-07-27 Pediatric extension N219884-001 11370755 2040-08-03 Drug substance, Drug product 2026-01-08 N219884-001 11370755*PED 2041-02-03 Pediatric extension N219884-001 11827600 2042-07-12 U-3556 Drug substance, Drug product 2026-01-08 N219884-001 12492167 2042-07-12 U-3556 Drug substance, Drug product 2026-01-08 N219884-001 11827600*PED 2043-01-12 Pediatric extension N219884-001 12492167*PED 2043-01-12 Pediatric extension N219884-002 9212204 2032-01-27 U-3556 2026-01-08 N219884-002 9212204*PED 2032-07-27 Pediatric extension N219884-002 11370755 2040-08-03 Drug substance, Drug product 2026-01-08 N219884-002 11370755*PED 2041-02-03 Pediatric extension N219884-002 11827600 2042-07-12 U-3556 Drug substance, Drug product 2026-01-08 N219884-002 12492167 2042-07-12 U-3556 Drug substance, Drug product 2026-01-08 N219884-002 11827600*PED 2043-01-12 Pediatric extension N219884-002 12492167*PED 2043-01-12 Pediatric extension N219884-003 9212204 2032-01-27 U-3556 2026-01-08 N219884-003 9212204*PED 2032-07-27 Pediatric extension N219884-003 11370755 2040-08-03 Drug substance, Drug product 2026-01-08 N219884-003 11370755*PED 2041-02-03 Pediatric extension N219884-003 11827600 2042-07-12 U-3556 Drug substance, Drug product 2026-01-08 N219884-003 12492167 2042-07-12 U-3556 Drug substance, Drug product 2026-01-08 N219884-003 11827600*PED 2043-01-12 Pediatric extension N219884-003 12492167*PED 2043-01-12 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 12 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N219884-001 DAYBUE STIX 5000MG/PACKET FOR SOLUTION / ORAL RLD, RS 2025-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-002 DAYBUE STIX 6000MG/PACKET FOR SOLUTION / ORAL RLD, RS 2025-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-003 DAYBUE STIX 8000MG/PACKET FOR SOLUTION / ORAL RLD, RS 2025-12-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219884-001 DAYBUE STIX 5000MG/PACKET FOR SOLUTION / ORAL RLD, RS 2025-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219884-002 DAYBUE STIX 6000MG/PACKET FOR SOLUTION / ORAL RLD, RS 2025-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219884-003 DAYBUE STIX 8000MG/PACKET FOR SOLUTION / ORAL RLD, RS 2025-12-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N219884-001 DAYBUE STIX 5000MG/PACKET FOR SOLUTION / ORAL RLD, RS 2025-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219884-002 DAYBUE STIX 6000MG/PACKET FOR SOLUTION / ORAL RLD, RS 2025-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N219884-003 DAYBUE STIX 8000MG/PACKET FOR SOLUTION / ORAL RLD, RS 2025-12-11 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219884-001 DAYBUE STIX 5000MG/PACKET FOR SOLUTION / ORAL RLD, RS 2025-12-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219884-002 DAYBUE STIX 6000MG/PACKET FOR SOLUTION / ORAL RLD, RS 2025-12-11 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219884-003 DAYBUE STIX 8000MG/PACKET FOR SOLUTION / ORAL RLD, RS 2025-12-11 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N219884-001 9212204 2032-01-27 U-3556 2026-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-001 9212204*PED 2032-07-27 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-001 11370755 2040-08-03 Drug substance, Drug product 2026-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-001 11370755*PED 2041-02-03 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-001 11827600 2042-07-12 U-3556 Drug substance, Drug product 2026-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-001 12492167 2042-07-12 U-3556 Drug substance, Drug product 2026-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-001 11827600*PED 2043-01-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-001 12492167*PED 2043-01-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-002 9212204 2032-01-27 U-3556 2026-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-002 9212204*PED 2032-07-27 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-002 11370755 2040-08-03 Drug substance, Drug product 2026-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-002 11370755*PED 2041-02-03 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-002 11827600 2042-07-12 U-3556 Drug substance, Drug product 2026-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-002 12492167 2042-07-12 U-3556 Drug substance, Drug product 2026-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-002 11827600*PED 2043-01-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-002 12492167*PED 2043-01-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-003 9212204 2032-01-27 U-3556 2026-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-003 9212204*PED 2032-07-27 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-003 11370755 2040-08-03 Drug substance, Drug product 2026-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-003 11370755*PED 2041-02-03 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-003 11827600 2042-07-12 U-3556 Drug substance, Drug product 2026-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-003 12492167 2042-07-12 U-3556 Drug substance, Drug product 2026-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-003 11827600*PED 2043-01-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219884-003 12492167*PED 2043-01-12 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219884-001 9212204 2032-01-27 U-3556 2026-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219884-001 9212204*PED 2032-07-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219884-001 11370755 2040-08-03 Drug substance, Drug product 2026-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219884-001 11370755*PED 2041-02-03 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219884-001 11827600 2042-07-12 U-3556 Drug substance, Drug product 2026-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219884-001 12492167 2042-07-12 U-3556 Drug substance, Drug product 2026-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219884-001 11827600*PED 2043-01-12 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219884-001 12492167*PED 2043-01-12 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219884-002 9212204 2032-01-27 U-3556 2026-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219884-002 9212204*PED 2032-07-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219884-002 11370755 2040-08-03 Drug substance, Drug product 2026-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219884-002 11370755*PED 2041-02-03 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219884-002 11827600 2042-07-12 U-3556 Drug substance, Drug product 2026-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219884-002 12492167 2042-07-12 U-3556 Drug substance, Drug product 2026-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219884-002 11827600*PED 2043-01-12 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219884-002 12492167*PED 2043-01-12 Pediatric extension caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 42 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Daybue TROFINETIDE Acadia Pharmaceuticals Inc. 67e6f2d9-21f6-466f-9def-826c6a4b8257 2026-09-04 Warnings, Adverse reactions Exact identifier application applno (NDA): 219884 application number: NDA219884
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 84400 ORIG 2025-12-12