Application 217026

Type: NDA
Sponsor: ACADIA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DAYBUE	TROFINETIDE	SOLUTION;ORAL	200MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N217026-001	DAYBUE	TROFINETIDE	200MG/ML	SOLUTION / ORAL		RLD, RS	2023-03-10

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217026-001	9212204	2032-01-27	U-3556		2023-04-07
N217026-001	9212204*PED	2032-07-27		Pediatric extension
N217026-001	11370755	2040-08-03		Drug substance, Drug product	2023-04-07
N217026-001	11370755*PED	2041-02-03		Pediatric extension
N217026-001	11827600	2042-07-12	U-3556	Drug substance, Drug product	2024-08-12
N217026-001	12492167	2042-07-12	U-3556	Drug substance, Drug product	2026-01-08
N217026-001	11827600*PED	2043-01-12		Pediatric extension
N217026-001	12492167*PED	2043-01-12		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217026-001	NCE	2028-03-10
N217026-001	PED	2028-09-10
N217026-001	ODE-425	2030-03-10
N217026-001	PED	2030-09-10

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217026-001	DAYBUE	200MG/ML	SOLUTION / ORAL	RLD, RS	2023-03-10	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 79 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	N217026-001	9212204	2032-01-27	U-3556		2023-04-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217026-001	9212204*PED	2032-07-27		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217026-001	11370755	2040-08-03		Drug substance, Drug product	2023-04-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217026-001	11370755*PED	2041-02-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217026-001	11827600	2042-07-12	U-3556	Drug substance, Drug product	2024-08-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217026-001	12492167	2042-07-12	U-3556	Drug substance, Drug product	2026-01-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217026-001	11827600*PED	2043-01-12		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217026-001	12492167*PED	2043-01-12		Pediatric extension		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217026-001	9212204	2032-01-27	U-3556		2023-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217026-001	9212204*PED	2032-07-27		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217026-001	11370755	2040-08-03		Drug substance, Drug product	2023-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217026-001	11370755*PED	2041-02-03		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217026-001	11827600	2042-07-12	U-3556	Drug substance, Drug product	2024-08-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217026-001	12492167	2042-07-12	U-3556	Drug substance, Drug product	2026-01-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217026-001	11827600*PED	2043-01-12		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217026-001	12492167*PED	2043-01-12		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217026-001	9212204	2032-01-27	U-3556		2023-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217026-001	11370755	2040-08-03		Drug substance, Drug product	2023-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217026-001	11827600	2042-07-12	U-3556	Drug substance, Drug product	2024-08-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217026-001	12492167	2042-07-12	U-3556	Drug substance, Drug product	2026-01-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217026-001	9212204	2032-01-27	U-3556		2023-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217026-001	11370755	2040-08-03		Drug substance, Drug product	2023-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217026-001	11827600	2042-07-12	U-3556	Drug substance, Drug product	2024-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217026-001	9212204	2032-01-27	U-3556		2023-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217026-001	11370755	2040-08-03		Drug substance, Drug product	2023-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217026-001	11827600	2042-07-12	U-3556	Drug substance, Drug product	2024-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217026-001	9212204	2032-01-27	U-3556		2023-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217026-001	11370755	2040-08-03		Drug substance, Drug product	2023-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217026-001	11827600	2042-07-12	U-3556	Drug substance, Drug product	2024-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217026-001	9212204	2032-01-27	U-3556		2023-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217026-001	11370755	2040-08-03		Drug substance, Drug product	2023-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217026-001	11827600	2042-07-12	U-3556	Drug substance, Drug product	2024-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217026-001	9212204	2032-01-27	U-3556		2023-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217026-001	11370755	2040-08-03		Drug substance, Drug product	2023-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217026-001	11827600	2042-07-12	U-3556	Drug substance, Drug product	2024-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217026-001	9212204	2032-01-27	U-3556		2023-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217026-001	11370755	2040-08-03		Drug substance, Drug product	2023-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217026-001	11827600	2042-07-12	U-3556	Drug substance, Drug product	2024-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217026-001	9212204	2032-01-27	U-3556		2023-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217026-001	11370755	2040-08-03		Drug substance, Drug product	2023-04-07	`5bbf6a4d5a75…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 55 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N217026-001	NCE	2028-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217026-001	PED	2028-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217026-001	ODE-425	2030-03-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217026-001	PED	2030-09-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217026-001	NCE	2028-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217026-001	PED	2028-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217026-001	ODE-425	2030-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217026-001	PED	2030-09-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217026-001	NCE	2028-03-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217026-001	ODE-425	2030-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217026-001	NCE	2028-03-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217026-001	ODE-425	2030-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217026-001	NCE	2028-03-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217026-001	ODE-425	2030-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217026-001	NCE	2028-03-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217026-001	ODE-425	2030-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217026-001	NCE	2028-03-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217026-001	ODE-425	2030-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217026-001	NCE	2028-03-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217026-001	ODE-425	2030-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217026-001	NCE	2028-03-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217026-001	ODE-425	2030-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217026-001	NCE	2028-03-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217026-001	ODE-425	2030-03-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217026-001	NCE	2028-03-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217026-001	ODE-425	2030-03-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217026-001	NCE	2028-03-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217026-001	ODE-425	2030-03-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217026-001	NCE	2028-03-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217026-001	ODE-425	2030-03-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217026-001	NCE	2028-03-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217026-001	ODE-425	2030-03-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217026-001	NCE	2028-03-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217026-001	ODE-425	2030-03-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217026-001	NCE	2028-03-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N217026-001	ODE-425	2030-03-10	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217026-001	NCE	2028-03-10	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217026-001	ODE-425	2030-03-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217026-001	NCE	2028-03-10	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N217026-001	ODE-425	2030-03-10	`1c564ffb4f44…`

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): 217026 application number: NDA217026

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
85605	SUPPL	2026-03-31
85573	SUPPL	2026-03-30
83130	SUPPL	2025-08-19
83129	SUPPL	2025-08-19
83056	SUPPL	2025-08-06
83055	SUPPL	2025-08-06
79798	SUPPL	2024-10-03
79799	SUPPL	2024-10-02
79787	SUPPL	2024-10-01
79786	SUPPL	2024-10-01
73952	ORIG	2023-04-06
73740	ORIG	2023-03-30
73738	ORIG	2023-03-13