Application 219666

Type: NDA
Sponsor: PTC THERAP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SEPHIENCE	SEPIAPTERIN	POWDER;ORAL	250MG/PACKET	Yes	No
002	SEPHIENCE	SEPIAPTERIN	POWDER;ORAL	1GM/PACKET	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N219666-001	SEPHIENCE	SEPIAPTERIN	250MG/PACKET	POWDER / ORAL		RLD	2025-07-28
N219666-002	SEPHIENCE	SEPIAPTERIN	1GM/PACKET	POWDER / ORAL		RLD, RS	2025-07-28

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
N219666-001	11072614	2038-04-16	U-4251	Drug substance	2025-08-26
N219666-001	11752154	2038-09-04	U-4251	Drug product	2025-08-26
N219666-001	12213982	2038-09-04	U-4251		2025-08-26
N219666-001	12257252	2042-03-06	U-4250		2025-08-26
N219666-002	11072614	2038-04-16	U-4251	Drug substance	2025-08-26
N219666-002	11752154	2038-09-04	U-4251	Drug product	2025-08-26
N219666-002	12213982	2038-09-04	U-4251		2025-08-26
N219666-002	12257252	2042-03-06	U-4250		2025-08-26

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219666-001	NCE	2030-07-28
N219666-001	ODE-542	2032-07-28
N219666-002	NCE	2030-07-28
N219666-002	ODE-542	2032-07-28

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
2026-02-19 14:30 UTC	2026-02	N219666-001	SEPHIENCE	250MG/PACKET	POWDER / ORAL	RLD	2025-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219666-002	SEPHIENCE	1GM/PACKET	POWDER / ORAL	RLD, RS	2025-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-001	SEPHIENCE	250MG/PACKET	POWDER / ORAL	RLD	2025-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-002	SEPHIENCE	1GM/PACKET	POWDER / ORAL	RLD, RS	2025-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219666-001	SEPHIENCE	250MG/PACKET	POWDER / ORAL	RLD	2025-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219666-002	SEPHIENCE	1GM/PACKET	POWDER / ORAL	RLD, RS	2025-07-28	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-001	SEPHIENCE	250MG/PACKET	POWDER / ORAL	RLD	2025-07-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-002	SEPHIENCE	1GM/PACKET	POWDER / ORAL	RLD, RS	2025-07-28	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219666-001	11072614	2038-04-16	U-4251	Drug substance	2025-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219666-001	11752154	2038-09-04	U-4251	Drug product	2025-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219666-001	12213982	2038-09-04	U-4251		2025-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219666-001	12257252	2042-03-06	U-4250		2025-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219666-002	11072614	2038-04-16	U-4251	Drug substance	2025-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219666-002	11752154	2038-09-04	U-4251	Drug product	2025-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219666-002	12213982	2038-09-04	U-4251		2025-08-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219666-002	12257252	2042-03-06	U-4250		2025-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-001	11072614	2038-04-16	U-4251	Drug substance	2025-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-001	11752154	2038-09-04	U-4251	Drug product	2025-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-001	12213982	2038-09-04	U-4251		2025-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-001	12257252	2042-03-06	U-4250		2025-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-002	11072614	2038-04-16	U-4251	Drug substance	2025-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-002	11752154	2038-09-04	U-4251	Drug product	2025-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-002	12213982	2038-09-04	U-4251		2025-08-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-002	12257252	2042-03-06	U-4250		2025-08-26	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-001	11072614	2038-04-16	U-4251	Drug substance	2025-08-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-001	11752154	2038-09-04	U-4251	Drug product	2025-08-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-001	12213982	2038-09-04	U-4251		2025-08-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-001	12257252	2042-03-06	U-4250		2025-08-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-002	11072614	2038-04-16	U-4251	Drug substance	2025-08-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-002	11752154	2038-09-04	U-4251	Drug product	2025-08-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-002	12213982	2038-09-04	U-4251		2025-08-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-002	12257252	2042-03-06	U-4250		2025-08-26	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219666-001	NCE	2030-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219666-002	NCE	2030-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-001	NCE	2030-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219666-002	NCE	2030-07-28	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-001	NCE	2030-07-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-001	ODE-542	2032-07-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-002	NCE	2030-07-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219666-002	ODE-542	2032-07-28	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sephience	SEPIAPTERIN	PTC Therapeutics Inc.	32ac719c-49f0-4105-9c46-18c19583a5c2	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219666 application number: NDA219666
Sephience	SEPIAPTERIN	allphamed Pharbil Arzneimittel GmbH	9fabfee2-9488-4d03-b203-8fa50f9a7f55	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219666 application number: NDA219666

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83247	ORIG	2025-09-02
82983	ORIG	2025-07-29
82972	ORIG	2025-07-29