Application 216956

Type: NDA
Sponsor: PFIZER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VELSIPITY	ETRASIMOD ARGININE	TABLET;ORAL	EQ 2MG BASE	Yes	Yes

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

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
N216956-001	VELSIPITY	ETRASIMOD ARGININE	EQ 2MG BASE	TABLET / ORAL		RLD, RS	2023-10-12

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216956-001	9126932	2029-07-22	U-3732		2023-11-09
N216956-001	8580841	2030-03-05		Drug substance, Drug product	2023-11-09
N216956-001	11007175	2036-01-06	U-3730		2023-11-09
N216956-001	12156866	2036-01-06	U-4047		2024-12-20
N216956-001	12377071	2036-01-06	U-4255		2025-09-03
N216956-001	10301262	2036-06-21		Drug substance, Drug product	2023-11-09
N216956-001	10676435	2036-06-21	U-3731		2023-11-09
N216956-001	11091435	2036-06-21		Drug substance, Drug product	2023-11-09
N216956-001	11884626	2036-06-21	U-3731		2024-02-28

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216956-001	NCE	2028-10-12

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	N216956-001	VELSIPITY	EQ 2MG BASE	TABLET / ORAL	RLD, RS	2023-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216956-001	VELSIPITY	EQ 2MG BASE	TABLET / ORAL	RLD, RS	2023-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216956-001	VELSIPITY	EQ 2MG BASE	TABLET / ORAL	RLD, RS	2023-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216956-001	VELSIPITY	EQ 2MG BASE	TABLET / ORAL	RLD, RS	2023-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216956-001	VELSIPITY	EQ 2MG BASE	TABLET / ORAL	RLD, RS	2023-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216956-001	VELSIPITY	EQ 2MG BASE	TABLET / ORAL	RLD, RS	2023-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216956-001	VELSIPITY	EQ 2MG BASE	TABLET / ORAL	RLD, RS	2023-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216956-001	VELSIPITY	EQ 2MG BASE	TABLET / ORAL	RLD, RS	2023-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216956-001	VELSIPITY	EQ 2MG BASE	TABLET / ORAL	RLD, RS	2023-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216956-001	VELSIPITY	EQ 2MG BASE	TABLET / ORAL	RLD, RS	2023-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216956-001	VELSIPITY	EQ 2MG BASE	TABLET / ORAL	RLD, RS	2023-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216956-001	VELSIPITY	EQ 2MG BASE	TABLET / ORAL	RLD, RS	2023-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216956-001	VELSIPITY	EQ 2MG BASE	TABLET / ORAL	RLD, RS	2023-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216956-001	VELSIPITY	EQ 2MG BASE	TABLET / ORAL	RLD, RS	2023-10-12	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216956-001	VELSIPITY	EQ 2MG BASE	TABLET / ORAL	RLD, RS	2023-10-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216956-001	VELSIPITY	EQ 2MG BASE	TABLET / ORAL	RLD, RS	2023-10-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216956-001	VELSIPITY	EQ 2MG BASE	TABLET / ORAL	RLD, RS	2023-10-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216956-001	VELSIPITY	EQ 2MG BASE	TABLET / ORAL	RLD, RS	2023-10-12	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216956-001	VELSIPITY	EQ 2MG BASE	TABLET / ORAL	RLD, RS	2023-10-12	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 134 observed states.

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	N216956-001	9126932	2029-07-22	U-3732		2023-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216956-001	8580841	2030-03-05		Drug substance, Drug product	2023-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216956-001	11007175	2036-01-06	U-3730		2023-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216956-001	12156866	2036-01-06	U-4047		2024-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216956-001	12377071	2036-01-06	U-4255		2025-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216956-001	10301262	2036-06-21		Drug substance, Drug product	2023-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216956-001	10676435	2036-06-21	U-3731		2023-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216956-001	11091435	2036-06-21		Drug substance, Drug product	2023-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216956-001	11884626	2036-06-21	U-3731		2024-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216956-001	9126932	2029-07-22	U-3732		2023-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216956-001	8580841	2030-03-05		Drug substance, Drug product	2023-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216956-001	11007175	2036-01-06	U-3730		2023-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216956-001	12156866	2036-01-06	U-4047		2024-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216956-001	12377071	2036-01-06	U-4255		2025-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216956-001	10301262	2036-06-21		Drug substance, Drug product	2023-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216956-001	10676435	2036-06-21	U-3731		2023-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216956-001	11091435	2036-06-21		Drug substance, Drug product	2023-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216956-001	11884626	2036-06-21	U-3731		2024-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216956-001	9126932	2029-07-22	U-3732		2023-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216956-001	8580841	2030-03-05		Drug substance, Drug product	2023-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216956-001	11007175	2036-01-06	U-3730		2023-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216956-001	12156866	2036-01-06	U-4047		2024-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216956-001	10301262	2036-06-21		Drug substance, Drug product	2023-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216956-001	10676435	2036-06-21	U-3731		2023-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216956-001	11091435	2036-06-21		Drug substance, Drug product	2023-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216956-001	11884626	2036-06-21	U-3731		2024-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216956-001	9126932	2029-07-22	U-3732		2023-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216956-001	8580841	2030-03-05		Drug substance, Drug product	2023-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216956-001	11007175	2036-01-06	U-3730		2023-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216956-001	12156866	2036-01-06	U-4047		2024-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216956-001	10301262	2036-06-21		Drug substance, Drug product	2023-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216956-001	10676435	2036-06-21	U-3731		2023-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216956-001	11091435	2036-06-21		Drug substance, Drug product	2023-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216956-001	11884626	2036-06-21	U-3731		2024-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216956-001	9126932	2029-07-22	U-3732		2023-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216956-001	8580841	2030-03-05		Drug substance, Drug product	2023-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216956-001	11007175	2036-01-06	U-3730		2023-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216956-001	12156866	2036-01-06	U-4047		2024-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216956-001	10301262	2036-06-21		Drug substance, Drug product	2023-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216956-001	10676435	2036-06-21	U-3731		2023-11-09	`b8a1b40f171c…`

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	N216956-001	NCE	2028-10-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216956-001	NCE	2028-10-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216956-001	NCE	2028-10-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216956-001	NCE	2028-10-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216956-001	NCE	2028-10-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216956-001	NCE	2028-10-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216956-001	NCE	2028-10-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216956-001	NCE	2028-10-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216956-001	NCE	2028-10-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216956-001	NCE	2028-10-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216956-001	NCE	2028-10-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216956-001	NCE	2028-10-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216956-001	NCE	2028-10-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216956-001	NCE	2028-10-12	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216956-001	NCE	2028-10-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216956-001	NCE	2028-10-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216956-001	NCE	2028-10-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216956-001	NCE	2028-10-12	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216956-001	NCE	2028-10-12	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Velsipity	ETRASIMOD	Pfizer Laboratories Div Pfizer Inc	65171e4a-d136-4abc-b08c-c40c1b486ff6	2025-08-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216956 application number: NDA216956

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83103	SUPPL	2025-08-15
83102	SUPPL	2025-08-15
83098	SUPPL	2025-08-13
78734	SUPPL	2024-07-02
78657	SUPPL	2024-06-06
76566	ORIG	2023-11-14
75729	ORIG	2023-10-13
75725	ORIG	2023-10-13
75724	ORIG	2023-10-13