Application 214958

Type: NDA
Sponsor: BRISTOL-MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SOTYKTU	DEUCRAVACITINIB	TABLET; ORAL	6MG (3)	No	No

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
N214958-001	SOTYKTU	DEUCRAVACITINIB	6MG	TABLET / ORAL		RLD, RS	2022-09-09

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214958-001	10000480	2033-11-07		Drug substance, Drug product	2022-10-04
N214958-001	11021475	2033-11-07	U-3434		2022-10-04
N214958-001	RE47929	2033-11-07	U-3434	Drug substance, Drug product	2022-10-04
N214958-001	RE47929	2033-11-07	U-4452	Drug substance, Drug product	2022-10-04
N214958-001	12521390	2043-02-11	U-3434	Drug product	2026-02-09
N214958-001	12521390	2043-02-11	U-4451	Drug product	2026-02-09

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214958-001	NCE	2027-09-09
N214958-001	I-986	2029-03-06

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	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214958-001	SOTYKTU	6MG	TABLET / ORAL	RLD, RS	2022-09-09	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 82 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	N214958-001	10000480	2033-11-07		Drug substance, Drug product	2022-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214958-001	11021475	2033-11-07	U-3434		2022-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214958-001	RE47929	2033-11-07	U-3434	Drug substance, Drug product	2022-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214958-001	12521390	2043-02-11	U-3434	Drug product	2026-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214958-001	10000480	2033-11-07		Drug substance, Drug product	2022-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214958-001	11021475	2033-11-07	U-3434		2022-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214958-001	RE47929	2033-11-07	U-3434	Drug substance, Drug product	2022-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214958-001	10000480	2033-11-07		Drug substance, Drug product	2022-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214958-001	11021475	2033-11-07	U-3434		2022-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214958-001	RE47929	2033-11-07	U-3434	Drug substance, Drug product	2022-10-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214958-001	10000480	2033-11-07		Drug substance, Drug product	2022-10-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214958-001	11021475	2033-11-07	U-3434		2022-10-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214958-001	RE47929	2033-11-07	U-3434	Drug substance, Drug product	2022-10-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214958-001	10000480	2033-11-07		Drug substance, Drug product	2022-10-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214958-001	11021475	2033-11-07	U-3434		2022-10-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214958-001	RE47929	2033-11-07	U-3434	Drug substance, Drug product	2022-10-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214958-001	10000480	2033-11-07		Drug substance, Drug product	2022-10-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214958-001	11021475	2033-11-07	U-3434		2022-10-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214958-001	RE47929	2033-11-07	U-3434	Drug substance, Drug product	2022-10-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214958-001	10000480	2033-11-07		Drug substance, Drug product	2022-10-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214958-001	11021475	2033-11-07	U-3434		2022-10-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214958-001	RE47929	2033-11-07	U-3434	Drug substance, Drug product	2022-10-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214958-001	10000480	2033-11-07		Drug substance, Drug product	2022-10-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214958-001	11021475	2033-11-07	U-3434		2022-10-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214958-001	RE47929	2033-11-07	U-3434	Drug substance, Drug product	2022-10-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214958-001	10000480	2033-11-07		Drug substance, Drug product	2022-10-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214958-001	11021475	2033-11-07	U-3434		2022-10-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214958-001	RE47929	2033-11-07	U-3434	Drug substance, Drug product	2022-10-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214958-001	10000480	2033-11-07		Drug substance, Drug product	2022-10-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214958-001	11021475	2033-11-07	U-3434		2022-10-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214958-001	RE47929	2033-11-07	U-3434	Drug substance, Drug product	2022-10-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214958-001	10000480	2033-11-07		Drug substance, Drug product	2022-10-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214958-001	11021475	2033-11-07	U-3434		2022-10-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214958-001	RE47929	2033-11-07	U-3434	Drug substance, Drug product	2022-10-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214958-001	10000480	2033-11-07		Drug substance, Drug product	2022-10-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214958-001	11021475	2033-11-07	U-3434		2022-10-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214958-001	RE47929	2033-11-07	U-3434	Drug substance, Drug product	2022-10-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214958-001	10000480	2033-11-07		Drug substance, Drug product	2022-10-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214958-001	11021475	2033-11-07	U-3434		2022-10-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214958-001	RE47929	2033-11-07	U-3434	Drug substance, Drug product	2022-10-04	`1e350fbaab3a…`

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	N214958-001	NCE	2027-09-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214958-001	NCE	2027-09-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214958-001	NCE	2027-09-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214958-001	NCE	2027-09-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214958-001	NCE	2027-09-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214958-001	NCE	2027-09-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214958-001	NCE	2027-09-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214958-001	NCE	2027-09-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214958-001	NCE	2027-09-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214958-001	NCE	2027-09-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214958-001	NCE	2027-09-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214958-001	NCE	2027-09-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214958-001	NCE	2027-09-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214958-001	NCE	2027-09-09	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214958-001	NCE	2027-09-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214958-001	NCE	2027-09-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214958-001	NCE	2027-09-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214958-001	NCE	2027-09-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214958-001	NCE	2027-09-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214958-001	NCE	2027-09-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214958-001	NCE	2027-09-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214958-001	NCE	2027-09-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214958-001	NCE	2027-09-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214958-001	NCE	2027-09-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214958-001	NCE	2027-09-09	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214958-001	NCE	2027-09-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214958-001	I-986	2029-03-06	`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
SOTYKTU	DEUCRAVACITINIB	E.R. Squibb & Sons, L.L.C.	ff4d7258-5068-4cdf-9692-8cae04c3198e	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214958 application number: NDA214958 ndc (product): 0003-0895

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0003-0895	SOTYKTU	deucravacitinib	E.R. Squibb & Sons, L.L.C.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85341	SUPPL	2026-03-12
85307	SUPPL	2026-03-09
85357	SUPPL	2026-03-06
72322	ORIG	2022-10-14
72070	ORIG	2022-09-13
72069	ORIG	2022-09-13
72067	ORIG	2022-09-12