Home Applications 214958 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 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 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 Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214958-001 SOTYKTU 6MG TABLET / ORAL RLD, RS 2022-09-09 caaa826d4ba7…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 · 94 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 N214958-001 10000480 2033-11-07 Drug substance, Drug product 2022-10-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214958-001 11021475 2033-11-07 U-3434 2022-10-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214958-001 RE47929 2033-11-07 U-4452 Drug substance, Drug product 2022-10-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214958-001 RE47929 2033-11-07 U-3434 Drug substance, Drug product 2022-10-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214958-001 12521390 2043-02-11 U-3434 Drug product 2026-02-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214958-001 12521390 2043-02-11 U-4451 Drug product 2026-02-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214958-001 10000480 2033-11-07 Drug substance, Drug product 2022-10-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214958-001 11021475 2033-11-07 U-3434 2022-10-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214958-001 RE47929 2033-11-07 U-4452 Drug substance, Drug product 2022-10-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214958-001 RE47929 2033-11-07 U-3434 Drug substance, Drug product 2022-10-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214958-001 12521390 2043-02-11 U-3434 Drug product 2026-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214958-001 12521390 2043-02-11 U-4451 Drug product 2026-02-09 caaa826d4ba7…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…
Observed Orange Book exclusivity history# 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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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