Viewing data from:

SOTYKTU

NDA

DEUCRAVACITINIB | N214958 | BRISTOL MYERS SQUIBB CO

1 strength4 unique patents2 unique exclusivities

Patent Timeline

4 unique patents, 2 exclusivities by expiration date

Active (4)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

2043

Today

Nov. 7, 2033

Nov. 7, 2033

Nov. 7, 2033

Feb. 11, 2043

NCE

Sep. 9, 2027

I-986

Mar. 6, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

3 trials from ClinicalTrials.gov — 1 recruiting, 2 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis NCT06143878	Phase 3	Active	Janssen Research & Development, LLC	774	2024-02-01 → 2027-06-01
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)NCT06220604	Phase 3	Active	Janssen Research & Development, LLC	731	2024-03-09 → 2027-09-20
A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic Arthritis NCT06869551	Phase 3	Recruiting	Bristol-Myers Squibb	60	2025-03-13 → 2031-03-04

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Sotyktu (2023)

Total Spending

$34.3M

Total Claims

4,669

Beneficiaries

1,148

Avg Cost/Unit

$216.95

Spending Trend

$1.5M(2022)→$34.3M(2023)

YoY Change:+1.1%

5yr CAGR:+1.1%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain10 active DMFs

9 active API suppliers hold Drug Master Files for this ingredient.

CIPLA LTDDEUCRAVACITINIB

DMF 409622025

CHANGZHOU PHARMACEUTICAL FACTORYDEUCRAVACITINIB

DMF 410932025

MOEHS IBERICA SLDEUCRAVACITINIB

DMF 412942025

DR REDDYS LABORATORIES LTDDEUCRAVACITINIB

DMF 414522025

CURIA SPAIN SAUDEUCRAVACITINIB

DMF 416262025

CHIRAL QUEST (SUZHOU) CO LTDDEUCRAVACITINIB INTERMEDIATE-2-METHOXY-3-(1-METHYL-1H-1,2,4-TRIAZOL-3-YL)ANILINE

DMF 416382025

CHIRAL QUEST (SUZHOU) CO LTDDEUCRAVACITINIB INTERMEDIATE-ETHYL 4,6-DIHYDROXYPYRIDAZINE-3-CARBOXYLATE

DMF 419402025

ALIVUS LIFE SCIENCES LTDDEUCRAVACITINIB

DMF 426632025

XUZHOU WANBANG JINQIAO PHARMA CO LTDDEUCRAVACITINIB

DMF 430052025

ZYDUS LIFESCIENCES LTDDEUCRAVACITINIB

DMF 433182025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jun 11, 2026	SUPPL -3	View Letter (PDF)
Mar 9, 2026	SUPPL -2	View Letter (PDF)
Sep 12, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 6MG

RLD

4 patents2 exclusivities▴

TABLET;ORAL | Approved: Sep 9, 2022

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE47929	Nov 7, 2033	—	Yes	Yes	U-4452	—
10000480	Nov 7, 2033	—	Yes	Yes	—	—
11021475	Nov 7, 2033	—	—	—		—
12521390	Feb 11, 2043	—	—	Yes		—

Exclusivities (2)

Code	Date	Status
I-986	Mar 6, 2029	Active
NCE	Sep 9, 2027	Active