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SOTYKTU Drug Patent Profile

When do Sotyktu patents expire, and what generic alternatives are available?

Sotyktu is a drug marketed by Bristol and is included in one NDA. There are three patents protecting this drug.

This drug has sixty-three patent family members in thirty-six countries.

The generic ingredient in SOTYKTU is deucravacitinib. One supplier is listed for this compound. Additional details are available on the deucravacitinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Sotyktu

Sotyktu will be eligible for patent challenges on September 9, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 9, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SOTYKTU

International Patents:	63
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	1
Patent Applications:	21
Drug Prices:	Drug price information for SOTYKTU
What excipients (inactive ingredients) are in SOTYKTU?	SOTYKTU excipients list
DailyMed Link:	SOTYKTU at DailyMed

See drug prices for SOTYKTU

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SOTYKTU

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

214958

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for SOTYKTU

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Dartmouth-Hitchcock Medical Center	Early Phase 1
Bristol-Myers Squibb	Early Phase 1

See all SOTYKTU clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for SOTYKTU

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

L04AF	Janus-associated kinase (JAK) inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for SOTYKTU

SOTYKTU is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting SOTYKTU

FDA Regulatory Exclusivity protecting SOTYKTU

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol	SOTYKTU	deucravacitinib	TABLET;ORAL	214958-001	Sep 9, 2022		RX	Yes	Yes
Bristol	SOTYKTU	deucravacitinib	TABLET;ORAL	214958-001	Sep 9, 2022		RX	Yes	Yes
Bristol	SOTYKTU	deucravacitinib	TABLET;ORAL	214958-001	Sep 9, 2022		RX	Yes	Yes			Y	Y
Bristol	SOTYKTU	deucravacitinib	TABLET;ORAL	214958-001	Sep 9, 2022		RX	Yes	Yes			Y	Y

EU/EMA Drug Approvals for SOTYKTU

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Bristol-Myers Squibb Pharma EEIG	Sotyktu	deucravacitinib	EMEA/H/C/005755 Treatment of moderate-to-severe plaque psoriasis in adults.	Authorised	no	no	no	2023-03-24

International Patents for SOTYKTU

See the table below for patents covering SOTYKTU around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	E041750
Malaysia	194668	AMIDE-SUBSTITUTED HETEROCYCLIC COMPOUNDS USEFUL AS MODULATORS OF IL-12, IL-23 AND/OR IFN() RESPONSES
Japan	2016506369	ＩＬ−１２、ＩＬ−２３および／またはＩＦＮα応答のモジュレーターとして有用なアミド置換ヘテロ環式化合物
Spain	2914793
Portugal	3495358
Slovenia	3495358
Japan	6585231

Supplementary Protection Certificates for SOTYKTU

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2922846	CR 2023 00024	Denmark		PRODUCT NAME: DEUCRAVACITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1718 20230327
2922846	2023C/531	Belgium		PRODUCT NAME: DEUCRAVACITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1718 20230327
2922846	301238	Netherlands		PRODUCT NAME: DEUCRAVACITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/23/1718 20230327
2922846	PA2023523	Lithuania		PRODUCT NAME: DEUKRAVACITINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1718 20230324
2922846	27/2023	Austria		PRODUCT NAME: DEUCRAVACITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1718 (MITTEILUNG) 20230327
2922846	122023000049	Germany		PRODUCT NAME: DEUCRAVACITINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1718 20230324
2922846	LUC00313	Luxembourg		PRODUCT NAME: DEUCRAVACITINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1718 20230327