Deucravacitinib - Generic Drug Details

What are the generic drug sources for deucravacitinib and what is the scope of patent protection?

Deucravacitinib is the generic ingredient in one branded drug marketed by Bristol and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Deucravacitinib has one hundred and four patent family members in forty countries.

One supplier is listed for this compound.

Summary for deucravacitinib

International Patents:	104
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	44
What excipients (inactive ingredients) are in deucravacitinib?	deucravacitinib excipients list
DailyMed Link:	deucravacitinib at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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 deucravacitinib

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

Sponsor	Phase
University of California, San Francisco	PHASE4
University of Texas Southwestern Medical Center	PHASE4
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	PHASE2

See all deucravacitinib clinical trials

Pharmacology for deucravacitinib

Drug Class	Tyrosine Kinase 2 Inhibitor
Mechanism of Action	Tyrosine Kinase 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for deucravacitinib

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 deucravacitinib

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	12,521,390		Y
Bristol	SOTYKTU	deucravacitinib	TABLET;ORAL	214958-001	Sep 9, 2022		RX	Yes	Yes	10,000,480		Y	Y
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	11,021,475
Bristol	SOTYKTU	deucravacitinib	TABLET;ORAL	214958-001	Sep 9, 2022		RX	Yes	Yes	RE47929		Y	Y

EU/EMA Drug Approvals for deucravacitinib

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

International Patents for deucravacitinib

Country	Patent Number	Title	Estimated Expiration
Japan	6407159
Denmark	2922846
Cyprus	1121188
Malaysia	194668
Croatia	P20260058
South Korea	20150081339
Japan	2018154636	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 (AMIDE-SUBSTITUTED HETEROCYCLIC COMPOUNDS USEFUL AS MODULATORS OF IL-12, IL-23 AND/OR IFNα RESPONSES)

Supplementary Protection Certificates for deucravacitinib

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	301238	Netherlands		PRODUCT NAME: DEUCRAVACITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/23/1718 20230327
2922846	C20230028	Finland		PRODUCT NAME: MAVAKAMTEEN;REG NO/DATE: EU/1/23/1716; 27.06.2023
2922846	2390505-2	Sweden		PRODUCT NAME: DEUCRAVACITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/23/1718, 2023-03-27; RAETTAD SKYDDSTID FOER TILLAEGGSSKYDD; DEN 25-04-28 MEDDELADE PRV BESLUT OM RAETTAT SKYDDSTID FOER FOELJANDE TILLAEGGSSKYDD: 2390505-2
2922846	C202330032	Spain		PRODUCT NAME: DEUCRAVACITINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/23/1718; DATE OF AUTHORISATION: 20230324; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1718; DATE OF FIRST AUTHORISATION IN EEA: 20230324
2922846	LUC00313	Luxembourg		PRODUCT NAME: DEUCRAVACITINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1718 20230327
2922846	23C1030	France		PRODUCT NAME: DEUCRAVACITINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/23/1718 20230327

Market Dynamics and Financial Trajectory for Deucravacitinib

Last updated: February 19, 2026

What is the current market position of deucravacitinib?

Deucravacitinib, a selective TYK2 inhibitor developed by AbbVie, received FDA approval in September 2022 for moderate to severe plaque psoriasis. It is positioned as a first-in-class oral therapy targeting a specific Janus kinase (JAK) pathway, with potential applications extending to other autoimmune diseases such as psoriatic arthritis and systemic lupus erythematosus (SLE). Its unique mechanism provides competitive differentiation from oral JAK inhibitors and biologics.

How does deucravacitinib compare to competing treatments?

Treatment Type	Mechanism	Administration	Approval Status	Indication
Deucravacitinib	Selective TYK2 inhibition	Oral	FDA approved (2022)	Plaque psoriasis, potential others
Brodalumab	IL-17 receptor antagonist	Subcutaneous	Approved globally	Psoriasis
Secukinumab	IL-17A inhibitor	Subcutaneous	Approved globally	Psoriasis, psoriatic arthritis
Tildrakizumab	IL-23 inhibitor	Subcutaneous	Approved globally	Psoriasis

Deucravacitinib's oral route and specificity potentially offer benefits over biologics, which require injections and carry immunogenicity risks. Its differentiated mechanism targets the TYK2 pathway more selectively than broader JAK inhibitors, possibly reducing side effects.

What are the revenue forecasts and financial outlook?

AbbVie's initial sales projection for deucravacitinib in psoriasis aimed at approximately $1 billion annually by 2026. Historically, first-in-class innovations capture market share rapidly, especially for unmet needs like moderate to severe psoriasis.

Early sales data and market penetration

• 2022: Launch volume remains limited; initial quarterly sales estimated at $50 million.
• 2023: Sales accelerate as physician adoption increases; projected quarterly sales of $150 million by Q4.
• 2026: Industry analysts estimate revenue around $1 billion, assuming steady growth and expansion into new indications.

Market share assumptions

• Deucravacitinib could attain 25-30% of the psoriasis oral treatment segment within five years.
• Growth driven by expanding indications (e.g., psoriatic arthritis, SLE), with potential for patent exclusivity until 2032.

Costs and R&D investments

• AbbVie’s R&D spend on deucravacitinib exceeds $500 million since inception.
• Launch costs, including marketing and distribution, estimated at $200 million annually.

What factors influence market dynamics?

Regulatory and clinical developments

• Positive progression through clinical trials for alternative indications boosts revenue potential.
• Ongoing phase 3 trials for systemic lupus erythematosus and psoriatic arthritis expected to complete by 2024-2025.

Competitive landscape

• Brodalumab, secukinumab, and tildrakizumab dominate the biologic segment.
• JAK inhibitors such as tofacitinib and baricitinib face regulatory scrutiny for safety concerns.
• A shift toward targeted, oral immune modulators favors deucravacitinib’s market entry.

Pricing and reimbursement

• List price for deucravacitinib approximates $50,000 annually per patient.
• Negotiations with payers could influence actual reimbursement levels.
• High efficacy with a favorable safety profile enhances payor acceptance.

Intellectual property and patent protection

• Patent portfolio extending beyond 2030 provides competitive barrier.
• Patent litigations or challenges could influence launch and pricing strategies.

What is the long-term outlook?

Deucravacitinib’s market trajectory depends on:

• Expansion into additional autoimmune indications with significant unmet needs.
• Continuous demonstration of safety and efficacy in real-world settings.
• Competitive responses from biologic and other small-molecule therapies.

Analysts project a compound annual growth rate (CAGR) of approximately 20-25% for the global psoriasis market over the next five years, with deucravacitinib capturing an increasing share due to its oral formulation and targeted mechanism.

Key Takeaways

• Deucravacitinib's approval introduces a novel oral TYK2 inhibitor with potential across autoimmune diseases.
• Early sales are promising, with projections reaching $1 billion annually by 2026.
• Competitive advantages stem from its mechanism, administration route, and safety profile.
• Market growth will be influenced by additional approvals, payer policies, and competition.
• Patent protection and pipeline expansion are critical to maintaining market position.

FAQs

1. What are the primary therapeutic advantages of deucravacitinib?

It offers oral administration, selective TYK2 inhibition to reduce off-target effects, and demonstrates promising safety and efficacy profiles in psoriasis.

2. How might competition impact deucravacitinib’s market share?

Biologics dominate the psoriasis treatment landscape; however, the convenience of an oral therapy and specific mechanism may allow deucravacitinib to secure a niche. Safety concerns surrounding broader JAK inhibitors may favor deucravacitinib's positioning.

3. What are the key risks for investors in deucravacitinib?

Potential safety issues emerging in post-marketing surveillance, delays in expanding indications, pricing negotiations, and patent challenges could impact revenue.

4. What are the upcoming clinical milestones?

Phase 3 trials for psoriatic arthritis and systemic lupus erythematosus completion expected by 2024-2025.

5. What is the outlook for pricing and reimbursement?

While list prices are high, payer negotiation could lead to discounts. The drug’s efficacy and safety profile may influence favorable reimbursement decisions.

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Sources

1. Food and Drug Administration. (2022). FDA approves deucravacitinib for psoriasis.
2. AbbVie. (2023). Deucravacitinib product pipeline and commercial strategy.
3. EvaluatePharma. (2023). Global autoimmune treatments market analysis.
4. IQVIA. (2023). Biologics and oral therapies market share report.
5. MarketWatch. (2023). Forecasts for psoriasis treatment market growth.