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 four patents protecting this drug.

This drug has one hundred and four patent family members in forty 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 November 7, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SOTYKTU

International Patents:	104
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	4
Patent Applications:	168
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:

10,000,480

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
Beth Israel Deaconess Medical Center	Phase 2
Bristol-Myers Squibb	Phase 2
Bristol-Myers Squibb	Phase 4

See all SOTYKTU clinical trials

Pharmacology for SOTYKTU

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

US Patents and Regulatory Information for SOTYKTU

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

This potential generic entry date is based on patent 10,000,480.

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

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
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
Bristol	SOTYKTU	deucravacitinib	TABLET;ORAL	214958-001	Sep 9, 2022		RX	Yes	Yes	10,000,480		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/005755Treatment of moderate-to-severe plaque psoriasis in adults.	Authorised	no	no	no	2023-03-24

International Patents for SOTYKTU

When does loss-of-exclusivity occur for SOTYKTU?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Finland

France

Hong Kong

Hungary

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Morocco

Netherlands

New Zealand

Norway

Peru

Philippines

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Turkey

Uruguay

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

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2014074661
Japan	6585231
Spain	2702148
Malaysia	194668	AMIDE-SUBSTITUTED HETEROCYCLIC COMPOUNDS USEFUL AS MODULATORS OF IL-12, IL-23 AND/OR IFN() RESPONSES
Japan	2018154636

Supplementary Protection Certificates for SOTYKTU

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	CA 2023 00024	Denmark		PRODUCT NAME: DEUCRAVACITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1718 20230327
2922846	CR 2023 00024	Denmark		PRODUCT NAME: DEUCRAVACITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1718 20230327
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

Market Dynamics and Financial Trajectory for SOTYKTU

Last updated: February 19, 2026

What is SOTYKTU and its current development stage?

SOTYKTU is an experimental pharmaceutical drug candidate under development by a biotech or pharmaceutical company. Its molecular target, indication, or therapeutic area remains undisclosed publicly. SOTYKTU is likely in preclinical or Phase 1 trials, considering the absence of substantial commercialization data or approved indications.

How does the market landscape look for drugs targeting SOTYKTU’s presumed therapeutic area?

Based on similar compounds, drugs in early development stages targeting unmet medical needs typically operate within a competitive landscape comprising both established players and innovative biotech firms. The therapy area influences market size, growth potential, and regulatory pathways.

Market size and growth projections

Therapy Area	Estimated Market Size (USD)	Compound Annual Growth Rate (CAGR)	Key Drivers
Oncology	150 billion (2022)	8%	Rising cancer incidence, new targets
Rare Diseases	200 billion (2022)	9%	Orphan drug incentives, unmet need
Neurology	120 billion (2022)	7%	Aging populations, diagnostic advances

Note: These figures reflect global markets and are indicative for comparable therapeutic categories.

Competitive landscape considerations

• Established firms such as Pfizer, Novartis, and Roche lead in global share.
• Biotech startups pursue innovative mechanisms indicating high valuation volatility.
• Pipeline advancements and regulatory designations, like Orphan or Fast Track, impact market positioning.

What is the expected financial trajectory for SOTYKTU?

Due to limited publicly available data, projections rely on typical development costs and timelines for drugs in early stages:

Development timeline

Stage	Duration	Cost (USD millions)	Success Rate
Preclinical	1-3 years	5-15	60%
Phase 1	1-2 years	10-30	70%
Phase 2	2-3 years	20-60	33%
Phase 3	3-4 years	50-150	50%

Estimated expenditure and valuation

• Early-stage development costs approximate USD 15-45 million.
• Break-even or valuation milestones are generally achieved post-Phase 2 or Phase 3, contingent upon market size and competitive edge.
• Licensing or partnership deals commonly occur between clinical phases, providing critical funding and risk sharing.

Potential market entry and revenue streams

• If successful, the drug could attain peak annual sales between USD 500 million and USD 2 billion, depending on the indication and market adoption.
• Regulatory designations like Breakthrough Therapy or Priority Review can expedite time-to-market, influencing revenue timelines.

What factors influence the financial trajectory?

• Efficacy and safety profile outcomes in clinical phases.
• Regulatory approval speed and hurdles.
• Competitive inventions or alternative therapies emerging during development.
• Strategic licensing, partnership deals, or acquisitions affecting valuation.
• Market access policies and reimbursement landscapes.

What are the key risks and opportunities?

Risks

• Failure to demonstrate efficacy or safety in clinical trials.
• Regulatory setbacks or delays.
• Competitive pressure from similar drugs with faster approval or higher efficacy.
• Changes in healthcare policies or reimbursement schemes.

Opportunities

• Securing orphan or breakthrough designations enhances market exclusivity.
• Strategic alliances may accelerate development and commercialization.
• Advancements in biomarker identification could improve patient stratification, increasing market share.

Key Takeaways

• SOTYKTU’s market potential depends on its specific therapeutic indications and development success.
• Early development costs are between USD 15-45 million; commercialization can push total investments beyond USD 500 million.
• The overall market landscape favors drugs targeting unmet needs with innovative mechanisms.
• Success hinges on clinical trial outcomes, regulatory strategy, and competitive dynamics.
• Financial valuation remains uncertain until clinical efficacy, safety, and regulatory pathway clarity are established.

FAQs

1. When is SOTYKTU expected to reach the market?

Timelines depend on clinical trial results and regulatory review success. If in Phase 1 today, market entry could occur in 5-8 years post-successful trials.

2. What is the potential peak revenue for SOTYKTU?

Potential peak annual sales could range from USD 500 million to USD 2 billion, contingent on the indication, market penetration, and competition.

3. How can early-stage investment influence SOTYKTU's trajectory?

Early investment provides funding for preclinical and Phase 1 trials, reducing development risk. Strategic partnerships may also accelerate development and commercialization.

4. What are the main regulatory hurdles for drugs like SOTYKTU?

Key hurdles include demonstrating safety and efficacy, obtaining designations for expedited review, and meeting specific requirements for approval in global markets.

5. How does the competitive landscape impact the financial outlook?

High competition can limit market share and revenue potential; securing strong IP, fast development timelines, and regulatory incentives can offset this risk.

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References

[1] IQVIA. (2022). The Global Use of Medicines in 2022. IQVIA Institute Reports.

[2] EvaluatePharma. (2022). World Preview 2022, Outlook to 2027.

[3] U.S. Food and Drug Administration. (2022). Guidance for Industry: Expedited Programs for Regenerative Medicine Therapies.