STELARA Drug Profile

Summary for Tradename: STELARA

High Confidence Patents:	95
Applicants:	1
BLAs:	2
Drug Prices:	Drug price information for STELARA
Recent Clinical Trials:	See clinical trials for STELARA

See drug prices for STELARA

Recent Clinical Trials for STELARA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Biocon Biologics UK Ltd	PHASE1
Teva takeda	Phase 4
RANI Therapeutics	Phase 1

See all STELARA clinical trials

Pharmacology for STELARA

Mechanism of Action	Interleukin-12 Antagonists Interleukin-23 Antagonists
Established Pharmacologic Class	Interleukin-12 Antagonist Interleukin-23 Antagonist

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for STELARA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for STELARA Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,065,007	2031-03-18	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,099,039	2036-11-17	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,155,018	2037-07-06	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,232,014	2037-06-05	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,266,597	2037-07-24	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for STELARA Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,016,338	2036-12-20	Patent claims search
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,105,354	2037-12-20	Patent claims search
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,111,968	2036-08-10	Patent claims search
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,172,841	2037-12-20	Patent claims search
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261	10,184,001	2036-06-02	Patent claims search

International Patents for STELARA

Country	Patent Number	Estimated Expiration
Australia	2017325010
South Korea	20220054909
World Intellectual Property Organization (WIPO)	2016054107
European Patent Office	4615488
Denmark	2563385

Supplementary Protection Certificates for STELARA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
329 12-2018	Slovakia		PRODUCT NAME: GUSELKUMAB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1234 20171114
16/2018	Austria		PRODUCT NAME: GUSELKUMAB; REGISTRATION NO/DATE: EU/1/17/1234 (MITTEILUNG) 20171114
CA 2018 00016	Denmark		PRODUCT NAME: ET ANTISTOF OMFATTENDE EN AMINOSYRESEKVENS FOR LET KAEDES KOMPLEMENTARITETSBESTEMMENDE REGION 1 (CDRL1) MED SEQ ID NO:50; EN CDRL2-AMINOSYRESEKVENS MED SEQ ID NO:56 OG CDRL3-AMINOSYRESEKVENS MED SEQ ID NO:73; OG...; REG. NO/DATE: EU/1/17/1234 20171114
2018/018	Ireland		PRODUCT NAME: GUSELKUMAB; REGISTRATION NO/DATE: EU/1/17/1234 20171114
1890021-7	Sweden		PRODUCT NAME: GUSELKUMAB; REG. NO/DATE: EU/1/17/1234 20171114

Market Dynamics and Financial Trajectory for STELARA (Ustekinumab)

Last updated: March 17, 2026

What are the key market drivers for STELARA?

STELARA, a monoclonal antibody targeting interleukin-12 and interleukin-23, remains a dominant biologic in treating moderate to severe plaque psoriasis, Crohn’s disease, and ulcerative colitis. Key market drivers include:

• Increasing prevalence: Crohn’s disease affects approximately 400,000–600,000 Americans, with similar numbers in ulcerative colitis. Psoriasis impacts 2–3% of the global population.
• Expanding indications: Approval for psoriatic arthritis in 2018 expanded usage.
• Patient adherence: Once every 8 or 12 weeks dosing increases compliance.
• Competitive landscape: Exacerbated by the entry of biosimilars for other biologics but remains protected by patent exclusivity until 2029 in the U.S.
• Clinical data: Robust efficacy shown in phase III trials, leading to US and EU approvals.

How does STELARA perform commercially?

• Global sales reached $4.2 billion in 2022, a 10% increase over the previous year.
• North America accounts for nearly 50% of sales, driven by high prevalence and strong prescribing habits.
• EU markets contribute approximately 30%, with growth driven by expanding indications and adult/adolescent approvals.
• Rest of the world, including Asia-Pacific and Latin America, makes up about 20%, with growing access.

What are the revenue projections for STELARA?

Year	Estimated Revenue ($ billion)	Key Assumptions
2023	4.4	Continued market penetration; new indication approvals
2024	4.7	Increased adoption in Crohn’s and ulcerative colitis
2025	5.0	Potential market expansion in Asia-Pacific
2026	5.3	Biosimilar competition for other biologics increases

Projections rely on continued demand, pipeline stability, and the absence of major biosimilar disruptions.

How does competitive pressure influence STELARA’s financial outlook?

• Biosimilar entry anticipated around 2029 in the U.S. after patent expiry.
• Biosimilars for adalimumab and infliximab have started affecting market share for those biologics, but STELARA faces less direct competition due to its unique mechanism.
• Ongoing development of JAK inhibitors and oral agents represent alternative treatment options, impacting future growth.

What legal and regulatory factors affect STELARA’s market?

• Patent protections until 2029 in the U.S.
• FDA accelerated approval pathways enabled in Crohn’s disease and ulcerative colitis.
• Pricing regulations, especially in Europe, could pressure margins.
• Ongoing patent litigations in multiple jurisdictions could influence market exclusivity.

Summary of financial trajectory considerations

• Revenue growth driven by expanding indications and geographic markets.
• Margins potentially affected by biosimilar competition post-2029.
• R&D investments and pipeline candidates impact long-term valuation.
• Market size and competition from emerging oral therapies shape future outlook.

Key Takeaways

• STELARA maintains a strong revenue base within biologic treatments for autoimmune diseases.
• Sales growth hinges on market expansion, new indications, and robust clinical data.
• Biosimilar competition is a key risk factor post-2029.
• Regulatory and patent strategies influence market exclusivity timelines.
• Future revenue prospects depend on pipeline success and market dynamics in emerging regions.

FAQs

1. When will biosimilars for STELARA likely enter the market?

   • Biosimilars are scheduled for approval around 2029, following patent expiry.

2. What are the main indications approved for STELARA?

   • Moderate to severe plaque psoriasis, Crohn’s disease, ulcerative colitis, and psoriatic arthritis.

3. How does STELARA compare in price to other biologics?

   • It typically costs between $30,000 and $50,000 annually per patient, similar to other monoclonal antibodies.

4. Are there ongoing pipeline developments for STELARA?

   • No significant pipeline expansions announced; focus remains on existing indications and expanding geographic access.

5. How are regulatory changes impacting STELARA’s market?

   • Clearances for new indications and accelerated approvals support growth; price controls in some regions may affect margins.

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References

[1] Company financial reports and press releases, 2022–2023.
[2] FDA and EMA approval documentation.
[3] Market research reports from IQVIA and EvaluatePharma, 2022.
[4] Public health data from CDC and WHO, 2022.