Ustekinumab - Biologic Drug Details

Summary for ustekinumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	3
BLAs:	5
Suppliers: see list	4
Recent Clinical Trials:	See clinical trials for ustekinumab

Recent Clinical Trials for ustekinumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
M.D. Anderson Cancer Center	PHASE2
Janssen Research & Development, LLC	PHASE2
Second Affiliated Hospital of Wenzhou Medical University	PHASE3

See all ustekinumab clinical trials

Pharmacology for ustekinumab

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 brand-side disclosures

These patents were identified from searching 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 ustekinumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ustekinumab 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		2031-03-18	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261		2036-11-17	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261		2037-07-06	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261		2037-06-05	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261		2037-07-24	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261		2038-06-29	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261		2035-04-30	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for ustekinumab 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		2036-12-20	Patent claims search
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261		2037-12-20	Patent claims search
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261		2036-08-10	Patent claims search
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261		2037-12-20	Patent claims search
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261		2036-06-02	Patent claims search
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261		2034-01-03	Patent claims search
Janssen Biotech, Inc.	STELARA	ustekinumab	Injection	125261		2037-02-13	Patent claims search

International Patents for ustekinumab

Country	Patent Number	Estimated Expiration
Australia	2019257454
Nicaragua	200800193
Portugal	3736291
South Korea	102677203
European Patent Office	3981403
Australia	2020201347
Canada	3111203

Supplementary Protection Certificates for ustekinumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C 2018 017	Romania		PRODUCT NAME: GUSELKUMAB; NATIONAL AUTHORISATION NUMBER: EU/1/17/1234; DATE OF NATIONAL AUTHORISATION: 20171110; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1234; DATE OF FIRST AUTHORISATION IN EEA: 20171110
SPC/GB18/017	United Kingdom		PRODUCT NAME: GUSELKUMAB; REGISTERED: UK EU/1/17/1234 (NI) 20171114; UK PLGB 00242/0665 20171114
PA2018010,C1971366	Lithuania		PRODUCT NAME: GUSELKUMABAS; REGISTRATION NO/DATE: EU/1/17/1234 20171110
PA2018010	Lithuania		PRODUCT NAME: ANTIKUNAS, APIMANTIS CDRL1 SEKA NR. 50; CDRL2 SEKA NR. 56; IR CDRL3 SEKA NR. 73; IR CDRH1 SEKA NR.5; CDRH2 SEKA NR. 20; CDRH3 SEKA NR. 44; ANTIKUNAS, AB APIMANTIS L GRANDINES VD SEKA NR. 116 IR H GRANDINES VD SEKA NR. 106, YPAC GUSELKUMABAS; REGISTRATION NO/DATE: EU/1/17/1234 20171114
122018000047	Germany		PRODUCT NAME: ANTIKOERPER, DER EINE AMINOSAEURESEQUENZ DER KOMPLEMENTARITAET- BESTIMMENDEN REGION 1 DER LEICHTEN KETTE (CDRL1) GEMAESS SEQ ID NO:50; EINE AMINOSAEURESEQUENZ DER CDRL2 GEMAESS SEQ ID NO:56; UND EINE AMINOSAEURESEQUENZ DER CDRL3 GEMAESS SEQ ID NO:73; UND EINE AMINOSAEURESEQUENZ DER KOMPLEMENTARITAET-BESTIMMENDEN REGION 1 DER SCHWEREN KETTE (CDRH1) GEMAESS SEQ ID NO:5; EINE AMINOSAEURESEQUENZ DER CDRH2 GEMAESS SEQ I; REGISTRATION NO/DATE: EU/1/17/1234 20171110
C01971366/01	Switzerland		PRODUCT NAME: GUSELKUMAB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66583 13.06.2018
18C1018	France		PRODUCT NAME: GUSELKUMAB; REGISTRATION NO/DATE: EU/1/17/1234 20171114

Market Dynamics and Financial Trajectory for the Biologic Drug Ustekinumab

Last updated: August 24, 2025

Introduction

Ustekinumab, marketed as Stelara, is a monoclonal antibody developed by Johnson & Johnson, primarily approved for treating immune-mediated inflammatory conditions including psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. As a biologic targeting interleukins 12 and 23, its innovative mechanism has positioned it prominently within the biopharmaceutical landscape. This analysis explores the market forces influencing ustekinumab’s trajectory, financial performance, and future prospects amid evolving industry and regulatory environments.

Market Position and Growth Drivers

1. Therapeutic Indications and Patient Demographics

Ustekinumab’s broad label for conditions like moderate-to-severe plaque psoriasis and Crohn’s disease has sustained its demand. The chronic nature of these diseases correlates with high treatment adherence and recurring revenue streams. Globally, psoriasis affects approximately 2-3% of the population, translating into a substantial underserved market, particularly in mature economies. The rising prevalence of inflammatory bowel diseases further enhances the drug’s market scope.

2. Competitive Landscape

Ustekinumab faces competition from other biologics, including adalimumab (Humira), secukinumab (Cosentyx), and risankizumab. While adalimumab remains dominant due to early market entry and widespread use, ustekinumab’s unique interleukin targeting affords it differentiation. The introduction of biosimilars (though less imminent for ustekinumab due to patent protections) and newer agents influences the competitive dynamics, incentivizing continuous innovation and strategic positioning.

3. Regulatory and Approval Landscape

Regulatory approvals across North America, Europe, and emerging markets shape market expansion. Johnson & Johnson’s strategic pursuit of label expansions and complementary indications, like Crohn's disease, bolsters future growth pathways. Recent approvals for pediatric use and additional indications solidify its therapeutic positioning.

Market Dynamics and Challenges

1. Patent Expiry and Biosimilar Competition

Ustekinumab’s patents are slated to expire in key markets over the coming decade, raising concerns over biosimilar entry and subsequent pricing pressures. Biosimilars in late development stages threaten to erode market share, necessitating strategies like lifecycle management, line extensions, or formulation innovations to sustain profitability.

2. Pricing and Reimbursement Pressures

Pricing strategies for biologics face intense scrutiny amid healthcare budget constraints. High treatment costs are focal points for payers, particularly in cost-conscious markets such as Europe and North America. Price negotiations, formulary placements, and innovative payment models (e.g., outcome-based agreements) will influence revenue trajectories.

3. Manufacturing and Supply Chain Considerations

Biologics require complex manufacturing processes, with supply chain stability vital to meeting demand and maintaining quality. Disruptions—whether due to geopolitical issues, regulatory shifts, or raw material shortages—could impact product availability and financial outcomes.

4. Research and Development (R&D) and Pipeline Outlook

Continuous innovation through R&D underpins long-term growth. Johnson & Johnson invests heavily in expanding ustekinumab’s indications and developing next-generation interleukin inhibitors. Success in expanding the therapeutic index or improving administration routes (e.g., subcutaneous delivery) will affect market positioning and revenue streams.

Financial Trajectory Analysis

1. Historical Performance

Ustekinumab demonstrated robust financial performance, marked by strong sales growth since its launch in 2009. In 2022, its revenues exceeded $6 billion globally, representing steady double-digit growth (around 10-15%) driven by expanding indications and geographical penetration [1].

2. Revenue Forecasts

Analysts project continued growth for ustekinumab, expected to reach approximately $8-10 billion by 2028, assuming successful indication expansion and market penetration in emerging economies. The compound annual growth rate (CAGR) potentially ranges from 8-12%, contingent on biosimilar market entry and pricing strategies.

3. Impact of Biosimilars and Competition

The imminent patent expiries in key regions (e.g., Europe in the late 2020s) may foster biosimilar competition, possibly reducing revenues by 20-30% unless offset by new indications and market share retention strategies. Johnson & Johnson’s lifecycle management efforts aim to mitigate such impacts through product differentiation and innovative formulations.

4. Profitability and Cost Management

Biologics' high development and manufacturing costs are balanced by high-margin revenues due to lack of direct competition and premium pricing. Operating margins for ustekinumab have historically exceeded 30%, with scalability allowing cost efficiencies over time. Maintaining profitability hinges on managing manufacturing costs and payer negotiations.

Future Outlook and Strategic Considerations

1. Indication Expansion and Market Penetration

Growing approval portfolio, including pediatric Crohn’s disease, allows for increased patient coverage. Efforts to penetrate emerging markets through collaborations and pricing adaptations can significantly elevate revenue prospects.

2. Innovation and Line Extensions

Developing next-generation interleukin inhibitors or combination therapies could sustain long-term growth. Enhancements in delivery mechanisms (e.g., self-injectable formulations) and biosimilar development might accelerate market share expansion.

3. Regulatory and Policy Environment

Anticipated stricter regulatory standards and changes in healthcare reimbursement policies may influence profitability. Applying adaptive strategies, such as outcome-based reimbursement and value-based care models, will be crucial.

4. Strategic Collaborations and Licensing

Forming alliances for indication expansion, manufacturing, or distribution can mitigate risks and facilitate access to new markets. Strategic investments in R&D pipeline molecules will be pivotal given competitive pressures.

Key Takeaways

• Ustekinumab holds a strong position within the biologic market for immune-mediated inflammatory diseases, driven by its differentiated mechanism and expanding indications.
• Patent expiries and biosimilar entries pose significant threats; thus, lifecycle management and innovation are key to sustaining revenue.
• Revenue is projected to grow steadily, with forecasts reaching $8-10 billion by 2028, though future growth depends on competitive dynamics and pricing strategies.
• Market expansion into emerging economies and continued indication approvals offer substantial growth opportunities.
• Managing manufacturing costs, forging strategic collaborations, and navigating regulatory landscapes are critical for optimizing financial outcomes.

Conclusion

Ustekinumab’s evolution reflects the broader dynamics shaping the biologic therapeutics market—marked by innovation, competitive pressures, and regulatory complexity. Its financial trajectory remains promising, underpinned by clinical efficacy and expanding indications, but hinges on strategic lifecycle management amid patent expiries and biosimilar competition. Stakeholders must adopt adaptive approaches to leverage opportunities and mitigate risks for sustainable growth.

---

FAQs

1. When is Ustekinumab expected to face biosimilar competition in major markets?
Patent protections for ustekinumab are expected to lapse in Europe around 2026-2028, with similar timelines in other regions. Biosimilar development is underway, and entry will likely influence pricing and market share.

2. What are the primary drivers for Ustekinumab’s revenue growth?
Key drivers include expanding indications (e.g., Crohn’s disease, pediatric uses), geographic expansion into emerging markets, and increasing prevalence of target conditions.

3. How does Ustekinumab compare with competitors like adalimumab?
While adalimumab benefits from earlier market entry and broader indications, ustekinumab distinguishes itself through its interleukin targeting, often resulting in favorable efficacy profiles and safety, influencing its market niche.

4. What future innovations could impact Ustekinumab’s market position?
Potential innovations include next-generation interleukin inhibitors, improved delivery formulations, and combination therapies, which could enhance efficacy and patient adherence.

5. How are healthcare payers influencing Ustekinumab’s market prospects?
Payers are increasingly emphasizing value-based and outcome-based reimbursement models, exerting pressure on pricing. Successful navigation of these policies is crucial for market access and growth.