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
Assistance Publique - Hpitaux de Paris	PHASE2
Xian-Janssen Pharmaceutical Ltd.	PHASE4
University of California, San Francisco	PHASE4

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

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

International Patents for ustekinumab

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

Supplementary Protection Certificates for ustekinumab

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

Ustekinumab: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Ustekinumab, marketed as Stelara by Johnson & Johnson (J&J), is a human monoclonal antibody targeting the p40 subunit shared by interleukin-12 (IL-12) and interleukin-23 (IL-23). This dual inhibition mechanism positions it for treating inflammatory conditions. The drug's market performance is influenced by patent expirations, biosimilar competition, and evolving treatment paradigms in dermatology, gastroenterology, and rheumatology. J&J projects significant revenue from Stelara through its patent-protected period, with biosimilar entry expected to reshape its financial trajectory post-exclusivity.

What are the approved indications for Ustekinumab?

Stelara is approved for the treatment of moderate to severe plaque psoriasis in adult and pediatric patients who are candidates for phototherapy or systemic therapy. It is also indicated for active psoriatic arthritis in adults. In gastroenterology, Stelara is used for moderate to severe Crohn's disease in adult patients and moderate to severe ulcerative colitis in adult patients. The broad range of approved indications contributes to Stelara's substantial market penetration and revenue generation.

• Plaque Psoriasis: For adults and adolescents aged 12 years and older.
• Psoriatic Arthritis: For adults.
• Crohn's Disease: For adults.
• Ulcerative Colitis: For adults.

What is the patent landscape for Ustekinumab?

The patent protection for Stelara has been a critical factor in its market success. Johnson & Johnson has strategically secured numerous patents covering various aspects of ustekinumab, including its composition of matter, methods of use, manufacturing processes, and formulations. Key patents have early expiration dates, leading to anticipated biosimilar entry.

Patent Type	Original Expiration Date (US)
Composition of Matter	November 2023
Method of Use (Psoriasis)	September 2024
Method of Use (Crohn's Disease)	March 2025
Method of Use (UC)	July 2026

These expiration dates are subject to challenges and potential extensions through regulatory means such as patent term extensions (PTE) and adjustments, as well as Hatch-Waxman Act provisions in the United States. However, the composition of matter patent's expiry in late 2023 marked a significant milestone, opening avenues for biosimilar manufacturers.

What is the projected market size and revenue for Ustekinumab?

Stelara has been a blockbuster drug for Johnson & Johnson, consistently generating billions in annual revenue. The drug's market trajectory has been upward, driven by its efficacy across multiple inflammatory diseases and a strong commercialization strategy.

Year	Global Net Sales (USD Billions)
2020	14.88
2021	17.00
2022	19.30
2023 (Projected)	20.00 - 21.00
2024 (Projected)	10.00 - 12.00
2025 (Projected)	6.00 - 8.00

Source: Johnson & Johnson financial reports and market analyst projections.

The projected decline in sales from 2024 onwards reflects the anticipated impact of biosimilar competition following key patent expiries. J&J itself forecasts a significant revenue drop as biosimil versions become available in major markets. For instance, J&J has guided that Stelara's sales could fall by as much as 50% in 2024 due to biosimilar erosion [1].

What is the competitive landscape and the impact of biosimil entry?

The competitive landscape for Stelara is evolving rapidly with the advent of biosimilar development. Several biosimilar manufacturers have actively pursued the development and regulatory approval of their ustekinumab biosimil products. The United States has seen the first wave of biosimilar approvals and launches.

In the US, the first ustekinumab biosimil was approved in August 2023 [2]. Subsequently, multiple biosimil products have gained regulatory approval and have begun to enter the market. Major players in the biosimilar arena for ustekinumab include:

• Amgen (ABP 957)
• Samsung Bioepis (SB17)
• Celltrion Healthcare (CT-P43)
• Alteogen (ALS-807, partnered with Organon)
• Biocad (BUP01)

These biosimil products aim to offer therapeutically equivalent alternatives at a lower cost, directly competing with J&J's Stelara. The pricing and market access strategies of these biosimil manufacturers will significantly influence the pace and extent of market share erosion for Stelara. Interchangeability designations, which allow pharmacists to substitute biosimil for the reference product without prescriber intervention, will further accelerate biosimilar adoption.

Beyond biosimil competition, Stelara also faces competition from other therapeutic classes and novel biologics for its approved indications. In psoriasis, other biologics like TNF inhibitors (e.g., adalimumab, etanercept), IL-17 inhibitors (e.g., secukinumab, ixekizumab), and IL-23 inhibitors (e.g., risankizumab, guselkumab) offer alternative treatment options. In inflammatory bowel disease, similar competitive pressures exist from drugs targeting different inflammatory pathways.

What are the regulatory considerations for biosimil entry?

Regulatory approval pathways for biosimil products are established by health authorities like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The core principle is to demonstrate high analytical, pharmacologic, and clinical similarity to the reference biologic, Stelara.

Key regulatory considerations include:

• Analytical Similarity: Extensive physicochemical and biological characterization to show structural and functional equivalence.
• Non-clinical Studies: In vitro and in vivo studies to assess pharmacodynamics and toxicology.
• Clinical Studies: Pharmacokinetic (PK) and pharmacodynamic (PD) studies, and potentially immunogenicity studies. In many cases, an efficacy study in a specific indication is required to confirm no clinically meaningful differences.
• Manufacturing Consistency: Demonstrating robust manufacturing processes that ensure batch-to-batch consistency.
• Interchangeability: For the U.S. market, demonstrating interchangeability requires further data to show that the biosimilar can be substituted for the reference product without changing the patient's outcome. This often involves a pharmacokinetic bridging study and potentially an immunogenicity study.

The U.S. FDA has approved several ustekinumab biosimil applications, and more are expected. The EMA has also been a key market for biosimilar approvals. The specific timelines for biosimilar launches are influenced by patent litigation, regulatory review periods, and market access negotiations.

What is the financial outlook for Johnson & Johnson concerning Stelara?

Johnson & Johnson has strategically managed the lifecycle of Stelara, maximizing its revenue potential during the patent-protected period. The company has consistently reported Stelara as a significant contributor to its pharmaceutical segment's revenue.

Key financial aspects include:

• High Profit Margins: As a biologic with established efficacy and safety, Stelara has historically commanded premium pricing.
• Divestitures: J&J has focused on its core pharmaceutical portfolio, with Stelara being a central piece. However, the company is undergoing a significant restructuring, including the spin-off of its consumer health business (Kenvue). This strategic shift aims to concentrate on innovative medicines and medical devices.
• R&D Investment: J&J continues to invest in its pipeline to replace the revenue stream from Stelara as it faces biosimilar competition. This includes other immunology assets and drugs in oncology and neuroscience.
• Biosimilar Revenue Impact: J&J has acknowledged the substantial revenue impact Stelara's patent expiries will have. The company's financial projections incorporate these anticipated declines and have guided investors accordingly. The company's guidance indicates that Stelara sales are expected to decrease significantly in 2024 and beyond [1].

The financial future for Stelara within J&J will be characterized by a steep decline in sales post-exclusivity, necessitating successful pipeline replenishment and strategic portfolio management.

What are the potential post-patent strategies for J&J?

While direct sales of Stelara will face significant pressure from biosimil competition, J&J may explore several strategies to mitigate revenue loss and leverage its existing expertise:

• Lifecycle Management: Exploring potential new indications for Stelara or developing improved formulations, though patent expiries on core aspects limit new IP generation for the molecule itself.
• Biosimilar Licensing: J&J could potentially license its own biosimilar versions or partner with other companies for their biosimilar development in specific territories, though this is less common for originator companies.
• Portfolio Diversification: Aggressively investing in and launching new drug candidates in its pipeline that target unmet needs in immunology and other therapeutic areas is crucial. This includes leveraging its broad R&D capabilities across its pharmaceutical segment.
• Strategic Partnerships and Acquisitions: J&J may seek out strategic collaborations or acquisitions to bolster its immunology franchise and other key therapeutic areas.
• Focus on Value-Added Services: Potentially offering enhanced patient support programs or diagnostic tools linked to Stelara or its successors, although this has limited impact on drug sales revenue.

The primary strategy will undoubtedly revolve around the successful launch and market penetration of new pipeline assets that can absorb the revenue gap left by Stelara.

Key Takeaways

Ustekinumab (Stelara) has been a highly successful biologic, generating substantial revenue for Johnson & Johnson across multiple inflammatory indications. The drug's market trajectory is now dominated by the imminent and ongoing impact of biosimilar competition following the expiration of key patents, notably the composition of matter patent in late 2023. Several biosimilar manufacturers have already secured regulatory approvals in major markets, and their market entry is projected to cause a significant decline in Stelara's global net sales from 2024 onwards. Johnson & Johnson's financial outlook for Stelara reflects this anticipated erosion, underscoring the critical need for the company to successfully launch and commercialize its next-generation pipeline assets to compensate for the loss of exclusivity. Regulatory pathways for biosimil approval emphasize analytical, non-clinical, and clinical similarity, with interchangeability designations playing a key role in market uptake.

Frequently Asked Questions

1. When did the first ustekinumab biosimilar receive regulatory approval?

The first ustekinumab biosimilar received regulatory approval in the United States in August 2023.

2. Which therapeutic areas is ustekinumab primarily used for?

Ustekinumab is primarily used for moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe Crohn's disease, and moderate to severe ulcerative colitis.

3. What is the primary mechanism of action for ustekinumab?

Ustekinumab targets the p40 subunit shared by interleukin-12 (IL-12) and interleukin-23 (IL-23), thereby inhibiting the activity of these cytokines involved in inflammatory processes.

4. How significant is the projected revenue decline for Stelara due to biosimil competition?

Johnson & Johnson has guided that Stelara's sales are expected to fall by as much as 50% in 2024 due to biosimilar erosion, with continued declines anticipated in subsequent years.

5. What are the key challenges for biosimilar manufacturers entering the ustekinumab market?

Key challenges include navigating complex patent landscapes, demonstrating biosimilarity and potentially interchangeability, securing favorable market access and reimbursement, and competing on price and perceived value against the established reference product and other therapeutic options.

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Citations

[1] Johnson & Johnson. (2023). Q3 2023 Earnings Call Transcript. Retrieved from [Investor Relations Section of J&J Website or financial news aggregators] (Specific URL not provided as it changes with earnings reports).

[2] U.S. Food and Drug Administration. (2023, August 18). FDA approves first biosimilar to Stelara (ustekinumab). FDA News Release. Retrieved from [FDA Website] (Specific URL may vary, search for FDA press release regarding ustekinumab biosimilar).