YERVOY Drug Profile

Summary for Tradename: YERVOY

High Confidence Patents:	9
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for YERVOY

Recent Clinical Trials for YERVOY

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Shanghai Henlius Biotech	PHASE1
Shanghai Henlius Biotech	PHASE3
Sandoz	PHASE3

See all YERVOY clinical trials

Pharmacology for YERVOY

Mechanism of Action	CTLA-4-directed Antibody Interactions
Physiological Effect	Increased T Lymphocyte Activation
Established Pharmacologic Class	CTLA-4-directed Blocking Antibody

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 YERVOY Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for YERVOY 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
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377	10,039,836	2036-08-01	DrugPatentWatch analysis and company disclosures
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377	10,744,228	2036-09-01	DrugPatentWatch analysis and company disclosures
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377	11,464,749	2039-07-31	DrugPatentWatch analysis and company disclosures
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377	6,984,720	2020-08-24	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for YERVOY 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
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377	10,016,365	2036-02-12	Patent claims search
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377	10,016,421	2035-04-06	Patent claims search
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377	10,022,451	2035-05-11	Patent claims search
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377	10,034,938	2033-08-30	Patent claims search

International Patents for YERVOY

Country	Patent Number	Estimated Expiration
South Africa	200201190
Turkey	200200735
Estonia	200100336
European Patent Office	2112166

Supplementary Protection Certificates for YERVOY

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2/2012	Austria		PRODUCT NAME: IPILIMUMAB; REGISTRATION NO/DATE: EU/1/11/698/001-002 20110713
300511	Netherlands		PRODUCT NAME: IPILIMUMAB; REGISTRATION NO/DATE: EU/1/11/698/001 - 002 20110713
2012/001	Ireland		PRODUCT NAME: IPILIMUMAB; REGISTRATION NO/DATE: EU/1/11/698/001-002 20110713
C01212422/01	Switzerland		PRODUCT NAME: IPILIMUMAB; REGISTRATION NO/DATE: SWISSMEDIC 61798 14.10.2011

Market Dynamics and Financial Trajectory for the Biologic Drug: YERVOY

Last updated: September 19, 2025

Introduction

YERVOY (ipilimumab) stands as a pioneering immune checkpoint inhibitor developed by Bristol-Myers Squibb (BMS). It was approved by the U.S. Food and Drug Administration (FDA) in 2011 for the treatment of metastatic melanoma and has subsequently expanded its indication portfolio. As a fully human monoclonal antibody targeting CTLA-4, YERVOY plays a central role in the evolving landscape of immuno-oncology. Its market dynamics and financial trajectory are shaped by multiple factors including clinical efficacy, competitive innovation, regulatory environment, pricing strategies, and emerging combination therapies.

Market Overview and Dynamics

1. Therapeutic Area and Disease Burden

YERVOY primarily targets metastatic melanoma, a historically challenging indication due to limited treatment options. The global burden of melanoma has increased with rising UV exposure, yet therapeutic options have advanced rapidly with immunotherapy. The advent of YERVOY initially transformed the treatment paradigm by providing a durable response through immune activation. Currently, the median survival in advanced melanoma improved substantially with immune checkpoint inhibitors, where YERVOY remains integral, either standalone or in combination with nivolumab (Opdivo).

2. Competitive Landscape and Innovation

The immuno-oncology space is highly competitive, with key competitors including nivolumab (Opdivo, Bristol-Myers Squibb), pembrolizumab (Keytruda, Merck), and newer agents like relatlimab (LAG-3 inhibitor). The introduction of combination regimens, such as YERVOY with nivolumab, has shown enhanced efficacy, expanding its market share despite increased toxicity concerns. The approval of these combinations—e.g., CheckMate 067—significantly boosted sales, reflecting a strategic shift toward combination immunotherapies.

Emerging therapies, including novel checkpoint inhibitors and cell-based approaches, threaten to erode YERVOY’s market share in the long term. Nonetheless, YERVOY’s unique mechanism, especially in combination settings, maintains its relevance.

3. Regulatory Milestones and Expansion

Over the past decade, YERVOY's indications expanded to include adjuvant melanoma (FDA approval in 2015), combination therapy for microsatellite stable (MSS) colorectal cancer, and other solid tumors. These approvals extend its market potential but also complicate manufacturing and supply chains.

In 2022, BMS received FDA approval for YERVOY combined with nivolumab as a frontline treatment for MSI-H or dMMR metastatic colorectal cancer, reinforcing its position in personalized immunotherapy indications. Regulatory pathways continue to evolve, with accelerated approvals and post-market expansions influencing long-term revenue strategies.

4. Pricing, Reimbursement, and Access

YERVOY commands premium pricing, often in the range of several thousand dollars per infusion, justified by its clinical benefit. Reimbursement negotiations, particularly in cost-conscious markets, influence its market penetration. Value-based pricing models and managed care strategies are increasingly critical, especially for combination regimens with higher cumulative costs.

Patient access programs and biosimilar developments pose ongoing threats to pricing power. Although biosimilar competition remains limited due to complex manufacturing and patent protections, future biosimilars may influence market share and pricing dynamics.

Financial Trajectory and Revenue Projections

1. Historical Revenue Performance

Bristol-Myers Squibb reported YERVOY revenues of approximately $1.57 billion in 2022, reflecting strong uptake in melanoma and expanded indications. The upfront success was driven by the immunotherapy revolution and the combination with nivolumab, which accounted for a significant proportion of sales.

Early years saw rapid growth post-approval, with a peak in 2015-2016, followed by stabilization and slight declines as competitors entered the scene. Nevertheless, the introduction of new indications and combination regimens has sustained revenue levels.

2. Future Revenue Drivers

The financial outlook for YERVOY hinges on clinical pipeline success, regulatory approvals, and market penetration in emerging indications. Its role as a backbone in combination therapies enhances its sales potential. For example, in 2023, BMS announced ongoing clinical trials combining YERVOY with novel agents, which could unlock new markets.

The consolidation of indications, particularly in lung, colorectal, and renal cancers, is expected to broaden its revenue base. Additionally, advances in biomarker-driven therapies and precision immuno-oncology may refine patient stratification, increasing the therapy’s efficacy and cost-effectiveness.

3. Risks and Competitive Challenges

Competitive pressures from next-generation immunotherapies and combination regimens threaten to cap growth. Pricing pressures and patent expirations in the coming years pose challenges to revenue sustainability. Additionally, safety concerns, notably immune-related adverse events, influence clinician prescribing behavior.

Market Outlook and Future Trends

The outlook for YERVOY suggests a mixed trajectory—robust growth driven by combination strategies and expanded indications, tempered by competitive innovation and biosimilar threats. The global immuno-oncology market is projected to grow at a CAGR of around 10.3% from 2023 to 2030, driven by unmet needs in hard-to-treat cancers and advancements in immune modulation strategies. YERVOY’s position will depend on its ability to integrate these trends effectively.

Emerging combination therapies, including YERVOY plus relatlimab (LAG-3 inhibitor), demonstrate the evolving landscape's complexity. Regulatory decisions favoring combination approaches could fuel additional revenue streams. Conversely, the shift towards personalized medicine and potential biosimilar entry could diminish market dominance.

Key Market Drivers and Barriers

• Drivers: Proven clinical efficacy, expanded indications, combination regimens, increased adoption in first-line settings, and ongoing clinical trials.
• Barriers: Competitive landscape, safety profiles, cost and reimbursement hurdles, patent expirations, and emerging biosimilars.

Conclusion

YERVOY's market dynamics are characterized by transformative immunotherapy success, competitive pressures, and strategic expansion into new tumor types and combinations. Its financial trajectory remains promising but uncertain, contingent upon clinical developments, market access, and competitive innovations. BMS’s ongoing investments in the immuno-oncology pipeline and combination therapies will largely dictate YERVOY’s future market share and profitability.

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Key Takeaways

• YERVOY has revolutionized melanoma treatment and remains central in immuno-oncology, with revenues exceeding $1.5 billion annually.
• Its strategic positioning in combination therapies with nivolumab enhances both efficacy and sales prospects.
• Market growth is supported by expanding indications and ongoing clinical trials but faces competition from newer agents and biosimilars.
• Pricing strategies, reimbursement policies, and regulatory decisions will significantly influence future financial performance.
• The evolving landscape demands continuous innovation, especially in biomarker-driven personalized approaches, to sustain YERVOY’s market relevance.

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FAQs

1. How does YERVOY compare to other immune checkpoint inhibitors in terms of efficacy?
YERVOY primarily targets CTLA-4, showing significant benefits in combination with nivolumab (PD-1 inhibitor) for melanoma and other cancers. While monotherapy has modest efficacy, its combination regimens have demonstrated superior response rates compared to single-agent therapies, but with higher toxicity profiles.

2. What are the primary safety concerns associated with YERVOY?
Immune-related adverse events, including colitis, hepatitis, endocrinopathies, and skin reactions, are prominent. These require vigilant management and impact patient adherence and therapy selection.

3. What is the outlook for biosimilar competition affecting YERVOY?
As a complex biologic, YERVOY currently has limited biosimilar options due to patent protections and manufacturing complexities. However, impending patent expirations could open the market to biosimilars, potentially reducing revenues.

4. How significant are combination therapies involving YERVOY for future revenue growth?
Highly significant. Combinations with nivolumab and emerging agents are responsible for a growing share of sales and are likely to be primary drivers of revenue expansion, especially in first-line indications.

5. What are the key factors influencing YERVOY’s market penetration globally?
Reimbursement policies, clinical guidelines, regulatory approvals, manufacturing capacity, clinician familiarity, and safety profile management influence adoption across different regions.

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Sources
[1] Bristol-Myers Squibb. Annual Reports and Financial Disclosures.
[2] FDA Approvals and Labeling Archives.
[3] Market Research Reports on Immuno-Oncology.
[4] Clinical Trial Data and Publications.