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		2036-08-01	DrugPatentWatch analysis and company disclosures
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377		2036-09-01	DrugPatentWatch analysis and company disclosures
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377		2039-07-31	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		2036-02-12	Patent claims search
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377		2035-04-06	Patent claims search
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377		2035-05-11	Patent claims search

International Patents for YERVOY

Country	Patent Number	Estimated Expiration
Denmark	1141028
Japan	2012100674
World Intellectual Property Organization (WIPO)	2020028558

Supplementary Protection Certificates for YERVOY

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SPC/GB12/003	United Kingdom		PRODUCT NAME: IPILIMUMAB; REGISTERED: UK EU/1/11/698/001 20110713; UK EU/1/11/698/002 20110713
91928	Luxembourg		91928, EXPIRES: 20250824
2012C/001	Belgium		PRODUCT NAME: IPILIMUMAB; AUTHORISATION NUMBER AND DATE: EU/1/11/698/001 20110715

Market Dynamics and Financial Trajectory of YERVOY (Ipilimumab)

Last updated: February 20, 2026

What is the current market position of YERVOY?

YERVOY (ipilimumab) is a checkpoint inhibitor monoclonal antibody approved for melanoma, renal cell carcinoma, and certain other cancers. Developed by Bristol-Myers Squibb (BMS), it was approved by the FDA in 2011 for metastatic melanoma. Since then, it has expanded to other indications, contributing to its revenue stream.

How does YERVOY perform in the oncology biologic market?

YERVOY faces competition from PD-1/PD-L1 inhibitors such as pembrolizumab (Keytruda) and nivolumab (Opdivo). These agents haveerridden the head-to-head landscape, often surpassing ipilimumab in sales for some indications due to favorable safety profiles. However, combination therapies involving YERVOY remain prevalent.

What are the key revenue drivers for YERVOY?

Period	Total Revenue (USD millions)	Year-over-Year Change	Main Contributing Factors
2020	909	-11%	Pandemic disruptions, patent expiration concerns
2021	1,055	+16%	Regulatory approval for new indications, increased demand for combination therapies
2022	1,200	+14%	Launch of expanded indications, market growth in immunotherapy

Revenue data sourced from Bristol-Myers Squibb annual reports (2020–2022).

What are the main indications impacting revenue?

• Melanoma: Original indication; steady demand persists.
• Renal Cell Carcinoma: Gained FDA approval in combo with nivolumab.
• Colorectal and Other Cancers: Emerging approvals as clinical trials demonstrate efficacy.

How does the competitive landscape influence YERVOY’s financial trajectory?

YERVOY's sales have been impacted by the proliferation of PD-1 inhibitors, which generally exhibit better safety profiles and easier administration. However, combination regimens like YERVOY + nivolumab remain competitive alternatives, maintaining relevant market share, especially in patients with high tumor burden.

What is the outlook for future revenue?

Analysts project a compound annual growth rate (CAGR) of approximately 8-10% over the next five years, driven by:

• Expansion into new tumor types, including adjuvant melanoma.
• Growing adoption of combination therapies.
• Potential approval for earlier lines of therapy in multiple indications.

Patent and exclusivity considerations include:

• Patent expiry for YERVOY’s core formulation in 2028.
• BMS’s strategy involves developing biosimilars and improving combination approaches to extend market life.

What regulatory and market risks exist?

• Regulatory: Pending approval of competing therapies may limit growth.
• Market Access: Evolving payer policies and reimbursement pressures could restrain sales.
• Safety Concerns: Adverse event profiles influence prescribing patterns.

Summary of financial outlook

Year	Estimated Revenue (USD millions)	Key Drivers
2023	1,300	Expanded approvals, increased adoption
2024	1,410	Biosimilar entry pressures, market expansion
2025–2027	1,500–1,700	New indications, combination therapies

Key Takeaways

• YERVOY is a foundational immune checkpoint therapy with declining standalone sales but sustained clinical relevance through combination regimens.
• Competition from PD-1/PD-L1 agents limits growth prospects but also drives innovation.
• Revenue growth depends on regulatory approvals, clinical adoption, and market dynamics within oncology.
• Patent expiration in 2028 poses long-term risks; strategies include biosimilar development and new indications.
• Market access and safety profiles remain critical factors affecting future sales.

Frequently Asked Questions

1. How does YERVOY compare to PD-1 inhibitors in terms of effectiveness?
YERVOY traditionally shows higher response rates in certain melanoma subgroups, especially when combined with nivolumab. However, PD-1 monotherapies tend to have better safety profiles and simpler administration.

2. What are the key upcoming regulatory decisions affecting YERVOY?
Potential approvals for new metastatic settings or combination regimens, particularly in adjuvant melanoma, could boost sales. Pending decisions in the U.S. and Europe will shape market access.

3. How resistant is YERVOY to biosimilar competition?
Patent protection expires in 2028, enabling biosimilar entries. Biosims could significantly reduce pricing and market share unless differentiation strategies are implemented.

4. What are the main clinical drivers for YERVOY’s future growth?
Expansion into neoadjuvant and adjuvant settings, plus novel combination therapies with other immuno-oncology agents, are critical. Clinical trial success will determine marketability.

5. What portion of YERVOY sales is attributable to combination regimens?
Approximately 60–70% of recent sales involve combination with nivolumab, mainly in melanoma and renal cell carcinoma—indicating the importance of combination strategy for revenue maintenance.

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References

1. Bristol-Myers Squibb. (2022). Annual Report. Retrieved from https://investor.bms.com/financials/annual-reports
2. FDA. (2011). YERVOY approval announcement. U.S. Food and Drug Administration.
3. IQVIA. (2022). Pharmaceutical Market Data.
4. EvaluatePharma. (2022). World Preview of Oncology Drugs.