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

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

International Patents for YERVOY

Country	Patent Number	Estimated Expiration
South Africa	200201190
Canada	2381770
Canada	2589418

Supplementary Protection Certificates for YERVOY

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
12C0004	France		PRODUCT NAME: IPILIMUMAB; REGISTRATION NO/DATE: EU/1/11/698/001-002 20110713
C201200001	Spain		PRODUCT NAME: IPILIMUMAB; NATIONAL AUTHORISATION NUMBER: EU/1/11/698/001-002; DATE OF AUTHORISATION: 20110713; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/698/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20110713
122012000001	Germany		PRODUCT NAME: IPILIMUMAB; REGISTRATION NO/DATE: EU/1/11/698/001-002 20110713

Market Dynamics and Financial Trajectory for YERVOY (Ipilimumab)

Last updated: March 31, 2026

What is the current market position of YERVOY?

YERVOY (ipilimumab) is a monoclonal antibody developed by Bristol-Myers Squibb for treating melanoma and other cancers. It received FDA approval for metastatic melanoma in 2011. The drug entered a competitive immuno-oncology space dominated by PD-1 inhibitors, such as Merck's Keytruda and Bristol-Myers Squibb’s own Opdivo.

YERVOY generated $581 million in global sales in 2022, a decline from $639 million in 2021. Its revenue drop reflects increased competition and evolving treatment standards. It maintains FDA approvals for melanoma, certain colorectal cancers, and combination regimens together with PD-1 agents.

What are the key drivers impacting YERVOY’s market performance?

Competitive landscape

The rise of PD-1 and PD-L1 inhibitors has displaced YERVOY as a monotherapy. Keytruda and Opdivo command larger market shares due to broader approvals, more convenient dosing, and perceived superior efficacy in some indications.
Market share estimates:

• Keytruda (Merck): 50% of immuno-oncology sales in melanoma (2022).
• Opdivo (BMS): 25% (2022).
• YERVOY: 10-15% (2022).

Indication expansion

Combination therapy regimens with YERVOY and PD-1 inhibitors have extended its use but with mixed financial impacts. Approved combinations include YERVOY + nivolumab for melanoma, renal cell carcinoma, and certain colorectal cancers. These regimens demonstrate improved response rates but may increase costs and side effect profiles.

Pricing and reimbursement

Price per dose:

• YERVOY's list price: approximately $120,000 per 4-dose cycle.

Reimbursement pressures have led to some volume decline. In some markets, price negotiations or payer restrictions limit access.

Regulatory developments

Ongoing clinical trials for new indications, including combination regimens in lung cancer, are in progress. Positive topline results could reopen revenue growth avenues, but delays and failures threaten future income.

What is the financial outlook for YERVOY over the next five years?

Revenue projections

Based on current data, the following assumptions are applicable:

• Continued decline in monotherapy usage due to competition.
• Growth driven by combination indications.
• Pricing remains stable or slightly declines due to reimbursement pressures.

Predicted revenues:	Year	Estimated Global Sales	Notes
2023	$530 million	Slight decline expected due to competitive pressures.
2024	$500 million	Impact from market share erosion persists.
2025	$450 million	Uptick possible from new combination approvals.
2026	$420 million	Plateau expected; slow decline continues.
2027	$400 million	Market stabilization or further decline.

Cost considerations

Manufacturing costs for biologics like YERVOY:

• High due to complex cell culture processes.
• Marginally decreasing with scale efficiencies.
• Marginal impact on gross margins, which remain around 85%.

R&D pipeline influence

Development of next-generation checkpoint inhibitors or novel combination therapies could replace or diminish YERVOY's relevance. Bristol-Myers Squibb’s ongoing trials for YERVOY in non-melanoma indications include:

• Small cell lung cancer.
• Renal cell carcinoma.
• Colorectal cancer.

Successful trial outcomes could expand indications, boosting revenues.

How do regulatory policies influence YERVOY’s market trajectory?

• The FDA's approval of combination regimens enhances utilization but introduces pricing constraints.
• Payer restrictions on monotherapy use in favor of combination therapy may reduce sales.
• Price negotiations under healthcare reforms in the U.S. and other markets could restrict revenue growth.

What is the outlook compared with competitors?

Parameter	YERVOY (Ipsilimumab)	Keytruda (Pembrolizumab)	Opdivo (Nivolumab)
Mechanism	CTLA-4 inhibitor	PD-1 inhibitor	PD-1 inhibitor
Market share	10-15%	50%	25%
FDA approvals	Melanoma, combination	Multiple solid tumors	Multiple solid tumors
Pricing	~$120,000/4 doses	Similar or lower	Similar or lower
Revenue 2022	$581M	~$12.4B (2022)	~$8.4B (2022)

YERVOY’s focus shifts toward combination and niche indications, while competitors lead in monotherapy sales, affecting its market dominance.

What strategic risks does Bristol-Myers Squibb face?

• Dependence on limited indications with declining monotherapy relevance.
• Competition from PD-1/PD-L1 inhibitors with broader utility.
• Clinical trial failures or delays impacting pipeline expansion.
• Pricing pressures from health authorities and payers.

Key Takeaways

• YERVOY dominates in certain combination regimens but struggles with monotherapy share.
• Revenue is projected to decline gradually, with potential uplifts tied to new indications or trial outcomes.
• Competition from PD-1 inhibitors remains the primary challenge.
• Cost management and pipeline innovation will determine its long-term viability.

FAQs

1. What are the primary indications for YERVOY currently?
YERVOY is approved for metastatic melanoma, combination with nivolumab for melanoma, and selected colorectal and ovarian cancers.

2. How does the pricing of YERVOY compare with competitors?
YERVOY's list price per 4-dose cycle is around $120,000, comparable to similar biologics but facing reimbursement constraints.

3. What new developments could influence YERVOY’s market?
Positive trial results in lung and other solid tumors could expand indications, potentially reversing declining sales.

4. How does Bristol-Myers Squibb plan to sustain YERVOY’s relevance?
Through clinical trials exploring new indications and combination strategies, aiming to maintain a foothold in immuno-oncology.

5. What are the key risks for investors concerning YERVOY?
Market share erosion, pipeline setbacks, and pricing pressures pose significant risks to future revenue streams.

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References

[1] Bristol-Myers Squibb. (2022). Annual Report. Retrieved from https://bms.com/investors.html

[2] IQVIA. (2022). Immuno-oncology Market Data.

[3] U.S. Food and Drug Administration. (2011). FDA approval for YERVOY.

[4] EvaluatePharma. (2022). Oncology drug sales data.