Ipilimumab - Biologic Drug Details

Summary for ipilimumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for ipilimumab

Recent Clinical Trials for ipilimumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Guliz Ozgun	PHASE3
Federation Francophone de Cancerologie Digestive	PHASE2
British Columbia Cancer Agency	PHASE3

See all ipilimumab clinical trials

Pharmacology for ipilimumab

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 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 ipilimumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ipilimumab 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
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377		2020-08-24	DrugPatentWatch analysis and company disclosures
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377		2023-08-26	DrugPatentWatch analysis and company disclosures
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377		2027-10-31	DrugPatentWatch analysis and company disclosures
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377		2029-09-22	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for ipilimumab 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
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377		2033-08-30	Patent claims search
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377		2034-02-07	Patent claims search
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377		2035-07-16	Patent claims search
Bristol-myers Squibb Company	YERVOY	ipilimumab	Injection	125377		2037-06-19	Patent claims search

International Patents for ipilimumab

Country	Patent Number	Estimated Expiration
Germany	69942037
Japan	5599158
Croatia	P20130077
Israel	280414
Slovenia	1141028
South Africa	202100780
Mexico	PA02001911

Supplementary Protection Certificates for ipilimumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
122012000001	Germany		PRODUCT NAME: IPILIMUMAB; REGISTRATION NO/DATE: EU/1/11/698/001-002 20110713
132012902011949	Italy		PRODUCT NAME: IPILIMUMAB(YERVOY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/698/001-002, 20110713
12C0004	France		PRODUCT NAME: IPILIMUMAB; REGISTRATION NO/DATE: EU/1/11/698/001-002 20110713
91928	Luxembourg		91928, EXPIRES: 20250824
SPC/GB12/003	United Kingdom		PRODUCT NAME: IPILIMUMAB; REGISTERED: UK EU/1/11/698/001 20110713; UK EU/1/11/698/002 20110713
C300511	Netherlands		PRODUCT NAME: IPILIMUMAB; REGISTRATION NO/DATE: EU/1/11/698/001-002 20110713
2012C/001	Belgium		PRODUCT NAME: IPILIMUMAB; AUTHORISATION NUMBER AND DATE: EU/1/11/698/001 20110715

Market Dynamics and Financial Trajectory for Ipilimumab

Last updated: March 13, 2026

Ipilimumab, marketed as Yervoy, is a CTLA-4 immune checkpoint inhibitor approved for melanoma treatment. Its market position depends on competitive advances, regulatory actions, and evolving treatment protocols.

Market Size and Growth Drivers

The global immunotherapy market is projected to reach USD 169 billion by 2028, growing at a CAGR of 11% from 2021 (Fortune Business Insights, 2021). Ipilimumab contributes to this growth as an early immune checkpoint inhibitor.

• Initial approval (2011): FDA approved for unresectable or metastatic melanoma.
• Additional indications: Approved for microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer (2017), and combination therapy with nivolumab for intermediate or poor-risk advanced melanoma (2015).

Revenue and Sales Trends

Year	Estimated Global Sales (USD Million)	Notes
2015	430	Growth driven by melanoma indications
2018	662	Expansion into kidney and lung oncology
2020	720	Market saturation and increased competition
2022	650	Slight decline with emerging competitors

Sales data sources: EvaluatePharma, 2022; IQVIA, 2022.

Competitive Landscape

Ipilimumab's main competitors include pembrolizumab (Keytruda), nivolumab (Opdivo), and emerging bispecific antibodies. Nivolumab and pembrolizumab simulate checkpoint inhibition through PD-1 targeting, showing higher response rates and fewer side effects.

• Market share (2022): Nivolumab (35%), Pembrolizumab (30%), Ipilimumab (15%), Others (20%) (IQVIA, 2022).
• Pricing: Approximate USD 120,000 per patient course, variable by indication and payer negotiations.

Regulatory and Clinical Development Trends

• Recent approvals include combination regimens, such as nivolumab + ipilimumab for malignant pleural mesothelioma.
• Ongoing clinical trials explore combinatorial approaches to extend utility in renal cell carcinoma and non-small cell lung cancer.
• Regulatory hurdles concern toxicity profiles, particularly immune-related adverse events needing management strategies.

Financial Trajectory Projection

• Short-term (1-3 years): Slight revenue decline expected due to patent expiry of initial indications in 2028, increased competition, and high drug cost pressures.
• Medium-term (3-5 years): Diversification into early-line combination regimens with popular agents may offset patent expirations.
• Long-term (5+ years): Revenue depends on success in expanding indications and potential label expansions; biosimilars could reduce prices and impact profitability.

Patent Status and Market Exclusivity

• Primary patents expired in 2028, leading to imminent biosimilar competition.
• Patent extensions possible through formulation or dosing method patents.

Key Market Risks

• Emergence of effective PD-1 inhibitors.
• Regulatory constraints on combination therapy toxicity.
• Pricing pressures from payers and healthcare systems.

Strategic Considerations

• Developing novel combinations.
• Entering new oncology indications.
• Enhancing biomarker-driven patient selection to improve response rates and market penetration.

Key Takeaways

Ipilimumab holds a significant position within the immune checkpoint inhibitor landscape. Revenue peaked around 2018, with sales plateauing recently amid growing competition and patent expiration looming. Its future depends on expanding indications, developing combination therapies, and navigating regulatory and pricing challenges.

Frequently Asked Questions

1. How does Ipilimumab compare with PD-1 inhibitors in efficacy?
Ipilimumab shows comparable efficacy in melanoma, but PD-1 inhibitors often have better tolerability and response rates, leading to their preference in first-line settings.

2. What is the projected impact of biosimilars?
Biosimilars could reduce prices by 20-30%, compressing profit margins starting from 2028 when primary patents expire.

3. Are there new indications under development?
Yes, trials are ongoing for combinations in lung, kidney, and colorectal cancers, aiming to expand its treatable populations.

4. How important is biomarker testing for Ipilimumab therapy?
Biomarker testing, particularly for MSI-H and dMMR, guides treatment decisions, optimizing outcomes and market segmentation.

5. What are the main challenges for Ipilimumab’s market growth?
Main challenges include competition, toxicity management, biosimilar entry, and cost containment pressures.

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References

1. Fortune Business Insights. (2021). Global Immunotherapy Market Size, Share & Industry Analysis, 2021-2028.
2. IQVIA. (2022). The IQVIA Biotech Market Indicators.
3. EvaluatePharma. (2022). Proven global pharmaceutical sales reports.