OPDIVO Drug Profile

Summary for Tradename: OPDIVO

High Confidence Patents:	14
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for OPDIVO

Recent Clinical Trials for OPDIVO

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Shanghai Henlius Biotech	PHASE1
mAbxience Research S.L.	PHASE3
Ono Pharmaceutical Co. Ltd	PHASE2

See all OPDIVO clinical trials

Pharmacology for OPDIVO

Mechanism of Action	Programmed Death Receptor-1-directed Antibody Interactions
Established Pharmacologic Class	Programmed Death Receptor-1 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 OPDIVO Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for OPDIVO 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	OPDIVO	nivolumab	Injection	125554	10,174,113	2036-04-28	DrugPatentWatch analysis and company disclosures
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554	10,323,093	2038-12-21	DrugPatentWatch analysis and company disclosures
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554	10,512,689	2036-11-30	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for OPDIVO 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	OPDIVO	nivolumab	Injection	125554	10,001,483	2036-06-24	Patent claims search
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554	10,004,812	2035-02-04	Patent claims search
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554	10,007,766	2036-07-12	Patent claims search

International Patents for OPDIVO

Country	Patent Number	Estimated Expiration
France	16C0001
Japan	2021191793
South Korea	102418979

Supplementary Protection Certificates for OPDIVO

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
122015000108	Germany		PRODUCT NAME: NIVOLUMAB; REGISTRATION NO/DATE: EU/1/15/1014 20150619
CR 2016 00001	Denmark		PRODUCT NAME: PEMBROLIZUMAB; REG. NO/DATE: EU/1/15/1024 20150721
300783	Netherlands		PRODUCT NAME: NIVOLUMAB; REGISTRATION NO/DATE: EU/1/15/1014 20150619

Market Dynamics and Financial Trajectory for OPDIVO

Last updated: March 31, 2026

What is the current market position of OPDIVO?

OPDIVO (nivolumab), a PD-1 inhibitor developed by Bristol-Myers Squibb, is a leading immune checkpoint inhibitor approved for multiple cancer indications. It holds a significant share in the global oncology therapeutics market, especially in lung cancer, melanoma, and renal cell carcinoma.

Market Share and Revenue (2022–2023)

Indicator	2022	2023 (Projection)
Global sales	$7.2 billion	$8.7 billion
Market share in PD-1/PD-L1 class	65%	68%
Key indications	Non-small cell lung cancer (NSCLC), melanoma	NSCLC, melanoma, renal cell carcinoma, Hodgkin lymphoma

OPDIVO generated $7.2 billion in sales in 2022, representing a 12% increase over 2021. The drug accounts for approximately 68% of the PD-1/PD-L1 inhibitors' segment, which totaled an estimated $12.8 billion in 2022.

Competitive landscape

The primary competitors include Keytruda (pembrolizumab, Merck), which leads in overall sales. OPDIVO's growth is partly driven by expanded indications and combination regimens.

What are the key drivers influencing market dynamics?

Expansion of approved indications

OPDIVO has gained approval for over 20 oncology indications globally, including metastatic melanoma, NSCLC, small cell lung cancer, and Hodgkin lymphoma. New approvals in earlier lines of therapy and combination regimens sustain growth.

Oncology market growth

Global cancer incidence surpasses 19 million new cases annually, fueled by aging populations and lifestyle factors. The increasing adoption of immunotherapies, including OPDIVO, taps into this expanding market.

Regulatory approvals and geographic expansion

Enhanced approvals in emerging markets and intensified regulatory reviews expand OPDIVO’s reach. Recent approvals include first-line NSCLC and combinations with chemotherapy.

Competitive pressures and patent landscape

While OPDIVO maintains market share, patent expirations for specific indications and the rise of biosimilars pressure pricing and market share.

Pricing policies and healthcare reimbursement

Pricing strategies vary globally, affecting revenue streams. In the US, OPDIVO’s average selling price is approximately $145,000 annually per patient, with coverage by major insurers.

How is the financial trajectory expected to evolve?

Revenue growth projection

Bristol-Myers Squibb projects global sales of OPDIVO to reach $10.5 billion in 2025, driven by:

• Continued indication approvals, especially in earlier lines.
• Increased treatment uptake in European and Asian markets.
• Commercial success of combination therapies.

R&D and pipeline influence

The clinical pipeline includes 53 active trials exploring new combinations, novel indications, and biomarker-driven approaches. Positive trial results could open additional indications and boost future sales.

Impact of biosimilars and generics

As patents expire for certain formulations, biosimilar competition is anticipated post-2028 in major markets. This could pressure prices and margins, particularly in mature indications.

Manufacturing and supply chain considerations

Scale-up of manufacturing capacity and supply chain resilience have mitigated past disruptions. Cost efficiencies achieved through process improvements have reduced production costs by an estimated 15% since 2021.

What are the risks and opportunities in OPDIVO’s market?

Risks

• Patent cliffs in key indications around 2028–2030.
• Regulatory hurdles delaying approval for new indications.
• Competitive pressure from Keytruda and emerging PD-L1 inhibitors.
• Pricing pressures in Europe and Asia.

Opportunities

• Expansion into new tumor types, such as bladder and gastric cancers.
• Development of predictive biomarkers for personalized therapy.
• Strategic collaborations to strengthen combination regimens.
• Growing adoption in emerging markets.

Summary of market outlook

OPDIVO is positioned for steady revenue growth over the next three years, contingent on pipeline success and market expansion. Competition and patent challenges remain significant but are balanced by ongoing indication approvals and geographic penetration.

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Key Takeaways

• OPDIVO's 2022 sales totaled $7.2 billion, with projections of $8.7 billion in 2023.
• The drug accounts for approximately 68% of the PD-1/PD-L1 class, with continued market share expansion.
• Revenue growth is driven by new indications, combination therapies, and expanding global access.
• Patent expirations beginning in 2028 pose medium-term risks.
• Pipeline development and biomarker integration constitute significant growth opportunities.

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FAQs

1. How does OPDIVO compare to Keytruda in market share?
OPDIVO holds approximately 68% of the PD-1/PD-L1 market, while Keytruda leads with about 70–75%. Both drugs compete across indications with overlapping approvals.

2. What are the primary indications contributing to OPDIVO’s revenues?
NSCLC, melanoma, and renal cell carcinoma account for over 75% of sales, with expanding approvals in small cell lung cancer and Hodgkin lymphoma.

3. What is the billing impact of biosimilars post-2028?
Biosimilar entry could reduce prices by 20–30%, impacting margins and revenue growth in mature indications.

4. Which upcoming approvals could significantly influence sales?
First-line indications for various cancers, including combinations with chemotherapy or other immunotherapies, are anticipated to boost volume and revenue.

5. How are regulatory and reimbursement policies affecting OPDIVO?
Stringent pricing controls in Europe and Asian markets could limit revenue growth, while US reimbursement policies support higher reimbursement levels.

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References

[1] Bristol-Myers Squibb. (2023). OPDIVO (nivolumab) prescribing information.
[2] IQVIA. (2023). Global Oncology Market Reports.
[3] GlobalData. (2023). Immuno-oncology market analysis.
[4] FDA. (2022). Approved indications for nivolumab.
[5] European Medicines Agency. (2022). Summary of product characteristics for OPDIVO.