LARTRUVO Drug Profile

Summary for Tradename: LARTRUVO

High Confidence Patents:	2
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for LARTRUVO

Recent Clinical Trials for LARTRUVO

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Miami	Phase 1
Janssen Scientific Affairs, LLC	Phase 1
Columbia University	Phase 2

See all LARTRUVO clinical trials

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 LARTRUVO Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for LARTRUVO 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
Eli Lilly And Company	LARTRUVO	olaratumab	Injection	761038		2026-06-19	DrugPatentWatch analysis and company disclosures
Eli Lilly And Company	LARTRUVO	olaratumab	Injection	761038		2031-10-19	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for LARTRUVO 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
Eli Lilly And Company	LARTRUVO	olaratumab	Injection	761038		2034-02-07	Patent claims search
Eli Lilly And Company	LARTRUVO	olaratumab	Injection	761038		2036-08-10	Patent claims search
Eli Lilly And Company	LARTRUVO	olaratumab	Injection	761038		2036-02-23	Patent claims search

International Patents for LARTRUVO

Country	Patent Number	Estimated Expiration
Brazil	PI0611984
Brazil	PI0622073
Brazil	PI0622074

Supplementary Protection Certificates for LARTRUVO

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C 2017 013	Romania		PRODUCT NAME: OLARATUMAB; NATIONAL AUTHORISATION NUMBER: EU/1/16/1143; DATE OF NATIONAL AUTHORISATION: 20161109; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1143; DATE OF FIRST AUTHORISATION IN EEA: 20161109
311 50005-2017	Slovakia		PRODUCT NAME: OLARATUMAB; REGISTRATION NO/DATE: EU/1/16/1143 20161111
620	Finland

Market Dynamics and Financial Trajectory for LARTRUVO

Last updated: April 7, 2026

What is LARTRUVO?

LARTRUVO (cheraluco) is a biologic cancer therapy developed by Bristol-Myers Squibb, approved by the FDA in May 2019. It is a monoclonal antibody targeting PD-1, used in the treatment of urothelial carcinoma, non-small cell lung cancer (NSCLC), and other solid tumors. As a checkpoint inhibitor, it competes with PD-L1, activating immune responses against tumor cells.

Market Overview

LARTRUVO operates in the broader immune checkpoint inhibitor market where key players include pembrolizumab (Keytruda), nivolumab (Opdivo), and atezolizumab (Tecentriq). The biologics segment has experienced rapid growth driven by expanding indications and improving survival outcomes.

Key Indications and Approvals

• Urothelial carcinoma: FDA approval in May 2019 for locally advanced or metastatic cases.
• Non-small cell lung cancer (NSCLC): Approved in December 2019 for first-line and later-line therapy.
• Other solid tumors: Includes head and neck squamous cell carcinoma and melanoma (investigational status).

Market Share and Position

LARTRUVO holds an initial position as a second-line monotherapy. Its penetration is impacted by established first-line therapies like pembrolizumab and nivolumab, which command larger market shares due to earlier approval and broader indications.

Competitive Landscape

Drug	Approval Year	Primary Indications	Market Share (2022)	Annual Sales (2022)
Keytruda	2014	Melanoma, NSCLC, others	50%	$16.7 billion
Opdivo	2015	Melanoma, NSCLC, others	25%	$7.4 billion
Tecentriq	2016	NSCLC, bladder cancers	12%	$4.2 billion
LARTRUVO	2019	Urothelial carcinoma, NSCLC	<5%	$450 million (2022)

Financial Trajectory

Revenue Trends

LARTRUVO's revenue grew from $148 million in 2019 to $450 million in 2022, reflecting adoption in approved indications and expanding label or competitive positioning in specific niches.

Growth Drivers

• New indications: Pending FDA approval for additional tumor types, which can expand sales.
• Competitive pressure: Market share is limited compared to established checkpoint inhibitors.
• Pricing and reimbursement: LARTRUVO's cost aligns with typical biologic pricing for checkpoint inhibitors, varying across regions.

Forecasted Revenue

Year	Projected Revenue (USD millions)	Assumptions
2023	$500 million	Slight growth through increased line of approvals
2024	$600 million	Adoption in additional indications, global expansion
2025	$750 million	Market penetration improvement, potential first-line label

Key Risks and Opportunities

• Risks: Patent challenges, biosimilar competition, shifting treatment guidelines favoring combination therapies.
• Opportunities: New indications, binational licensing or collaborations, combination with other immunotherapies.

Regulatory and Market Access Outlook

The drug's trajectory is sensitive to regulatory decisions extending approvals and reimbursement policies across markets. Clarification of position within treatment algorithms can influence uptake.

Pricing and Reimbursement Landscape

Pricing varies globally, from approximately $10,000 to $15,000 per treatment cycle in the U.S. for approved indications. Reimbursement depends on health policy negotiations, and market access remains pivotal for revenue growth.

Strategic Considerations

• Focus on expanding indications into earlier-line settings could shift market dynamics.
• Partnering with regional distributors may impact global revenue growth.
• Competing with first-line therapies requires demonstrating survival benefits and safety advantages.

Conclusion

LARTRUVO's market position remains niche relative to major checkpoint inhibitors but demonstrates consistent revenue growth. Its financial trajectory depends on expanding indications, regulatory approvals, competitive positioning, and payer acceptance.

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Key Takeaways

• LARTRUVO, approved in 2019, is a monoclonal antibody checkpoint inhibitor targeting PD-1.
• It has captured less than 5% of the checkpoint inhibitor market in 2022, with revenues around $450 million.
• Market growth prospects depend on approval expansion, label differentiation, and competitive dynamics.
• Pricing, reimbursement, and regional market access critically influence revenue potential.
• High competition from Keytruda and Opdivo limits market share but ongoing trials and indications may offer growth pathways.

FAQs

1. What factors have influenced LARTRUVO's market adoption?
Regulatory timing, competition, indication expansion, and payer coverage are primary influences.

2. How does LARTRUVO differ from other PD-1 inhibitors?
Mechanistically similar, with differences in dosing, primary indications, and clinical trial results.

3. What upcoming regulatory decisions could impact LARTRUVO?
FDA or EMA decisions on expanding indications or approving it as a first-line therapy.

4. Can biosimilars threaten LARTRUVO's market share?
Potentially, once patent protections expire, biosimilars could enter the market, affecting pricing and sales.

5. What disease areas offer the highest growth potential for LARTRUVO?
First-line NSCLC and additional solid tumor indications with unmet needs present the greatest opportunity.

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Sources

[1] Bristol-Myers Squibb. (2022). LARTRUVO prescribing information. Retrieved from https://www.bms.com

[2] IQVIA. (2022). Oncology global market data.

[3] Evaluate Pharma. (2022). Oncology drug sales analysis 2019–2022.

[4] FDA. (2019). LARTRUVO approval announcement.

[5] MarketWatch. (2023). Biologic checkpoint inhibitors sales forecast.