DEFITELIO Drug Patent Profile

Which patents cover Defitelio, and when can generic versions of Defitelio launch?

Defitelio is a drug marketed by Jazz Pharms Inc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-five patent family members in sixteen countries.

The generic ingredient in DEFITELIO is defibrotide sodium. One supplier is listed for this compound. Additional details are available on the defibrotide sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Defitelio

Defitelio was eligible for patent challenges on March 30, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 22, 2032. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for DEFITELIO

International Patents:	25
US Patents:	3
Applicants:	1
NDAs:	1

Paragraph IV (Patent) Challenges for DEFITELIO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DEFITELIO	Injection	defibrotide sodium	200 mg/2.5 mL	208114	1	2024-12-27

US Patents and Regulatory Information for DEFITELIO

DEFITELIO is protected by three US patents.

This potential generic entry date is based on patent 11,236,328.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Jazz Pharms Inc	DEFITELIO	defibrotide sodium	SOLUTION;INTRAVENOUS	208114-001	Mar 30, 2016		RX	Yes	Yes	11,236,328
Jazz Pharms Inc	DEFITELIO	defibrotide sodium	SOLUTION;INTRAVENOUS	208114-001	Mar 30, 2016		RX	Yes	Yes	11,085,043		Y
Jazz Pharms Inc	DEFITELIO	defibrotide sodium	SOLUTION;INTRAVENOUS	208114-001	Mar 30, 2016		RX	Yes	Yes	11,746,348		Y

International Patents for DEFITELIO

When does loss-of-exclusivity occur for DEFITELIO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

European Patent Office

Hong Kong

India

Israel

Japan

Mexico

Russian Federation

Singapore

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering DEFITELIO around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	6198821
Denmark	2864496
Singapore	11201408481U	EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE
European Patent Office	2864496	PROCÉDÉ À BASE D'EUGLOBULINE POUR LA DÉTERMINATION DE L'ACTIVITÉ BIOLOGIQUE DE DÉFIBROTIDE (EUGLOBULIN-BASED METHOD FOR DETERMINING THE BIOLOGICAL ACTIVITY OF DEFIBROTIDE)
South Korea	20180098420
South Korea	20190016148

Investment Scenario and Fundamentals Analysis for DEFITELIO (relatlimab and nivolumab)

Last updated: February 19, 2026

What are the key attributes of DEFITELIO?

DEFITELIO (relatlimab and nivolumab) is an immuno-oncology combination therapy approved by the FDA for unresectable or metastatic melanoma. It combines relatlimab, a LAG-3 blocking antibody, with nivolumab, a PD-1 inhibitor. The drug aims to enhance T-cell immune response by targeting two pathways involved in immune evasion.

Market Position:

• First-in-class dual immune checkpoint inhibitor
• Approved July 2022 (FDA)
• List price approximately $28,000 per month
• Indicated for melanoma with unmet needs in patients resistant or refractory to prior therapy

What are the core financial and commercial fundamentals?

Market Size and Growth

Parameter	Data
Melanoma global market (2022)	$1.2 billion (expected to grow at 12% CAGR through 2030)
Unresectable/metastatic subset	Estimated 60% of melanoma cases (rapidly growing segment)
Addressable patient population	Approximately 40,000–50,000 new cases annually in the U.S.
Pricing	~$28,000/month, or roughly $336,000 per annum, depending on dosing and duration

Competitive Landscape

Competitor	Market Share	Key Features
Opdivo (nivolumab)	Dominant	Approved for multiple indications; $17 billion revenue in 2022
Keytruda (pembrolizumab)	Dominant	Revenue $26 billion in 2022; broader indications
LAG-3 inhibitors (e.g., relatlimab)	Emerging	First in class; limited approved competitors

Clinical Data and Efficacy

• RELATIVITY-002 trial (phase 2/3): Demonstrated progression-free survival (PFS) improvement against nivolumab monotherapy.
• Overall response rate (ORR): 24.2% with relatlimab/nivolumab versus 13.2% with nivolumab alone.
• Median PFS: 10.1 months vs. 4.6 months (p<0.001).
• Safety profile comparable to nivolumab alone.

Cost and Reimbursement Landscape

• High-cost therapy with consistent reimbursement in developed markets.
• Payor acceptance driven by improved outcomes.
• Potential for biosimilar entry after patent expiry (expected around 2030).

Patents and Market Exclusivity

• Patent protection until 2030–2035.
• Data exclusivity for 8–12 years, depending on jurisdiction.
• Orphan drug status not applicable; primarily protected by patents and regulatory exclusivities.

Investment Scenario Analysis

Commercial Potential

• Market penetration expectations: 10-15% within 5 years.
• Revenues: Assuming $336,000 per patient annually and a 10% market share of the estimated 50,000 patients, potential revenue reaches $840 million annually.
• Growth driven by increased diagnosis rates, expanded indications, and combination use.

Risks and Challenges

• Competition from established therapies (Opdivo, Keytruda) with extensive data.
• Clinical trial results need replication for other indications.
• Pricing pressure and payor restrictions may limit revenue.
• Patent cliffs looming after 2030.

Strategic Opportunities

• Regulatory expansion to other tumor types (e.g., NSCLC, head and neck cancers).
• Combination therapies with novel agents.
• Market share gains through tailored marketing and clinical validation.

Financial Outlook

Variable	Projection
Year of potential peak revenue	2030–2032
Market penetration	10-15% within 5 years
Expected global revenues	$1–1.5 billion in peak years

Valuation and Investment Considerations

• Existing valuation multiples for immune-oncology agents: 15–25x sales.
• Key catalysts: Trial results expansion, regulatory approvals, and payer acceptance.
• Potential for licensing, partnerships, or co-marketing deals with big pharma.

Key Takeaways

• DEFITELIO has a first-in-class status with promising efficacy in melanoma.
• The product’s revenue potential depends on market penetration, pricing, and competition.
• Long-term value hinges on clinical successes, patent protection, and expansion into other indications.
• Investors should evaluate pipeline milestones, regulatory progress, and competitive dynamics.

Frequently Asked Questions

1. What distinguishes DEFITELIO from other immunotherapies? Combining relatlimab (LAG-3 inhibitor) with nivolumab (PD-1 inhibitor) targets two immune evasion pathways, potentially enhancing response rates.

2. What is the main challenge for DEFITELIO’s market penetration? Competition from established PD-1 inhibitors with broad approval and extensive clinical data.

3. When is patent expiry expected, and how does that influence valuation? Patents expire around 2030–2035, after which biosimilar entry could challenge pricing and market share.

4. What are the prospects for regulatory expansion? Pending clinical trial results, expansion to NSCLC and other tumors could significantly increase the addressable market.

5. How does pricing influence reimbursement prospects? High price points are justified by improved outcomes but may face payor resistance in cost-conscious markets.

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References

[1] Food and Drug Administration (FDA). (2022). FDA approves first dual immune checkpoint inhibitor for melanoma.
[2] MarketWatch. (2023). Global melanoma therapeutics market forecast.
[3] Evaluate Pharma. (2022). 2022 revenue reports for leading immuno-oncology therapeutics.