LENVIMA Drug Patent Profile

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

Lenvima is a drug marketed by Eisai Inc and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and three patent family members in thirty-seven countries.

The generic ingredient in LENVIMA is lenvatinib mesylate. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lenvatinib mesylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Lenvima

Lenvima was eligible for patent challenges on February 13, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 26, 2036. This may change due to patent challenges or generic licensing.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (lenvatinib mesylate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for LENVIMA

International Patents:	203
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	54
Patent Applications:	1,268
Drug Prices:	Drug price information for LENVIMA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LENVIMA
What excipients (inactive ingredients) are in LENVIMA?	LENVIMA excipients list
DailyMed Link:	LENVIMA at DailyMed

See drug prices for LENVIMA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LENVIMA

NDA:

206947

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for LENVIMA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University Medical Center Groningen	Phase 4
Tongji Hospital	Phase 3
University of California, San Francisco	Phase 2

See all LENVIMA clinical trials

Pharmacology for LENVIMA

Drug Class	Kinase Inhibitor
Mechanism of Action	Receptor Tyrosine Kinase Inhibitors

Paragraph IV (Patent) Challenges for LENVIMA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LENVIMA	Capsules	lenvatinib mesylate	4 mg and 10 mg	206947	2	2019-02-13

US Patents and Regulatory Information for LENVIMA

LENVIMA is protected by nine US patents and four FDA Regulatory Exclusivities.

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
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-001	Feb 13, 2015		RX	Yes	No					Y
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-002	Feb 13, 2015		RX	Yes	Yes					Y
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-002	Feb 13, 2015		RX	Yes	Yes

International Patents for LENVIMA

When does loss-of-exclusivity occur for LENVIMA?

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

Argentina

Australia

Brazil

Canada

China

Croatia

Denmark

European Patent Office

Hungary

Israel

Japan

Jordan

Lithuania

Mexico

Poland

Portugal

Russian Federation

San Marino

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

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 LENVIMA around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	112017002827
Hungary	E064614
Lithuania	3524595

Supplementary Protection Certificates for LENVIMA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1415987	92858	Luxembourg		PRODUCT NAME: LENVATINIB, OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU UN HYDRATE DE CELUI-CI
1415987	57/2015	Austria		PRODUCT NAME: LENVATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON ODER EIN HYDRAT DAVON; REGISTRATION NO/DATE: EU/1/15/1002/001-002 (MITTEILUNG) 20150601
1415987	CA 2015 00053	Denmark		PRODUCT NAME: LENVATINIB, ELLER ET FARMAKOLOGISK ACCEPTABELT SALT DERAF ELLER ET HYDRAT, HERUNDER LEVATINIB MESILAT; REG. NO/DATE: EU/1/15/1002/001-002 20150601

Market Dynamics and Financial Trajectory of LENVIMA (Lenvatinib)

Last updated: November 19, 2025

Introduction

LENVIMA (lenvatinib), developed by Eisai Co., Ltd., is an orally active multi-kinase inhibitor approved for multiple oncological indications. Its versatile mechanism targeting tumor angiogenesis and proliferation has positioned lenvatinib as a cornerstone in the targeted cancer therapy landscape. This analysis explores the evolving market dynamics, competitive positioning, regulatory landscape, and financial trajectory shaping LENVIMA’s future prospects.

Pharmacological Profile and Therapeutic Indications

LENVIMA’s mechanism involves inhibiting vascular endothelial growth factor receptors (VEGFR 1-3), fibroblast growth factor receptors (FGFR 1-4), and other kinases relevant to tumor growth. Its approvals span several major indications:

• Radioiodine-refractory differentiated thyroid cancer (RR-DTC)
• Advanced renal cell carcinoma (RCC)
• Hepatocellular carcinoma (HCC)
• Endometrial carcinoma (ET) in combination with Pembrolizumab

The drug’s molecular profile underpins its expansion potential, especially as combination therapies gain traction in oncology.

Market Dynamics

1. Expanding Indications and Clinical Evidence

LENVIMA’s approval expansions are driven by robust clinical trial outcomes. Notably:

• The REFLECT trial demonstrated non-inferiority of LENVIMA to sorafenib in HCC, fueling its market growth.
• The LEAP-005 trial with pembrolizumab enhanced its position in combination regimens, favorable for HCC and other solid tumors.
• Ongoing trials investigate its efficacy in non-small cell lung cancer (NSCLC), gastrointestinal stromal tumors (GIST), and endometrial cancers, promising diversification.

2. Competitive Landscape

LENVIMA faces competition from several multi-kinase inhibitors: sunitinib, pazopanib, cabozantinib, and emerging agents such as tivozanib. The key differentiator lies in its demonstrated efficacy in refractory thyroid cancers and HCC, coupled with promising combination studies.

The carve-out of definitive positions in RCC and HCC depends on continued positive phase III results and real-world effectiveness data, especially as new agents like sorafenib and cabozantinib hold FDA approvals for similar indications.

3. Regulatory and Pricing Strategies

Regulatory agencies in the U.S., EU, and Asia have granted approvals for multiple indications. Takings advantage of accelerated pathways, with Breakthrough Therapy Designations and Orphan Drug Status, the company has expedited access with reduced development timelines.

Pricing strategies significantly influence market penetration. LENVIMA’s premium pricing is justified by its clinical benefits, although price negotiations in managed markets and cost-effectiveness evaluations pose challenges.

4. Geographic Market Expansion

While North America dominates sales, notable growth in Asia, particularly Japan and China, is crucial, given their sizable patient populations and government initiatives prioritizing cancer care. Differing regulatory hurdles and reimbursement landscapes require adaptive strategies.

5. Patent and Exclusivity Landscape

LENVIMA’s primary patents extend into the early 2030s, with secondary patents targeting formulations and methods to extend exclusivity. Patent challenges or generic entrants could impact revenue streams post-expiration, contingent on lifecycle management strategies.

Financial Trajectory

1. Revenue Growth and Market Penetration

In 2022, Eisai reported global sales of approximately $1.5 billion for LENVIMA, representing a compound annual growth rate (CAGR) of around 20% over the past five years. The growth was driven by:

• Increased adoption in RCC and HCC.
• Uptake of combination therapies involving immune checkpoint inhibitors.
• Regulatory approvals in additional territories.

2. Pipeline Contributions and Strategic Collaborations

The drug’s revenue prospects hinge on ongoing trial successes and strategic alliances:

• The collaboration with Merck in exploring LENVIMA plus Pembrolizumab combinations extends potential indications and elevates revenue prospects.
• Pipeline candidates, including next-generation formulations and combination regimens, are anticipated to contribute significant future sales.

3. Cost Structure and Investment

Eisai's investments in R&D for combination therapies and biomarker development aim to optimize patient stratification and therapy efficacy, translating into higher affordability and market share. Operating expenses are balancing increased R&D investments with disciplined commercialization.

4. Market Challenges Impacting Financials

Potential hurdles include:

• Patent cliffs post-2030 could open competitive pressures.
• Pricing pressures amid healthcare reforms and negotiations.
• Clinical trial outcomes that may alter the drug’s approved indications or safety profiles.

5. Long-term Forecast and Revenue Outlook

Based on current trends, analysts project:

• 2023-2025 CAGR of 12-15% in global sales.
• With inclusion in combination regimens, peak sales could surpass $3 billion annually by 2030.
• Escalated use in Asia and Europe will underpin sustained growth.

Regulatory and Market Risks

Regulatory delays or sanctioning modifications, especially in emerging markets, remain imminent risks. Additionally, reimbursement hurdles and competitive breakthroughs could hamper planned expansion. The emergence of next-generation kinase inhibitors and immune therapies may also reshape the competitive landscape.

Conclusion

LENVIMA’s market and financial outlook is marked by dynamic growth, driven by expanding indications, strategic collaborations, and ongoing clinical validation. Its positioning as a multi-kinase inhibitor with versatility in oncologic treatment paradigms affords significant upside potential, tempered by patent expirations and competitive forces.

Continued innovation, geographic expansion, and effective lifecycle management will be critical for sustaining and enhancing its market trajectory.

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Key Takeaways

• Diversification and Expansion: Clinical success in multiple cancers and combination therapies are vital to sustain growth trajectories.
• Competitive Positioning: Differentiation through efficacy, planned regulatory extensions, and strategic partnerships is critical.
• Market Expansion: Focus on Asian markets and collaborations will significantly influence revenue growth.
• Financial Outlook: Peak sales forecasts suggest robust long-term potential, contingent upon successful pipeline navigation and patent management.
• Risks Management: Patent expiries, reimbursement policies, and clinical trial outcomes remain key considerations.

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Frequently Asked Questions (FAQs)

1. What are the primary indications driving LENVIMA’s sales growth?
LENVIMA’s major revenue drivers include refractory thyroid cancer, RCC, and HCC, supported by pivotal clinical trial data and regulatory approvals in these areas.

2. How does LENVIMA compare to other multi-kinase inhibitors in the market?
LENVIMA distinguishes itself through demonstrated efficacy in specific refractory cancers, especially thyroid and HCC, and its potential in combination regimens, though it faces stiff competition from established agents like sorafenib and cabozantinib.

3. What are the key risks facing LENVIMA’s future market performance?
Patent expirations, emerging competitors, regulatory challenges, and reimbursement constraints pose notable risks to sustained market share and revenue growth.

4. Which regions offer the highest growth prospects for LENVIMA?
North America and Asia are primary markets, with China and Japan offering substantial long-term growth due to sizable patient populations and supportive regulatory frameworks.

5. What is the outlook for LENVIMA’s revenues over the next five years?
Projected annual revenues are expected to grow at a CAGR of around 12-15%, potentially exceeding $3 billion by 2030, driven by indication expansion and global adoption.

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Sources
[1] Eisai Co., Ltd. Annual Reports 2022
[2] FDA and EMA approvals and label information
[3] ClinicalTrials.gov database for ongoing studies
[4] Market research reports detailing oncology drug trends