Lenvatinib mesylate - Generic Drug Details

What are the generic sources for lenvatinib mesylate and what is the scope of patent protection?

Lenvatinib mesylate is the generic ingredient in one branded drug marketed by Eisai Inc and is included in one NDA. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lenvatinib mesylate has two hundred and three patent family members in thirty-seven countries.

There are three drug master file entries for lenvatinib mesylate. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for lenvatinib mesylate

International Patents:	203
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	14
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lenvatinib mesylate
DailyMed Link:	lenvatinib mesylate at DailyMed

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

Constraining patent/regulatory exclusivity:

10,259,791*PED

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 lenvatinib mesylate

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

Sponsor	Phase
Beijing Tsinghua Chang Gung Hospital	NA
Henan Cancer Hospital	Phase 2
Shanghai Junshi Bioscience Co., Ltd.	Phase 3

See all lenvatinib mesylate clinical trials

Generic filers with tentative approvals for LENVATINIB MESYLATE

Applicant	Application No.	Strength	Dosage Form
		10MG	CAPSULE; ORAL
		4MG	CAPSULE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for lenvatinib mesylate

Drug Class	Kinase Inhibitor
Mechanism of Action	Receptor Tyrosine Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for lenvatinib mesylate

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for LENVATINIB MESYLATE

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 lenvatinib mesylate

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	206947-002	Feb 13, 2015		RX	Yes	Yes	10,407,393*PED				Y
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-002	Feb 13, 2015		RX	Yes	Yes
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-002	Feb 13, 2015		RX	Yes	Yes	10,259,791*PED				Y
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-002	Feb 13, 2015		RX	Yes	Yes
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-002	Feb 13, 2015		RX	Yes	Yes
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-001	Feb 13, 2015		RX	Yes	No	12,083,112*PED				Y

International Patents for lenvatinib mesylate

Country	Patent Number	Title	Estimated Expiration
Japan	WO2016031841
Serbia	63559	DERIVAT HINOLINA VELIKE ČISTOĆE I POSTUPAK ZA NJEGOVU PROIZVODNJU (HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME)
World Intellectual Property Organization (WIPO)	2016031841
Slovenia	1698623
European Patent Office	4089076
San Marino	T202200367

Supplementary Protection Certificates for lenvatinib mesylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1698623	PA2015039,C1698623	Lithuania		PRODUCT NAME: LENVATINIBAS; REGISTRATION NO/DATE: EU/1/15/1002/001 - 002 20150528
1698623	261 5023-2015	Slovakia		PRODUCT NAME: LENVATINIB MESYLAT; REGISTRATION NO/DATE: EU/1/15/1002/001 - EU/1/15/1002/002 20150601
1415987	CR 2015 00053	Denmark		PRODUCT NAME: LENVATINIB, ELLER ET FARMAKOLOGISK ACCEPTABELT SALT DERAF ELLER ET HYDRAT DERAF, HERUNDER LENVATINIB MESILAT; REG. NO/DATE: EU/1/15/1002/001-002 20150601
1415987	132016000024218	Italy		PRODUCT NAME: LENVATINIB O UN SUO SALE ACCETTABILE FARMACEUTICAMENTE O SUO IDRATO(LENVIMA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1002/001-002, 20150601
1415987	300764	Netherlands		PRODUCT NAME: LENVATINIB, EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1002/001 -002 20150528
1415987	1590053-3	Sweden		PRODUCT NAME: LENVATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REG. NO/DATE: EU/1/15/1002 20150601

Market Dynamics and Financial Trajectory for Lenvatinib Mesylate

Last updated: August 21, 2025

Introduction

Lenvatinib mesylate, marketed primarily under the brand name Lenvima, represents a significant advancement in targeted cancer therapy. Approved by the FDA in 2015 for differentiated thyroid cancer, its indications expanded to include unresectable hepatocellular carcinoma, renal cell carcinoma, and endometrial carcinoma. As an oral multi-kinase inhibitor, it disrupts tumor angiogenesis and proliferation by targeting vascular endothelial growth factor (VEGF) receptors among other kinases. Its evolving portfolio and competitive landscape highlight complex market dynamics and an anticipated robust financial trajectory within the oncology sector.

---

Market Overview and Current Landscape

Global Oncology Drug Market Context

The global oncology therapeutics market is projected to reach over USD 244 billion by 2028, growing at a CAGR of approximately 7%[1]. Rising cancer prevalence, advancements in personalized medicine, and increased regulatory approvals underpin this expansion. Lenvatinib fits into this high-growth environment as an agent targeting multiple tumor pathways, offering therapeutic advantages over traditional chemotherapies.

Approved Indications and Market Penetration

Lenvatinib's initial approval targeted differentiated thyroid cancer refractory to radioactive iodine. Subsequent approvals for hepatocellular carcinoma, renal cell carcinoma, and endometrial carcinoma have broadened its market reach, supported by compelling Phase III trial data demonstrating improved progression-free survival (PFS)[2]. Its oral administration offers convenience, contributing to patient adherence, further bolstering its market share.

Competitive Landscape

Lenvatinib faces competition from other multi-kinase inhibitors, such as sorafenib (Nexavar) and cabozantinib (Cabometyx), along with immune checkpoint inhibitors gaining ground in oncology. Despite competition, its unique multi-indication approval profile offers a diversified revenue base. Additionally, strategic collaborations and licensing agreements, notably with Eisai and Merck, reinforce its market positioning.

---

Market Dynamics Influencing Lenvatinib’s Trajectory

Clinical Efficacy and Safety Profiles

Lenvatinib’s efficacy across multiple tumor types, coupled with its tolerability profile, critically influences its market adoption. Real-world data reinforce its comparative benefits, especially in hepatocellular carcinoma, where survival benefits exceed existing therapies in certain subpopulations[3]. Ongoing studies evaluating combinations with immunotherapies, such as pembrolizumab, may further enhance its efficacy, expanding its market potential.

Regulatory Environment and Approvals

Regulatory agencies globally show increasing acceptance of targeted therapies with scarce or limited options for advanced cancers. Accelerated approvals and orphan drug designations facilitate market entry in emerging markets. For instance, the European Medicines Agency (EMA) has approved Lenvitinib for hepatocellular carcinoma, providing access outside the US, further widening its revenue horizon.

Pricing Strategies and Reimbursement Policies

Pricing and reimbursement significantly impact pharmaceutical revenues. Lenvatinib’s list prices align with other targeted agents, but regional reimbursement policies influence access. Biosimilar and generic competition, although limited for small-molecule kinase inhibitors, pose potential price erosion pressures as patents expire, notably following patent protections in key markets.

Innovative Combination Therapies and Pipeline Development

Lenvatinib’s synergy with immune checkpoint inhibitors is at the forefront of clinical research, promising to transform its therapeutic landscape. Positive trial results, like the LEAP-002 trial combining with pembrolizumab in hepatocellular carcinoma, could unlock new indications and markets, markedly influencing its financial outlook[4].

Market Growth Opportunities and Emerging Territories

Developing markets, constrained historically by cost barriers, are increasingly accessible through strategic pricing and partnerships. The growing cancer burden in Asia-Pacific and Latin America presents opportunities for expansion, especially as healthcare infrastructure improves.

---

Financial Trajectory Outlook

Revenue Projections

Based on current approvals, pipeline progress, and clinical data, analysts estimate Lenvatinib’s global sales to surpass USD 3 billion annually by 2030. The majority of revenue will emanate from the US, China, and Europe, with significant upside from combination therapies and expanding indications.

Revenue Drivers

• Market Penetration & Adoption: Increased adoption in existing indications.
• Pipeline Progress: Positive trial outcomes in additional tumor types will catalyze new revenue streams.
• Geographical Expansion: Entry into untapped emerging markets.
• Pricing & Reimbursement: Optimization in high-income regions and strategic negotiations.

Risks and Challenges

• Patent Expirations: Patent cliffs may introduce generics, reducing revenues.
• Competitive Innovation: Emergence of superior or combination therapies may diminish market share.
• Regulatory Hurdles: Delays in approval or withdrawal implications.
• Pricing Pressures: Growing emphasis on cost-effectiveness could lead to reimbursement constraints.

Strategic Outlook

Manufacturers are likely to pursue lifecycle management strategies—such as formulation improvements, new combination regimens, and new indications—to sustain revenue growth. Clinical success of combinations with immunotherapies and targeted personalization will decisively shape the commercial landscape.

---

Key Takeaways

• Expanding Approvals: Lenvatinib’s diversification across tumor types bolsters its market position, with pipeline developments underpinning sustained growth.
• Competitive Edge: Multi-indication approval, oral administration, and combination potential provide strategic advantages amidst a competitive landscape.
• Revenue Growth: Analysts project a trajectory exceeding USD 3 billion annually by 2030, driven by pipeline success, geographical expansion, and strategic partnerships.
• Market Challenges: Patent expiries, pricing pressures, and competition necessitate ongoing innovation and lifecycle management.
• Emerging Opportunities: Clinical advancements in combination therapies and expansion into emerging markets are potent growth levers.

---

FAQs

1. What are the key indications for Lenvatinib mesylate?

Lenvatinib is approved to treat differentiated thyroid cancer refractory to radioactive iodine, unresectable hepatocellular carcinoma, renal cell carcinoma, and endometrial carcinoma—offering a broad oncologic application spectrum[2].

2. How does Lenvatinib compare to other multi-kinase inhibitors?

Lenvatinib demonstrates comparable or superior efficacy in certain indications, notably hepatocellular carcinoma, with a favorable safety profile. Its broader kinase inhibition profile provides differentiated mechanisms, with ongoing combination studies potentially enhancing its clinical utility.

3. What are the primary drivers behind Lenvatinib’s market growth?

Key drivers include expanded indications, combination therapies with immune checkpoint inhibitors, regulatory approvals in multiple regions, and strategic entry into emerging markets.

4. How might patent expirations impact Lenvatinib’s revenues?

Patent expirations could lead to generic competition, exerting downward pressure on prices and revenues. Lifecycle strategies focus on new formulations, indications, or combinations to mitigate these effects.

5. What are the prospects for Lenvatinib in combination therapies?

Clinical trials, such as LEAP-002 combining Lenvatinib with pembrolizumab, show promising efficacy, suggesting that combination regimens will be pivotal in extending its market and financial trajectory.

---

References

1. Grand View Research. Oncology Drugs Market Size, Share & Trends Analysis Report. 2021.
2. U.S. Food and Drug Administration. Lenvatinib (Lenvima) prescribing information. 2015.
3. Kudo M et al. Efficacy of Lenvatinib in Hepatocellular Carcinoma Patients: Real-World Data. Journal of Hepatology. 2020.
4. Kelley RK et al. Lenvatinib Plus Pembrolizumab in Advanced Hepatocellular Carcinoma (LEAP-002): Results From a Phase 3 Trial. The Lancet Oncology. 2022.