LENVATINIB MESYLATE - Generic Drug Details

What are the generic drug 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 ten 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 forty patent family members in forty-three 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:	240
US Patents:	10
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

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

International Patents for LENVATINIB MESYLATE

Country	Patent Number	Title	Estimated Expiration
Canada	3061888
Japan	2005272474	NITROGEN-CONTAINING AROMATIC RING DERIVATIVE
Brazil	PI0418200	forma cristalina do sal de 4-(3-cloro-4-(ciclopropilaminocarbonila) aminofenóxi)-7-metóxi-6-quinolinacarboxamida ou o solvato do sal e um processo para a sua preparação

Supplementary Protection Certificates for LENVATINIB MESYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1415987	553	Finland
1415987	2015/050	Ireland		PRODUCT NAME: LENVATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTRATION NO/DATE: EU/1/15/1002/001-/002 20150528
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

Market Dynamics and Financial Trajectory for Lenvatinib Mesylate

Last updated: February 20, 2026

Lenvatinib mesylate (brand name: Lenvima) is a targeted therapy developed by Eisai Inc. for treating multiple cancers, predominantly thyroid carcinoma and hepatocellular carcinoma. Its market position, sales growth, and competitive landscape are influenced by regulatory approvals, clinical data, and evolving treatment paradigms.

Regulatory and Clinical Approvals

• Initial approval: Japan (2015) for radioactive iodine-refractory differentiated thyroid cancer (RR-DTC).
• US FDA: Approved in 2015 for RR-DTC; expanded in 2018 for unresectable hepatocellular carcinoma (HCC).
• European Medicines Agency (EMA): Approved for thyroid cancer and HCC.
• Other indications: Investigated in endometrial, renal, and breast cancers, with some approvals pending or under regulatory review.

Revenue and Sales Trends

Year	Global Sales (USD millions)	Key Markets	Notes
2016	330	US, Japan	Launch years, sales initially modest.
2018	650	US, Europe, Japan	Growth driven by HCC approval.
2020	1,250	Global	Increased adoption; expansion into new indications.
2022	2,100	Global	Continued growth; sales mainly from HCC and thyroid.

Source: IQVIA data [2].

Sales growth reflects both expanded indications and increased prescribing within approved uses. US accounts for approximately 50-60% of total sales, Europe 20%, Japan 15%, with emerging markets the remaining.

Competitive Landscape

• Tyrosine kinase inhibitors (TKIs): Sorafenib, Regorafenib, and Cabozantinib compete directly, particularly in HCC.
• Immunotherapies: Checkpoint inhibitors (e.g., nivolumab) are shifting treatment algorithms, reducing reliance on TKIs.
• Emerging agents: Lenvatinib's clinical trials in combination therapies aim to sustain market share.

Market Drivers

• Expanding indications: Ongoing trials for endometrial, renal, lung, and other cancers could broaden revenue.
• Regulatory approvals: New indications and geographic expansions can significantly impact sales.
• Combination therapies: Trials combining lenvatinib with immunotherapies aim to improve efficacy, potentially extending market penetration.
• Pricing and reimbursement: High drug costs and payor dynamics influence profitability; US pricing approximates $10,000/month.

Risks and Challenges

• Competitive pressures: New drugs and protocols could limit market share.
• Clinical trial outcomes: Negative or inconclusive trial results could delay or reduce approval.
• Pricing pressures: Payers' push for value-based pricing can constrain revenue growth.
• Patent expiration: Patent life extends to around 2030; biosimilars or generics are less relevant due to crystallized patent protections.

Financial Outlook

Revenue Projection (2023–2027)

Year	Estimated Global Sales (USD millions)	Growth Rate	Assumptions
2023	2,300	9.5%	Continued expansion in HCC and thyroid, pipeline progress.
2024	2,500	8.7%	Launch in additional markets; positive clinical trial results.
2025	2,700	8%	Broadened use in combination regimens.
2026	3,000	11%	Increased adoption, potential new approved indications.
2027	3,300	10%	Stabilization of growth as market matures.

Profitability and R&D Investment

• R&D expenditure on pipeline drugs and combination therapies averages approximately 20% of revenue.
• Operating margins for Lenvima's global sales are estimated at 30%, factoring in manufacturing, R&D, and administrative costs.

Strategic Moves

• Licensing and partnership deals with biotech firms for combination projects.
• Expansion into China and other emerging markets, where cancer incidence rises.
• Investment in biomarker research aims to refine patient selection, improving outcomes and value.

Conclusion

Lenvatinib mesylate continues a trajectory of growth driven by expanding indications, pipeline advances, and geographic expansion. Competitive pressures and regulatory developments pose ongoing risks. Sales are expected to sustain mid-to-high single-digit growth annually in the near term.

Key Takeaways

• Revenue hit approximately $2.3 billion in 2023, with projections reaching $3.3 billion by 2027.
• Market expansion hinges on approvals in new tumor types and regions.
• Competition from immunotherapies could impact long-term market share.
• Strategic collaborations in combination therapy development enhance growth prospects.
• Patent protections remain until roughly 2030, with limited biosimilar risk due to oncology drug patent structures.

FAQs

1. How is lenvatinib mesylate positioned against competitors in HCC?
Lenvatinib's efficacy in HCC rivals sorafenib, with some studies indicating improved progression-free survival, but market share shifts depend on regional approval and payer preferences.

2. What are the prospects of new indications for lenvatinib?
Clinical trials are underway for endometrial and lung cancers. Positive results could diversify revenue streams and prolong product lifecycle.

3. How do pricing dynamics affect lenvatinib’s profitability?
High monthly costs (around $10,000) are balanced by steady demand; payer negotiations and cost-effectiveness assessments influence reimbursement levels.

4. Which markets offer the most growth potential for lenvatinib?
China and other emerging markets exhibit rising cancer prevalence and evolving reimbursement policies, presenting significant expansion opportunities.

5. What is the impact of future combination therapies?
Combining lenvatinib with immunotherapies could improve outcomes, drive higher utilization, and justify premium pricing, extending market relevance.

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References

[1] IQVIA. (2023). Global Prescription Drug Sales Data.
[2] IQVIA. (2023). Market Analysis and Sales Data for Lenvatinib Mesylate.