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 ten patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and forty-one patent family members in forty-three 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:	241
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	54
Patent Applications:	1,093
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

Constraining patent/regulatory exclusivity:

10,407,393*PED

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 ten US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,407,393.

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	206947-002	Feb 13, 2015		RX	Yes	Yes
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-001	Feb 13, 2015		RX	Yes	No	7,612,208*PED				Y
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-002	Feb 13, 2015		RX	Yes	Yes	11,090,386*PED				Y
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-002	Feb 13, 2015		RX	Yes	Yes	12,083,112*PED				Y
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-001	Feb 13, 2015		RX	Yes	No	12,226,409*PED				Y
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-001	Feb 13, 2015		RX	Yes	No	11,090,386*PED				Y

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
Norway	339110
Russian Federation	2448708	ПРОТИВООПУХОЛЕВОЕ СРЕДСТВО ПРОТИВ РАКА ЩИТОВИДНОЙ ЖЕЛЕЗЫ (ANTICANCER DRUG FOR THYROID CANCER)
Hungary	E064614
Jordan	P20200225	مشتق كوينولين عالي النقاء وطريقة لإنتاجه (HIGHLY PURE QUINOLINE DERIVATIVE AND METHOD FOR PRODUCING THE SAME)
Japan	WO2011021597
Japan	6659554

Supplementary Protection Certificates for LENVIMA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1415987	15C0070	France		PRODUCT NAME: LENVATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI OU UN HYDRATE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1002 20150601
1415987	553	Finland
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
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	SPC/GB15/063	United Kingdom		PRODUCT NAME: LENVATINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR A HYDRATE THEREOF; REGISTERED: UK EU/1/15/1002/001-002 20150601

Market Dynamics and Financial Trajectory for LENVIMA (lenvatinib)

Last updated: February 19, 2026

LENVIMA (lenvatinib) has established itself as a key player in oncology, with a focus on thyroid cancer, renal cell carcinoma, and hepatocellular carcinoma. Its market growth is driven by expanding indications, competitive positioning, and regulatory approvals. Financial prospects depend on sales performance, patent status, pipeline progress, and competitive landscape.

Market Position and Indications

LENVIMA is developed by Eisai Co., Ltd. and marketed globally by Eisai and Merck KGaA under licensing agreements. Approved indications include:

• Differentiated Thyroid Cancer (DTC): Approved since 2015 in the U.S. and EU.
• Renal Cell Carcinoma (RCC): Approved in combination with pembrolizumab (KEYTRUDA) for advanced RCC from 2019.
• Hepatocellular Carcinoma (HCC): Approved for first-line treatment in unresectable HCC in 2021 (U.S., EU).

Additional indications are under investigation, including endometrial carcinoma and other solid tumors.

Market Size and Growth Drivers

Market Segment	Estimated 2023 Revenue (USD millions)	Growth Rate (CAGR 2023-2028)	Key Drivers
Thyroid Cancer	600	4.5%	Incidence increase, limited existing therapies
Renal Cell Carcinoma	1,000	8.0%	Combination regimens approval, expanded line of therapy
Hepatocellular Carcinoma	800	10.0%	Rising HCC cases globally, safety profile favorable

Total LENVIMA-related sales expected to surpass USD 2.4 billion by 2028, driven by expanded indications and combination therapies.

Competitive Landscape

Competitor	Key Drugs	Market Share (2023)	Notes
Bayer	Nexavar (sorafenib)	15%	Predecessor to LENVIMA in thyroid and RCC indications
Pfizer/AI	Inlyta (axitinib)	8%	Competes in RCC segment, often used in second-line therapy
Novartis	Afinitor (everolimus)	5%	Alternative in certain thyroid cancer cases
Bayer	Cabometyx (cabozantinib)	12%	Competitive in RCC, HCC markets

LENVIMA's combination with pembrolizumab has helped improve its market share, especially in RCC and HCC.

Regulatory and Pipeline Outlook

• Regulatory Filings: LENVIMA received approvals from FDA and EMA with indication extensions, notably in HCC (2021) and thyroid cancer.
• Pipeline: Trials include combinations with immunotherapies and targeted agents for gastric, endometrial, and other solid tumors. Success in these trials could expand revenue streams significantly.
• Patent Status: Patents expire in the U.S. in 2028, with extended exclusivity in some jurisdictions through manufacturing or formulation patents.

Financial Trajectory

Year	Estimated Sales (USD millions)	Growth Rate	Key Assumptions
2022	1,950	7%	Continued expansion in existing markets, pipeline approval gains
2023	2,100	8%	Launch of new indications, increased adoption of combinations
2025	2,500	10%	Pipeline success, market penetration, competition stabilizes
2028	2,450	1.5%	Patent expiration impacts, market saturation, generic entry

Revenue peaks are projected around 2027-2028 with the potential entry of generics in 2028.

Risks and Opportunities

• Risks: Patent expiry, competition from emerging therapies, regulatory delays.
• Opportunities: Broader indication approvals, combination regimens, new therapeutic areas, increased global adoption.

Key Takeaways

• LENVIMA's revenue is expected to grow steadily until patent expiry, with peak sales around 2027-2028.
• The drug benefits from a broadening indication portfolio and alliance-driven combination therapies.
• The competitive landscape is crowded, but LENVIMA’s clinical data and regulatory approvals support growth.
• The pipeline offers potential to sustain or boost sales through new indication approvals.
• Patent expiration risks temper long-term revenue projections but can be mitigated through pipeline innovation and strategic collaborations.

FAQs

1. When does LENVIMA face patent expiration?
Patents in the U.S. expire in 2028, with potential extensions for formulations and manufacturing.

2. What are the main drivers of LENVIMA’s sales growth?
Approved indications in thyroid, RCC, and HCC combined with successful adoption of combination regimens drive revenue growth.

3. How does LENVIMA compare to competitors?
It generally holds a mid-tier market share, benefiting from combination use and broader indications compared to monotherapies like sorafenib and axitinib.

4. What pipeline developments could impact future sales?
Trials for gastric, endometrial, and other solid tumors could expand LENVIMA’s market if successful.

5. How vulnerable is LENVIMA to generic competition?
Patent expiry in 2028 opens the market to generics, which could significantly reduce revenue unless differentiated by new indications or formulations.

References

[1] Eisai Co., Ltd. (2023). LENVIMA product information.
[2] GlobalData. (2023). Oncology market analysis.
[3] FDA. (2021). Approval notices for LENVIMA.
[4] EMA. (2021). Marketing authorization for LENVIMA.

DrugChatter Q&A for LENVIMA

Is lenvima effective for liver cancer?