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.

The generic ingredient in LENVIMA is lenvatinib mesylate. There is one drug master file entry 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 nine 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

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

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

Cyprus

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
Argentina	101695
Australia	2015309862
Brazil	112017002827
Canada	2957005
China	106660964

Supplementary Protection Certificates for LENVIMA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1698623	PA2015039	Lithuania		PRODUCT NAME: LENVATINIBUM; REGISTRATION NO/DATE: EU/1/15/1002/001 - 002 20150528
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	92858	Luxembourg		PRODUCT NAME: LENVATINIB, OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU UN HYDRATE DE CELUI-CI
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

LENVIMA Market Dynamics, Financial Trajectory, Patent Position and Generic Risk

Last updated: August 7, 2026

LENVIMA, the brand name for lenvatinib mesylate, has become one of Eisai’s largest products through expansion from thyroid cancer into renal cell carcinoma, hepatocellular carcinoma and endometrial cancer. Its commercial growth is driven mainly by combination use with Merck’s KEYTRUDA, particularly in advanced renal cell carcinoma and mismatch repair-proficient advanced endometrial carcinoma.

The principal medium-term risks are concentrated U.S. patent expiry for the original small-molecule product, increasing competition in renal and liver cancer, price pressure from generic lenvatinib, and dependence on KEYTRUDA-based regimens. LENVIMA has no biosimilar exposure because it is an orally administered small molecule, but it faces conventional generic-drug risk.

What is LENVIMA and how does it generate revenue?

LENVIMA is an oral kinase inhibitor containing lenvatinib mesylate. It inhibits VEGFR1-3, FGFR1-4, PDGFR-alpha, RET and KIT signaling pathways. Eisai developed and commercializes LENVIMA. Merck, known as MSD outside the United States and Canada, markets KEYTRUDA and shares commercial economics from the combination programs.

Product	Active ingredient	Primary commercial owner	Key role
LENVIMA	Lenvatinib mesylate	Eisai	Oral multikinase inhibitor
KEYTRUDA	Pembrolizumab	Merck	PD-1 antibody used in combination with LENVIMA
LENVIMA plus everolimus	Lenvatinib plus everolimus	Eisai-led regimen	Renal cell carcinoma
LENVIMA plus KEYTRUDA	Lenvatinib plus pembrolizumab	Eisai/Merck alliance	Renal cell carcinoma and endometrial carcinoma

LENVIMA’s revenue model differs from a conventional standalone oncology product. The highest-growth indications require combination therapy, so LENVIMA benefits from Merck’s global KEYTRUDA infrastructure. Merck, in turn, uses LENVIMA to extend KEYTRUDA into settings where PD-1 monotherapy is insufficient.

What are the FDA-approved indications for LENVIMA?

The FDA has approved LENVIMA in four principal disease settings.

FDA approval	Date	Regimen	Commercial relevance
Radioactive iodine-refractory differentiated thyroid cancer	February 2015	LENVIMA monotherapy	Original U.S. indication
Advanced renal cell carcinoma after prior antiangiogenic therapy	May 2016	LENVIMA plus everolimus	Established second-line market
Unresectable hepatocellular carcinoma	August 2018	LENVIMA monotherapy	Major global liver-cancer indication
Advanced endometrial carcinoma after prior systemic therapy	September 2019	LENVIMA plus KEYTRUDA	Major growth driver
Advanced renal cell carcinoma, first line	August 2021	LENVIMA plus KEYTRUDA	High-value expansion into frontline therapy

The endometrial-cancer approval was initially limited to patients whose tumors were not microsatellite instability-high or mismatch repair deficient. The FDA later approved LENVIMA plus KEYTRUDA for advanced endometrial carcinoma after prior systemic therapy, subject to the label’s biomarker and treatment-history requirements.[1]

The frontline renal-cell-carcinoma approval is strategically important because it places LENVIMA in competition with established combinations such as KEYTRUDA plus axitinib, nivolumab plus cabozantinib and nivolumab plus ipilimumab.

How has LENVIMA’s financial trajectory developed?

LENVIMA has shifted from a niche thyroid-cancer product into a major oncology franchise. Eisai’s annual reports show rapid growth after the 2018 HCC approval and the 2019 endometrial-cancer approval, followed by further expansion after the 2021 renal-cell-carcinoma approval.[2]

Revenue growth drivers

The main drivers have been:

1. Expansion of the KEYTRUDA combination into additional geographies.
2. First-line renal-cell-carcinoma penetration.
3. Growth in hepatocellular carcinoma, particularly outside the United States.
4. Continued use in radioactive iodine-refractory thyroid cancer.
5. Increasing physician familiarity with LENVIMA-based combination regimens.

Eisai has described LENVIMA as one of its principal growth products and has repeatedly increased medium-term revenue expectations for the franchise. The product’s contribution is material to Eisai’s overall earnings profile, although the company does not report all alliance economics in a format that directly equals global end-product sales.

Period	Financial direction	Principal factor
2015-2017	Early commercial buildout	Thyroid cancer and second-line RCC
2018-2020	Accelerating growth	HCC approval and KEYTRUDA alliance
2021-2022	Strong expansion	First-line RCC approval
2023-2024	Large-franchise phase	Combination adoption and geographic expansion
2025 onward	Growth with rising exposure to expiry	Continued uptake offset by generic and competitive risk

The KEYTRUDA collaboration also affects reported economics. Eisai and Merck entered into a strategic collaboration in 2018 to develop and commercialize LENVIMA plus KEYTRUDA across multiple cancers. The companies share development costs, gross profits and certain regional commercial responsibilities under the agreement.[3]

What is the commercial impact of the Eisai-Merck licensing deal?

The 2018 Eisai-Merck agreement is one of the most important commercial transactions associated with LENVIMA.

The agreement covers the combination of LENVIMA and KEYTRUDA in multiple oncology indications. It gave LENVIMA access to Merck’s global oncology sales force and KEYTRUDA’s established prescriber base. It also reduced the commercial burden on Eisai for a combination product that depends on an expensive biologic partner.

The deal has three strategic consequences:

• LENVIMA gains access to KEYTRUDA-led treatment algorithms.
• Merck extends KEYTRUDA into additional tumor types and treatment lines.
• Eisai shares development and commercialization economics rather than retaining all upside and cost exposure independently.

The arrangement also creates dependence. LENVIMA’s growth is linked to KEYTRUDA’s continued position in renal and endometrial cancer. Any erosion of KEYTRUDA, changes in treatment guidelines, or competing immunotherapy combinations could reduce LENVIMA demand.

When does LENVIMA lose market exclusivity?

LENVIMA’s loss-of-exclusivity analysis depends on the specific patent, dosage form, indication and jurisdiction. The original U.S. chemical and product protection is approaching or entering the late-life period, while later patents may cover formulations, dosing regimens and combination uses.

The relevant exclusivity layers are:

Exclusivity layer	Commercial effect
New chemical entity exclusivity	Delayed certain ANDA approvals after initial FDA approval
Orphan-drug exclusivity	Protects the approved orphan indication for seven years
Patent protection	Can delay or prevent generic approval and launch
Pediatric exclusivity	May add six months if awarded
Method-of-use patents	Can restrict labeled uses while allowing some carve-out launches
Formulation and crystalline-form patents	May delay substitution if claims survive challenge

LENVIMA is a small molecule, so it does not receive the 12-year reference-product exclusivity applicable to biologics. Generic manufacturers can pursue abbreviated new drug applications once the relevant exclusivity and patent barriers permit approval.

The most important commercial date is therefore not a single expiration date. It is the earliest date on which a generic can obtain FDA approval and lawfully launch a commercially viable product after accounting for listed patents, Paragraph IV litigation, pediatric extensions and any settlement terms.

What patents protect LENVIMA?

LENVIMA’s patent estate includes several categories of protection:

Composition and core molecule patents

The earliest patents cover lenvatinib and related quinoline derivatives. These patents provide the foundational protection for the active pharmaceutical ingredient and generally have the earliest expiration dates.

Salt, crystal and pharmaceutical composition patents

Later patents may cover lenvatinib mesylate, specific crystalline forms, pharmaceutical compositions and capsule formulations. These patents are commercially important because a generic applicant must address the protected form used in the reference product.

Method-of-use patents

Method patents cover treatment of specific cancers, dosing schedules and combinations. Examples include use in:

• Radioactive iodine-refractory thyroid cancer.
• Renal cell carcinoma with everolimus.
• Hepatocellular carcinoma.
• Endometrial carcinoma with pembrolizumab.
• Frontline renal-cell-carcinoma combinations.

Method-of-use claims are less effective against a generic that launches with a valid skinny label excluding patented indications. Their practical value depends on prescribing behavior, product labeling and whether the patented use drives most of the market.

Combination patents

LENVIMA plus KEYTRUDA patents may protect the combination, treatment sequence or patient population. These rights can extend beyond the core lenvatinib compound patents, but they do not necessarily prevent a generic from entering for unprotected monotherapy indications.

The FDA Orange Book is the controlling public source for patents listed against approved LENVIMA products. Patent listings can change as new patents issue, patents expire or regulatory submissions are updated.[4]

How strong is the LENVIMA patent estate?

LENVIMA has a layered but increasingly fragmented estate.

The core molecule protection is weaker late in the product life cycle because it is older and closer to expiry. Later formulation and method-of-use patents can extend commercial protection, but they face several limitations:

• Method-of-use claims may be avoided through a skinny label.
• Combination patents may not block monotherapy entry.
• Narrow formulation claims may be vulnerable to non-infringing alternative formulations.
• Patent term adjustment and patent-term extension may differ by patent.
• A generic can challenge listed patents through Paragraph IV certification.

The estate is stronger commercially in combination indications than in the original thyroid-cancer indication because the KEYTRUDA and everolimus regimens create additional prescribing and patent layers. It is weaker if generic manufacturers initially target only unprotected monotherapy uses.

Which companies are challenging LENVIMA exclusivity?

Potential challengers are likely to include large generic manufacturers with oncology capsule capabilities, such as Teva, Viatris, Sun Pharmaceutical, Dr. Reddy’s Laboratories, Zydus and other ANDA sponsors. The existence of an ANDA filing does not establish a launch date or a successful patent challenge.

A Paragraph IV certification asserts that a listed patent is invalid, unenforceable or not infringed. If the patent owner files an infringement action within 45 days, FDA approval of the ANDA may be stayed for up to 30 months, subject to statutory exceptions and litigation outcomes.[5]

Publicly reported LENVIMA patent litigation and settlement terms should be evaluated case by case. A settlement may provide an authorized-generic launch date, a license date, or restrictions tied to specific indications. No settlement should be treated as a full franchise-wide barrier unless it covers the relevant product, strength, indication and launch territory.

What is the Orange Book status of LENVIMA?

LENVIMA is an FDA-approved prescription drug listed in the Orange Book. The relevant products are oral capsules in multiple strengths, including 4 mg, 8 mg, 10 mg and 14 mg daily-dose configurations depending on the approved presentation.

Orange Book analysis should distinguish:

• Product patents listed against each approved strength.
• Patents covering the active ingredient or formulation.
• Use codes for oncology indications.
• Regulatory exclusivity dates.
• Patent expiration and pediatric-extension dates.
• Whether a listed patent is subject to an active Paragraph IV dispute.

The Orange Book does not determine whether a patent will survive litigation. It identifies the patents that an ANDA applicant must address.

What generic entry risks exist for LENVIMA?

Generic entry is likely to occur in stages rather than through an immediate collapse in all LENVIMA sales.

Scenario 1: Narrow monotherapy entry

A generic launches with a label excluding certain patented uses. This could affect thyroid cancer and other non-protected indications while leaving some combination use commercially insulated.

Scenario 2: Authorized generic or settlement entry

Eisai permits a generic launch before complete patent expiry. This reduces litigation risk but can accelerate price erosion.

Scenario 3: Broad generic launch after patent expiry

A generic enters across the principal capsule presentations. Pharmacy substitution and payer formulary pressure then create rapid erosion in monotherapy and some off-label use.

Scenario 4: Combination-led resilience

LENVIMA retains a substantial share in KEYTRUDA combinations because of clinical familiarity, contracting, supply reliability and physician preference. This would slow but not eliminate erosion.

The highest-risk revenue is likely the portion linked to mature monotherapy uses. Combination revenue has greater clinical and commercial barriers, but those barriers do not prevent generic lenvatinib from being used in combination once substitution becomes accepted.

How does LENVIMA compare with competing cancer drugs?

Market	LENVIMA regimen	Main competitors	Competitive issue
Renal cell carcinoma	LENVIMA plus KEYTRUDA; LENVIMA plus everolimus	KEYTRUDA plus axitinib, nivolumab plus cabozantinib, nivolumab plus ipilimumab	Multiple guideline-supported combinations
Hepatocellular carcinoma	LENVIMA monotherapy	Atezolizumab plus bevacizumab, durvalumab plus tremelimumab, sorafenib	Immunotherapy combinations have reshaped first-line treatment
Endometrial carcinoma	LENVIMA plus KEYTRUDA	Pembrolizumab plus chemotherapy, dostarlimab-based regimens, other immunotherapy combinations	Biomarker segmentation and toxicity management
Thyroid cancer	LENVIMA monotherapy	Sorafenib, cabozantinib	Earlier-line sequencing and tolerability

LENVIMA’s efficacy is offset by a significant adverse-event burden, including hypertension, proteinuria, fatigue, diarrhea, appetite loss, hypothyroidism and dose reductions. Competitors with better tolerability or simpler administration can gain share even before generic entry.

What FDA and regulatory risks affect LENVIMA?

The principal regulatory risk is indication-specific. FDA approvals depend on clinical benefit, safety and the defined patient population. Any future label restriction, safety signal or unfavorable comparative data could affect revenue.

Combination approvals also carry operational complexity. The commercial success of LENVIMA plus KEYTRUDA depends on:

• Companion diagnostic and biomarker requirements.
• Payer coverage of two high-cost products.
• Management of overlapping adverse events.
• Treatment sequencing after prior immunotherapy.
• Regional reimbursement decisions.

The regulatory profile is more durable than a single-indication oncology product because LENVIMA has several approved uses. Its risk is spread across indications, but the largest growth opportunities also depend on competitive treatment algorithms.

What geographic markets drive LENVIMA sales?

LENVIMA has global commercial exposure, with the United States, Japan, Europe and China among the most important markets. Geographic performance differs because of approval timing, reimbursement, local competition and generic-drug policy.

• The United States provides high revenue per patient and strong KEYTRUDA commercialization.
• Japan is strategically important to Eisai and benefits from the company’s local infrastructure.
• Europe is fragmented by national reimbursement and health-technology assessment.
• China offers significant patient volume but greater pricing and procurement pressure.
• Emerging markets provide volume potential but lower net pricing.

Patent expiry also occurs by jurisdiction. A launch in one market does not establish legal availability elsewhere.

What manufacturing and intellectual-property barriers protect LENVIMA?

LENVIMA is an oral small molecule, so its manufacturing barriers are lower than those for a biologic. Generic manufacturers do not need to replicate a cell-line process or demonstrate biosimilarity. They must establish pharmaceutical equivalence, bioequivalence and adequate manufacturing controls.

Potential barriers include:

• Synthesis and purification of lenvatinib mesylate.
• Control of polymorphic or crystalline forms.
• Capsule content uniformity at multiple strengths.
• Stability and dissolution specifications.
• Regulatory approval for each strength and presentation.
• Supply-chain qualification for oncology distribution.

These barriers can delay entry, but they are unlikely to provide durable protection comparable to biologic manufacturing complexity.

What revenue exposure does Eisai face from LENVIMA?

LENVIMA is a major concentration risk for Eisai. The product’s growth has helped offset maturity in other parts of the company’s portfolio and supports Eisai’s oncology strategy. A substantial generic price decline would affect:

• Product revenue.
• Alliance economics with Merck.
• Eisai’s oncology operating margin.
• Valuation assumptions based on continued LENVIMA growth.
• Funding capacity for new oncology programs.

The exposure is moderated by Eisai’s broader portfolio, including LEQEMBI and other neurology and oncology products. It remains material because LENVIMA is one of the company’s principal commercial assets.

Key Takeaways

• LENVIMA is an Eisai oncology franchise built around lenvatinib mesylate.
• Its largest growth engine is combination use with Merck’s KEYTRUDA.
• The product has FDA approvals in thyroid cancer, renal cell carcinoma, hepatocellular carcinoma and endometrial carcinoma.
• Revenue growth accelerated after the HCC and KEYTRUDA combination approvals.
• LENVIMA has no biosimilar risk, but it has conventional generic-drug exposure.
• Core composition protection is approaching the late-life period, while formulation, combination and method-of-use patents may provide narrower later protection.
• Generic entry could occur first in unprotected monotherapy indications and later affect combination use.
• Competition is strongest in renal cell carcinoma and hepatocellular carcinoma.
• The Eisai-Merck alliance increases commercial reach but links LENVIMA performance to KEYTRUDA’s market position.
• The Orange Book, patent litigation records and any Paragraph IV settlements remain the decisive sources for launch timing.

FAQs

Does LENVIMA have biosimilar competition?

No. LENVIMA is a small-molecule oral drug, so any future competitor would normally be an FDA-approved generic lenvatinib product rather than a biosimilar.

Can a generic lenvatinib launch for only one cancer indication?

Yes. An ANDA applicant may use a skinny label that excludes patented methods of use, although prescribing practices and induced-infringement disputes can affect the practical scope of such a launch.

Is LENVIMA more exposed to generic entry than KEYTRUDA?

Yes. LENVIMA is a small molecule with conventional ANDA exposure. KEYTRUDA is a biologic and faces a biosimilar pathway with different regulatory, manufacturing and interchangeability requirements.

Which LENVIMA indication has the strongest long-term commercial protection?

The KEYTRUDA combination indications have the most layered commercial protection because they rely on combination patents, clinical adoption and treatment algorithms. They are not immune from generic entry once lenvatinib becomes available.

Why does LENVIMA remain commercially important despite competing immunotherapies?

It has activity across several tumor types, a broad global label, established physician familiarity and a commercially important partnership with KEYTRUDA. Its durability depends on maintaining clinical utility despite competition and managing its toxicity profile.

References

1. U.S. Food and Drug Administration. (2015-2021). LENVIMA (lenvatinib mesylate) prescribing information and approval history. https://www.accessdata.fda.gov
2. Eisai Co., Ltd. (2024). Annual report and financial results. https://www.eisai.com
3. Merck & Co., Inc. (2018-2024). Annual reports and KEYTRUDA-LENVIMA collaboration disclosures. https://www.merck.com
4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/
5. U.S. Food and Drug Administration. (2024). Hatch-Waxman amendments and abbreviated new drug applications. https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/generic-drug-user-fee-amendmentsgrace period

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