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 one hundred and ninety-seven 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:	197
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:	13
Patent Applications:	645
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
Henan Cancer Hospital	Phase 2
Shanghai Junshi Bioscience Co., Ltd.	Phase 3
RenJi Hospital	N/A

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
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-001	Feb 13, 2015		RX	Yes	No					Y
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-001	Feb 13, 2015		RX	Yes	No					Y
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
China	113683564	高纯度喹啉衍生物及其生产方法 (HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME)
Japan	3712393
Hong Kong	1102027	CRYSTAL (C) OF MESYLATE OF 4-(3-CHLORO-4-(CYCLOPROPYLAMINOCARBONYL)AMINO- PHENOXY)-7-METHOXY-6-QUINOLINECARBOXAMIDE AND PROCESSES FOR PRODUCING THESE
Japan	2016196411	腫瘍治療剤 (TUMOR THERAPEUTIC AGENT)

Supplementary Protection Certificates for lenvatinib mesylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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	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 of Lenvatinib Mesylate

Introduction to Lenvatinib Mesylate

Lenvatinib mesylate, marketed as Lenvima, is an oral tyrosine kinase inhibitor (TKI) developed by Eisai Co. Ltd. and commercialized in collaboration with Merck. This drug has been gaining significant traction in the oncology market due to its efficacy in treating various types of cancer, including thyroid cancer, hepatocellular carcinoma, and renal cell carcinoma.

Market Growth and Projections

The market for lenvatinib mesylate is experiencing robust growth, driven by several key factors:

• Increasing Incidence of Cancer: The global rise in cancer cases, particularly thyroid and liver cancers, has increased the demand for effective therapeutic solutions like lenvatinib mesylate. This trend is expected to continue, with the market anticipated to grow at a compound annual growth rate (CAGR) of 8.46% from 2024 to 2031[4].
• Therapeutic Efficacy: Lenvatinib's ability to target multiple pathways involved in tumor growth makes it a preferred choice among oncologists. Clinical trials and studies have shown promising results, especially when used in combination with other treatments like pembrolizumab (Keytruda)[2].

Market Segmentation

The lenvatinib mesylate market is segmented based on several criteria:

• Type: The market is categorized into purity levels, such as purity ≥99% and purity <99%[1].
• Application: The drug is used in various forms, including capsules and other formulations[1].
• Geographical Regions: The market is analyzed across North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its unique market dynamics, with North America and Europe being significant contributors due to their robust economies and advanced healthcare infrastructure[4].

Collaborations and Partnerships

The collaboration between Eisai and Merck is a pivotal factor in the market dynamics of lenvatinib mesylate:

• Development and Commercialization: Under the agreement, Eisai books product sales globally, while both companies share gross profits equally. Merck pays Eisai significant upfront and milestone payments, reflecting the high potential of the drug[2].
• Clinical Trials and Approvals: The combination of lenvatinib with pembrolizumab has received Breakthrough Therapy designation from the US FDA for the treatment of renal cell carcinoma, further boosting market confidence[2].

Financial Trajectory

The financial outlook for lenvatinib mesylate is promising:

• Revenue Projections: The market is expected to transition from a valuation of USD 11.09 billion in 2024 to USD 19.58 billion by 2031, indicating a substantial increase in revenue[4].
• Milestone Payments: Eisai is eligible to receive significant milestone payments from Merck, including up to $3.97 billion if certain sales benchmarks are achieved[2].
• Profit Sharing: The equal sharing of gross profits between Eisai and Merck ensures that both companies benefit from the drug's commercial success[2].

Drivers and Restraints

Drivers

• Increasing Demand for Targeted Therapies: The rising use of targeted therapies in cancer treatment has increased demand for lenvatinib mesylate[4].
• Regulatory Approvals: Favorable regulatory approvals and guidelines support the use of lenvatinib in various cancer treatments, enhancing market growth[4].
• Research and Development: Ongoing research and clinical trials exploring the drug's applicability in different forms of cancer continue to drive market expansion[4].

Restraints

• High Development Costs: The costs associated with clinical trials and research can be a significant restraint, although collaborations like the one between Eisai and Merck help mitigate these costs[2].
• Market Competition: The oncology market is highly competitive, with other TKIs and cancer treatments vying for market share[3].

Geographical Market Analysis

North America

• This region is a significant player in the global lenvatinib mesylate market, driven by a robust economy, technological advancements, and a strong consumer base with high purchasing power[4].

Europe

• Europe is characterized by a mature market with well-established infrastructure and consumer preferences. Countries like the UK, Germany, France, and Italy are major contributors[4].

Asia-Pacific

• This region is rapidly growing, driven by countries such as China, Japan, India, and South Korea. The large population, rising disposable income, and increasing urbanization are key factors[4].

Latin America and Middle East & Africa

• These regions present opportunities and challenges, with economic fluctuations and political instability in some countries impacting market dynamics. However, countries like Brazil, Mexico, and South Africa show promising growth potential[4].

Competitive Scenario

The lenvatinib mesylate market is characterized by a competitive landscape with several key players:

• Eisai and Merck: The collaboration between these two companies is a dominant force in the market, with both companies investing heavily in research and development[2].
• Other Players: Companies like Sun Pharm Inds Inc, Lepu Pharmaceuticals, Qilu Pharmaceutical, and Yangtze River Pharmaceutical Group are also significant players, contributing to the market's competitive dynamics[4].

Regulatory and Clinical Milestones

• Breakthrough Therapy Designation: The combination of lenvatinib with pembrolizumab has received Breakthrough Therapy designation from the US FDA for renal cell carcinoma, highlighting the drug's potential[2].
• Clinical Trials: Ongoing and completed clinical trials have shown promising results, such as the phase Ib/II Study 111/KEYNOTE-146 trial, which demonstrated an objective response rate (ORR) of 83% in treatment-naïve patients[2].

Key Takeaways

• The lenvatinib mesylate market is poised for significant growth driven by increasing cancer incidence, therapeutic efficacy, and favorable regulatory approvals.
• The collaboration between Eisai and Merck is crucial for the drug's commercial success.
• The market is segmented by type, application, and geographical regions, each with unique dynamics.
• North America and Europe are major contributors, while Asia-Pacific is a rapidly growing region.
• The financial trajectory indicates substantial revenue growth and significant milestone payments.

FAQs

What is the expected CAGR of the lenvatinib mesylate market from 2024 to 2031?

The lenvatinib mesylate market is anticipated to witness a CAGR of 8.46% from 2024 to 2031[4].

Which companies are involved in the development and commercialization of lenvatinib mesylate?

Eisai Co. Ltd. and Merck are the primary companies involved in the development and commercialization of lenvatinib mesylate[2].

What is the significance of the Breakthrough Therapy designation for lenvatinib mesylate?

The Breakthrough Therapy designation for the combination of lenvatinib with pembrolizumab for renal cell carcinoma highlights the drug's potential and accelerates its development and review process[2].

Which regions are the major contributors to the global lenvatinib mesylate market?

North America, Europe, and Asia-Pacific are the major contributors to the global lenvatinib mesylate market[4].

What are the key drivers of the lenvatinib mesylate market?

The key drivers include increasing demand for targeted therapies, favorable regulatory approvals, and ongoing research and development in various cancer treatments[4].

Sources

1. Market Research Intellect: Global Lenvatinib Mesylate Market Size, Trends and Projections[1].
2. OncLive: Eisai And Merck to Collaborate on Lenvatinib Mesylate[2].
3. The Business Research Company: Global Thyroid Cancer Drugs Market Report 2024[3].
4. OpenPR: Lenvatinib Mesylate Capsules Market Size, Share and Forecast[4].
5. Synapse: Lenvatinib mesylate - Drug Targets, Indications, Patents[5].

Last updated: 2024-12-16