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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 eight patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty patent family members in thirty-six 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 three 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:	180
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	54
Patent Applications:	204
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:

10,259,791*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 nine US patents and seven FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,259,791.

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	206947-002	Feb 13, 2015		RX	Yes	Yes
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-002	Feb 13, 2015		RX	Yes	Yes

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

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
Russian Federation	2006126977	КРИСТАЛЛИЧЕСКАЯ ФОРМА СОЛИ 4-(3-ХЛОР-4-(ЦИКЛОПРОПИЛАМИНОКАРБОНИЛ)АМИНОФЕНОКСИ)-7-МЕТОКСИ-6-ХИНОЛИНКАРБОКСАМИДА ИЛИ СОЛЬВАТА ЭТОЙ СОЛИ И СПОСОБЫ ЕЕ ПОЛУЧЕНИЯ
Japan	2018512391	がんを治療するための、ＰＤ−１アンタゴニスト及びＶＥＧＦＲ／ＦＧＦＲ／ＲＥＴチロシンキナーゼ阻害剤の組合せ
Japan	5190361

Supplementary Protection Certificates for LENVIMA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1698623	C 2015 041	Romania		PRODUCT NAME: LENVATINIB; NATIONAL AUTHORISATION NUMBER: DATA NOTIFICARII 01.06.2015 EU/1/15/001, EU/1/15/002; DATE OF NATIONAL AUTHORISATION: 20150528; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): DATA NOTIFICARII 01.06.2015 EU/1/15/001, EU/1/15/002; DATE OF FIRST AUTHORISATION IN EEA: 20150528
1415987	553	Finland
1415987	92858	Luxembourg		PRODUCT NAME: LENVATINIB, OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU UN HYDRATE DE CELUI-CI

LENVIMA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LENVIMA

Introduction to LENVIMA

LENVIMA, also known as lenvatinib, is a tyrosine kinase inhibitor developed by Eisai, a Japanese pharmaceutical company. It has been gaining significant traction in the oncology market, particularly in the treatment of various types of cancer.

Strategic Collaboration with Merck

In March 2018, Eisai entered into a strategic collaboration with Merck & Co., Inc. (known as MSD outside the U.S. and Canada) for the worldwide co-development and co-commercialization of LENVIMA. This partnership has been instrumental in expanding the drug's reach and potential indications. The collaboration includes the development of LENVIMA both as a monotherapy and in combination with Merck's anti-PD-1 therapy, KEYTRUDA (pembrolizumab)[3].

Market Performance and Growth

LENVIMA has shown impressive growth numbers, driven by its expanding indications and strong market presence. In the quarter ending June 30, 2018, LENVIMA generated ¥11,859 million ($106 million) in sales, with more than half of this revenue coming from the U.S. market. The drug's sales in the U.S. increased by 42.8%, largely due to its use in treating kidney and thyroid cancers. Additionally, a significant growth spurt was observed in Japan, where sales increased by 148.5% year over year following the approval for liver cancer treatment in March 2018[1].

Expanding Indications

The drug's label is expected to expand further, with ongoing clinical trials evaluating its efficacy in various cancer types. LENVIMA, in combination with KEYTRUDA, has received the FDA's breakthrough therapy designation for patients with advanced or metastatic kidney cancer. The LEAP (LEnvatinib And Pembrolizumab) clinical program is testing this combination in 11 potential indications across seven cancer types, including endometrial cancer, non-small cell lung cancer, head and neck cancer, bladder cancer, and melanoma[1][3].

Commercial and Marketing Efforts

Merck's involvement has significantly bolstered the commercial and marketing efforts for LENVIMA. In 2018, 100 sales and marketing staff from Merck underwent product training at Eisai to support Eisai’s field force of 150 reps. This collaborative approach has been tailored to meet the specific needs of customers and physicians, as highlighted by Michael Amoroso, then-oncology SVP at Merck[1].

Financial Results

Quarterly and Annual Sales

In the fourth quarter and full year of 2023, LENVIMA contributed notably to Merck's financial performance. The drug generated $960 million in sales for the full year 2023, representing a 10% increase from the previous year. This growth is part of a broader trend in Merck's pharmaceutical segment, which saw an 8% increase in sales driven by oncology, vaccines, and hospital acute care products[2].

Revenue Breakdown

• 2023 Financial Results: LENVIMA sales were $960 million, up 10% from $876 million in 2022[2].
• Regional Performance: Significant revenue was generated from both the U.S. and Japanese markets, with the latter seeing a substantial increase due to new indications[1].

Clinical Trials and Efficacy

Recent clinical trials have further solidified LENVIMA's position in the market. A study published in 2024 showed that LENVIMA plus KEYTRUDA in combination with transarterial chemoembolization (TACE) reduced the risk of disease progression or death by 34% compared to TACE alone in patients with liver cancer. However, this combination also resulted in higher rates of treatment-related adverse events and serious adverse events compared to TACE alone[3].

Market Outlook and Projections

The global lenvatinib market is expected to grow at a compound annual growth rate (CAGR) from 2024 to 2031, driven by increasing demand for targeted cancer therapies and the expansion of LENVIMA's indications. The market report includes detailed analyses of market trends, drivers, opportunities, and restraints, providing a comprehensive outlook for the drug's future performance[4].

Competitive Landscape

LENVIMA operates in a competitive oncology market, but its unique combination with KEYTRUDA and its broad range of potential indications set it apart. The collaboration with Merck has enhanced its competitive edge, allowing for more robust clinical trials and marketing efforts.

Key Takeaways

• Strategic Collaboration: The partnership between Eisai and Merck has been crucial for LENVIMA's success.
• Expanding Indications: Ongoing clinical trials are evaluating LENVIMA in multiple cancer types, including kidney, thyroid, liver, and others.
• Strong Financial Performance: LENVIMA has shown significant revenue growth, contributing to Merck's overall financial success.
• Clinical Efficacy: Recent trials have demonstrated the drug's efficacy, particularly in combination with KEYTRUDA.
• Market Outlook: The global lenvatinib market is projected to grow, driven by increasing demand for targeted cancer therapies.

FAQs

What is LENVIMA used for?

LENVIMA (lenvatinib) is used for the treatment of various types of cancer, including kidney, thyroid, and liver cancers. It is also being evaluated in combination with KEYTRUDA for other cancer types.

Who are the key partners in the development and commercialization of LENVIMA?

Eisai and Merck & Co., Inc. are the key partners in the development and commercialization of LENVIMA.

What is the LEAP clinical program?

The LEAP (LEnvatinib And Pembrolizumab) clinical program is a series of clinical trials evaluating the combination of LENVIMA and KEYTRUDA in various cancer types.

How has LENVIMA performed financially?

LENVIMA has shown significant revenue growth, with $960 million in sales for the full year 2023, representing a 10% increase from the previous year.

What are the potential side effects of LENVIMA in combination with KEYTRUDA?

The combination of LENVIMA and KEYTRUDA has been associated with higher rates of treatment-related adverse events and serious adverse events compared to other treatments.

Sources

1. FiercePharma: "Eisai's Lenvima posts big growth numbers as Merck collaboration rolls into action"
2. Merck: "Merck Announces Fourth-Quarter and Full-Year 2023 Financial Results"
3. Eisai: "LENVIMA® (lenvatinib) Plus KEYTRUDA® (pembrolizumab) in Combination with TACE"
4. Cognitive Market Research: "Lenvatinib Market Report 2024 (Global Edition)"