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LENVIMA Drug Profile

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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 five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-four patent family members in thirty-four 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.

US ANDA Litigation and 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 August 26, 2035. This may change due to patent challenges or generic licensing.

There have been two 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.

Indicators of Generic Entry

Summary for LENVIMA

International Patents:	124
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	116
Clinical Trials:	15
Patent Applications:	99
Drug Prices:	Drug price information for LENVIMA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LENVIMA
DailyMed Link:	LENVIMA at DailyMed

See drug prices for LENVIMA

Generic Entry Opportunity Date for LENVIMA

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
Emory University	Phase 2
Washington University School of Medicine	Phase 2
Massachusetts Eye and Ear Infirmary	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	NDA	Submissiondate
LENVIMA	CAPSULE;ORAL	lenvatinib mesylate	206947	2019-02-13

US Patents and Regulatory Information for LENVIMA

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	206947-001	Feb 13, 2015		RX	Yes	No
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
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-001	Feb 13, 2015		RX	Yes	No			Y	Y
Eisai Inc	LENVIMA	lenvatinib mesylate	CAPSULE;ORAL	206947-002	Feb 13, 2015		RX	Yes	Yes			Y	Y
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

International Patents for LENVIMA

Country	Patent Number	Estimated Expiration
Russian Federation	2448708
Hungary	230302
Canada	2543650
Russian Federation	2017104496
Germany	60134679
Montenegro	02184
Japan	WO2002032872

Supplementary Protection Certificates for LENVIMA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1415987	553	Finland
1415987	92858	Luxembourg		PRODUCT NAME: LENVATINIB, OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU UN HYDRATE DE CELUI-CI
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
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	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
1698623	261 5023-2015	Slovakia		PRODUCT NAME: LENVATINIB MESYLAT; REGISTRATION NO/DATE: EU/1/15/1002/001 - EU/1/15/1002/002 20150601
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