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 six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty-three patent family members in thirty-five 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 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:	133
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	140
Clinical Trials:	41
Patent Applications:	404
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 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
Elizabeth K. Lee MD	Phase 2
AstraZeneca	Phase 3
National University Hospital, Singapore	Phase 2

See all LENVIMA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for LENVIMA

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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 six US patents and six FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting LENVIMA

FDA Regulatory Exclusivity protecting 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			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
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

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

European Patent Office

Israel

Japan

Jordan

Mexico

Russian Federation

Singapore

South Korea

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
Singapore	11201700855X	HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME
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	6659554
Singapore	10202100272R	HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME
South Korea	20170043516	고순도의 퀴놀린 유도체 및 이를 제조하는 방법 (HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME)
South Korea	20030040552

Supplementary Protection Certificates for LENVIMA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1415987	92858	Luxembourg		PRODUCT NAME: LENVATINIB, OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU UN HYDRATE DE CELUI-CI
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
1415987	132016000024218	Italy		PRODUCT NAME: LENVATINIB O UN SUO SALE ACCETTABILE FARMACEUTICAMENTE O SUO IDRATO(LENVIMA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1002/001-002, 20150601
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
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