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LENVIMA Drug Profile

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When do Lenvima patents expire, and when can generic versions of Lenvima launch?

Lenvima is a drug marketed by Eisai Inc and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

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

Summary for LENVIMA

International Patents:	108
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	97
Clinical Trials:	10
Patent Applications:	83
Drug Prices:	Drug price information for LENVIMA
Prior Art and Litigation Support	Order Prior Art and Litigation support for LENVIMA
DailyMed Link:	LENVIMA at DailyMed

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.

Pharmacology for LENVIMA

Drug Class	Kinase Inhibitor
Mechanism of Action	Receptor Tyrosine Kinase Inhibitors

Synonyms for LENVIMA

3J78384F61

4-(3-chloro-4-(3-cyclopropylureido)phenoxy)-7-methoxyquinoline-6-carboxamide

4-(3-Chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinolinecarboxamide

4-(3-chloro-4-(N'-cyclopropylureido)phenoxy)-7-methoxyquinoline-6-carboxamide

4-[3-chloranyl-4-(cyclopropylcarbamoylamino)phenoxy]-7-methoxy-quinoline-6-carboxamide

4-[3-Chloro-4-(cyclopropylaminocarbonyl)aminophenoxy]-7-methoxy-6-quinolinecarboxamide

4-[3-chloro-4-(cyclopropylcarbamoylamino)phenoxy]-7-methoxy-quinoline-6-carboxamide

4-[3-chloro-4-(cyclopropylcarbamoylamino)phenoxy]-7-methoxyquinoline-6-carboxamide

4-[3-chloro-4-[[(cyclopropylamino)-oxomethyl]amino]phenoxy]-7-methoxy-6-quinolinecarboxamide

4-[3-Chloro-4-[[(cyclopropylamino)carbonyl]amino]phenoxy]-7-methoxy-6-quinolinecarboxamide monomethanesulfonate

4-{3-Chloro-4-[(Cyclopropylcarbamoyl)amino]phenoxy}-7-Methoxyquinoline-6-Carboxamide

417716-92-8

4CA-0485

6-carbamoyl-4-{3-chloro-4-[(cyclopropylcarbamoyl)amino]phenoxy}-7-methoxyquinolin-1-ium methanesulfonate

6-Quinolinecarboxamide, 4-(3-chloro-4- (((cyclopropylamino)carbonyl)amino)phenoxy)-7-methoxy-

6-Quinolinecarboxamide, 4-(3-chloro-4-(((cyclopropylamino)carbonyl)amino)phenoxy)- 7-methoxy-, methanesulfonate (1:1)

716C928

857890-39-2

942407-57-0

A1-04306

A825653

ABP000863

AC-25047

AC-30100

AK175809

AK543419

AKOS025401742

AKOS030632716

AN-6642

AOB87766

AS-16203

BC252209

BCP01799

BCP11858

BCP9000633

BCPP000247

BDBM50331094

BRD-K39974922-001-02-7

CHEBI:85994

CHEBI:85995

CHEMBL1289601

CHEMBL2105704

CS-0109

CTK1D4875

D09919

D09920

DB-070219

DB09078

DS-19245

DTXSID50194605

DTXSID90235081

E 7080

E-7080

E7080

E7080 (Lenvatinib)

E7080, E 7080

E7080/E-7080

E7080Mesylate

EE083865G2

ER-203492-00

EX-A249

FT-0700727

GTPL7426

HMS3244A07

HMS3244A08

HMS3244B07

HMS3654A14

HY-10981

J-513372

KB-145996

KB-78118

Kisplyx

KS-00000638

KS-00000TO1

Lenvatinib

Lenvatinib (E7080)

Lenvatinib (USAN/INN)

Lenvatinib [USAN:INN]

Lenvatinib mesilate

Lenvatinib mesilate (JAN)

LENVATINIB MESYLATE

Lenvatinib mesylate (USAN)

Lenvatinib mesylate [USAN]

Lenvatinib; E7080

LenvatinibE7080)

Lenvima (TN)

LEV

methanesulfonic acid--4-{3-chloro-4-[(cyclopropylcarbamoyl)amino]phenoxy}-7-methoxyquinoline-6-carboxamide (1/1)

MLS006011239

MolPort-009-679-469

N-(4-((6-Carbamoyl-7-methoxyquinolin-4-yl)oxy)-2-chlorophenyl)-N'-cyclopropylurea monomethanesulfonate

NCGC00263198-01

NCGC00263198-07

QCR-115

RS0099

s1164

SB16580

SB16581

SC-87813

SCHEMBL864638

SCHEMBL865174

SMR004702999

SW219259-1

SYN1038

UNII-3J78384F61

UNII-EE083865G2

WOSKHXYHFSIKNG-UHFFFAOYSA-N

ZINC3816292

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	206947-001	Feb 13, 2015		RX	Yes	No
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

Paragraph IV (Patent) Challenges for LENVIMA

Drugname	Dosage	Strength	RLD	Date
	Capsules	4 mg and 10 mg

International Patents for LENVIMA

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007136103
Portugal	1415987
South Korea	20060113759
Hong Kong	1102027
South Korea	100839554

Supplementary Protection Certificates for LENVIMA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1698623	PA2015039,C1698623	Lithuania		PRODUCT NAME: LENVATINIBAS; REGISTRATION NO/DATE: EU/1/15/1002/001 - 002 20150528
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	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
1415987	122015000083	Germany		PRODUCT NAME: LENVATINIB ODER EINES SEINER PHARMAZEUTISCH AKZEPTABLEN SALZE ODER EINES SEINER HYDRATE; REGISTRATION NO/DATE: EU/1/15/1002/001-002 20150528