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Last Updated: January 18, 2020

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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 five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-two patent family members in thirty-three 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

  Start Trial

Lenvima was eligible for patent challenges on February 13th, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 26th, 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.

Drug patent expirations by year for LENVIMA
Drug Prices for LENVIMA

See drug prices for LENVIMA

Generic Entry Opportunity Date for LENVIMA
Generic Entry Date for LENVIMA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Taipei Veterans General Hospital, TaiwanPhase 1/Phase 2
National Taiwan University HospitalPhase 1/Phase 2
M.D. Anderson Cancer CenterPhase 1

See all LENVIMA clinical trials

Recent Litigation for LENVIMA

Identify potential future generic entrants

District Court Litigation
Case NameDate
EISAI R&D MANAGEMENT CO., LTD. v. SUN PHARMACEUTICAL INDUSTRIES LTD.2019-12-23
EISAI R&D MANAGEMENT CO., LTD. v. SHILPA MEDICARE LIMITED2019-11-08

See all LENVIMA litigation

Pharmacology for LENVIMA
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
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   Start Trial   Start Trial   Start Trial
Eisai Inc LENVIMA lenvatinib mesylate CAPSULE;ORAL 206947-002 Feb 13, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Eisai Inc LENVIMA lenvatinib mesylate CAPSULE;ORAL 206947-001 Feb 13, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Eisai Inc LENVIMA lenvatinib mesylate CAPSULE;ORAL 206947-001 Feb 13, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Eisai Inc LENVIMA lenvatinib mesylate CAPSULE;ORAL 206947-002 Feb 13, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Eisai Inc LENVIMA lenvatinib mesylate CAPSULE;ORAL 206947-002 Feb 13, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for LENVIMA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1415987 C01415987/01 Switzerland   Start Trial PRODUCT NAME: LENVATINIB; REGISTRATION NO/DATE: SWISSMEDIC 65512 19.08.2015
1415987 553 Finland   Start Trial
1415987 15C0070 France   Start Trial 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 92858 Luxembourg   Start Trial PRODUCT NAME: LENVATINIB, OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU UN HYDRATE DE CELUI-CI
1415987 CA 2015 00053 Denmark   Start Trial 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
1698623 C 2015 041 Romania   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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