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Generated: May 22, 2019

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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
Drug patent expirations by year 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.

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

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

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Paragraph IV (Patent) Challenges for LENVIMA
Drugname Dosage Strength RLD Date
➤ Subscribe Capsules 4 mg and 10 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for LENVIMA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1415987 57/2015 Austria ➤ Sign Up 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 ➤ Sign Up PRODUCT NAME: LENVATINIBAS; REGISTRATION NO/DATE: EU/1/15/1002/001 - 002 20150528
1415987 1590053-3 Sweden ➤ Sign Up 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 ➤ Sign Up 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 ➤ Sign Up PRODUCT NAME: LENVATINIB ODER EINES SEINER PHARMAZEUTISCH AKZEPTABLEN SALZE ODER EINES SEINER HYDRATE; REGISTRATION NO/DATE: EU/1/15/1002/001-002 20150528
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Chinese Patent Office
Farmers Insurance
Mallinckrodt
Citi
Deloitte

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