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Last Updated: January 22, 2021

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Lenvatinib mesylate - Generic Drug Details

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What are the generic sources for lenvatinib mesylate and what is the scope of patent protection?

Lenvatinib mesylate is the generic ingredient in one branded drug marketed by Eisai Inc and is included in one NDA. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lenvatinib mesylate has one hundred and twenty-five patent family members in thirty-four countries.

There are four drug master file entries for lenvatinib mesylate. One supplier is listed for this compound.

Recent Clinical Trials for lenvatinib mesylate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Shanghai Zhongshan HospitalPhase 2
Shanghai Jiahui International HospitalPhase 2
Merck Sharp & Dohme Corp.Phase 2

See all lenvatinib mesylate clinical trials

Pharmacology for lenvatinib mesylate
Paragraph IV (Patent) Challenges for LENVATINIB MESYLATE
Tradename Dosage Ingredient NDA Submissiondate
LENVIMA CAPSULE;ORAL lenvatinib mesylate 206947 2019-02-13

US Patents and Regulatory Information for lenvatinib mesylate

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 206947-002 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
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   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 Y Y   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 lenvatinib mesylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1415987 2015/050 Ireland   Start Trial PRODUCT NAME: LENVATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTRATION NO/DATE: EU/1/15/1002/001-/002 20150528
1415987 1590053-3 Sweden   Start Trial PRODUCT NAME: LENVATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REG. NO/DATE: EU/1/15/1002 20150601
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 553 Finland   Start Trial
1698623 PA2015039,C1698623 Lithuania   Start Trial PRODUCT NAME: LENVATINIBAS; REGISTRATION NO/DATE: EU/1/15/1002/001 - 002 20150528
1415987 92858 Luxembourg   Start Trial PRODUCT NAME: LENVATINIB, OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU UN HYDRATE DE CELUI-CI
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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