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Last Updated: July 6, 2020

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LENVIMA Drug Profile


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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 five patents protecting this drug and one Paragraph IV challenge.

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

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

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Drug patent expirations by year for LENVIMA
Drug Prices for LENVIMA

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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
Emory UniversityPhase 2
Washington University School of MedicinePhase 2
Massachusetts Eye and Ear InfirmaryPhase 2

See all LENVIMA clinical trials

Pharmacology for LENVIMA
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 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 206947-001 Feb 13, 2015 RX Yes No   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 553 Finland   Start Trial
1415987 92858 Luxembourg   Start Trial PRODUCT NAME: LENVATINIB, OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU UN HYDRATE DE CELUI-CI
1415987 300764 Netherlands   Start Trial PRODUCT NAME: LENVATINIB, EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1002/001 -002 20150528
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
1698623 261 5023-2015 Slovakia   Start Trial PRODUCT NAME: LENVATINIB MESYLAT; REGISTRATION NO/DATE: EU/1/15/1002/001 - EU/1/15/1002/002 20150601
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Baxter
Harvard Business School
Moodys
AstraZeneca
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.