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Last Updated: March 19, 2024

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LENVIMA Drug Patent 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 seven patents protecting this drug and one Paragraph IV challenge.

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

DrugPatentWatch® 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 three 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

See drug prices for LENVIMA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
University of California, San FranciscoPhase 2
Adenoid Cystic Carcinoma Research FoundationPhase 1/Phase 2
Glenn J. HannaPhase 1/Phase 2

See all LENVIMA clinical trials

Pharmacology for LENVIMA
Paragraph IV (Patent) Challenges for LENVIMA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LENVIMA Capsules lenvatinib mesylate 4 mg and 10 mg 206947 2 2019-02-13

US Patents and Regulatory Information for LENVIMA

LENVIMA is protected by seven US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of LENVIMA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting LENVIMA

High-purity quinoline derivative and method for manufacturing same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

High-purity quinoline derivative and method for manufacturing same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT WITH LENVIMA BY ADMINISTERING LENVIMA AS A SUSPENSION

High-purity quinoline derivative and method for manufacturing same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Nitrogen-containing aromatic derivatives
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Crystalline form of the salt of 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinoli- necarboxamide or the solvate of the salt and a process for preparing the same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Antitumor agent for thyroid cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD FOR TREATING THYROID CARCINOMA INCLUDING DIFFERENTIATED THYROID CANCER

FDA Regulatory Exclusivity protecting LENVIMA

INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC)
Exclusivity Expiration: ⤷  Try a Trial

REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY 309/KEYNOTE-775 TO SUPPORT PMR 3696-1 AND 3700-1
Exclusivity Expiration: ⤷  Try a Trial

LENVATINIB IN COMBINATION WITH PEMBROLIZUMAB, IS INDICATED FOR THE FIRST-LINE TREATMENT OF ADULT PATIENTS WITH ADVANCED RENAL CELL CARCINOMA (RCC)
Exclusivity Expiration: ⤷  Try a Trial

REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY E7080-G000-211 TO SUPPORT PMR 2865-1
Exclusivity Expiration: ⤷  Try a Trial

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

International Patents for LENVIMA

When does loss-of-exclusivity occur for LENVIMA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 1695
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 15309862
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2017002827
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 57005
Estimated Expiration: ⤷  Try a Trial

China

Patent: 6660964
Estimated Expiration: ⤷  Try a Trial

Patent: 3683564
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0221047
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 24595
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 87491
Estimated Expiration: ⤷  Try a Trial

Patent: 24595
Estimated Expiration: ⤷  Try a Trial

Patent: 25305
Estimated Expiration: ⤷  Try a Trial

Patent: 89076
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 59606
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 0454
Estimated Expiration: ⤷  Try a Trial

Patent: 2218
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 2016031841
Estimated Expiration: ⤷  Try a Trial

Patent: 59554
Estimated Expiration: ⤷  Try a Trial

Jordan

Patent: 0200225
Estimated Expiration: ⤷  Try a Trial

Patent: 83
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 24595
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 17001980
Estimated Expiration: ⤷  Try a Trial

Patent: 22009299
Estimated Expiration: ⤷  Try a Trial

Patent: 22009300
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 24595
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 24595
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 17104496
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 559
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 202100272R
Estimated Expiration: ⤷  Try a Trial

Patent: 201700855X
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 24595
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2329681
Estimated Expiration: ⤷  Try a Trial

Patent: 2512940
Estimated Expiration: ⤷  Try a Trial

Patent: 170043516
Estimated Expiration: ⤷  Try a Trial

Patent: 210144916
Estimated Expiration: ⤷  Try a Trial

Patent: 230043234
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 26687
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 21954
Estimated Expiration: ⤷  Try a Trial

Patent: 1625544
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LENVIMA around the world.

Country Patent Number Title Estimated Expiration
South Korea 100589032 ⤷  Try a Trial
Canada 2976325 PROCEDE DE SUPPRESSION DE L'AMERTUME D'UN DERIVE DE QUINOLEINE (METHOD FOR SUPPRESSING BITTERNESS OF QUINOLINE DERIVATIVE) ⤷  Try a Trial
Norway 2015021 ⤷  Try a Trial
Croatia P20150694 ⤷  Try a Trial
South Korea 20080028511 A CRYSTALLINE FORM OF THE SALT OF 4-(3-CHLORO-4-(CYCLOPROPYLAMINOCARBONYL)AMINOPHENOXY)-7-METHOXY-6-QUINOLINECARBOXAMIDE OR THE SOLVATE OF THE SALT AND A PROCESS FOR PREPARING THE SAME ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LENVIMA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1415987 2015/050 Ireland ⤷  Try a 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 PA2015039,C1698623 Lithuania ⤷  Try a Trial PRODUCT NAME: LENVATINIBAS; REGISTRATION NO/DATE: EU/1/15/1002/001 - 002 20150528
1415987 122015000083 Germany ⤷  Try a Trial PRODUCT NAME: LENVATINIB ODER EINES SEINER PHARMAZEUTISCH AKZEPTABLEN SALZE ODER EINES SEINER HYDRATE; REGISTRATION NO/DATE: EU/1/15/1002/001-002 20150528
1698623 261 5023-2015 Slovakia ⤷  Try a Trial PRODUCT NAME: LENVATINIB MESYLAT; REGISTRATION NO/DATE: EU/1/15/1002/001 - EU/1/15/1002/002 20150601
1698623 PA2015039 Lithuania ⤷  Try a Trial PRODUCT NAME: LENVATINIBUM; 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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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.