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Last Updated: November 28, 2024

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lenvima Drug Patent Profile


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When do Lenvima patents expire, and what generic alternatives are available?

Lenvima is a drug marketed by Eisai Inc and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty patent family members in thirty-six 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 February 26, 2036. 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.

There is one tentative approval for the generic drug (lenvatinib mesylate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for lenvima
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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 Medical Center GroningenPhase 4
Tongji HospitalPhase 3
University of California, San FranciscoPhase 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 nine US patents and seven FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of lenvima is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

High-purity quinoline derivative and method for manufacturing same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

High-purity quinoline derivative and method for manufacturing same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FIRST-LINE TREATMENT OF ADULTS PATIENTS WITH ADVANCED RENAL CELL CARCINOMA BY ADMINISTERING LENVIMA IN COMBINATION WITH PEMBROLIZUMAB


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF PATIENTS WITH PMMR/NOT MSI-H ADVANCED ENDOMETRIAL CARCINOMA, HAVE DISEASE PROGRESSION FOLLOWING PRIOR SYSTEMIC THERAPY, AND ARE NOT CANDIDATES FOR CURATIVE SURGERY OR RADIATION, BY ADMINISTERING LENVIMA IN COMBINATION WITH PEMBROLIZUMAB

Nitrogen-containing aromatic derivatives
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Antitumor agent for thyroid cancer
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting lenvima

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

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

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

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

ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  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 206947-002 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
Eisai Inc LENVIMA lenvatinib mesylate CAPSULE;ORAL 206947-002 Feb 13, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Eisai Inc LENVIMA lenvatinib mesylate CAPSULE;ORAL 206947-001 Feb 13, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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
Patent: DERIVADO DE QUINOLINA MUY PURO Y MÉTODO PARA SU PRODUCCIÓN
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 15309862
Patent: High-purity quinoline derivative and method for manufacturing same
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2017002827
Patent: derivado de quinolina altamente puro e método para produção do mesmo
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 57005
Patent: DERIVE DE QUINOLINE DE PURETE ELEVEE ET SON PROCEDE DE FABRICATION (HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME)
Estimated Expiration: ⤷  Sign Up

China

Patent: 6660964
Patent: 高纯度喹啉衍生物及其生产方法 (High-purity quinoline derivative and method for manufacturing same)
Estimated Expiration: ⤷  Sign Up

Patent: 3683564
Patent: 高纯度喹啉衍生物及其生产方法 (HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME)
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0221047
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 24595
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 87491
Patent: DÉRIVÉ DE QUINOLINE DE PURETÉ ÉLEVÉE ET SON PROCÉDÉ DE FABRICATION (HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME)
Estimated Expiration: ⤷  Sign Up

Patent: 24595
Patent: DÉRIVÉ DE QUINOLINE À PURETÉ ÉLEVÉE ET SON PROCÉDÉ DE FABRICATION (HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME)
Estimated Expiration: ⤷  Sign Up

Patent: 25305
Patent: PROCÉDÉ DE FABRICATION DE LENVATINIB (PROCESS FOR PREPARING LENVATINIB)
Estimated Expiration: ⤷  Sign Up

Patent: 89076
Patent: DÉRIVÉ DE QUINOLINE À PURETÉ ÉLEVÉE ET SON PROCÉDÉ DE FABRICATION (HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 59606
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 0454
Patent: תולדות קווינולין בדרגת נקיון גבוהה ושיטה להכנתן (High-purity quinoline derivative and method for manufacturing same)
Estimated Expiration: ⤷  Sign Up

Patent: 2218
Patent: תולדות קווינולין בדרגת נקיון גבוהה ושיטה להכנתן (High-purity quinoline derivative and method for manufacturing same)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 2016031841
Patent: 高純度キノリン誘導体およびその製造方法
Estimated Expiration: ⤷  Sign Up

Patent: 59554
Estimated Expiration: ⤷  Sign Up

Jordan

Patent: 0200225
Patent: مشتق كوينولين عالي النقاء وطريقة لإنتاجه (HIGHLY PURE QUINOLINE DERIVATIVE AND METHOD FOR PRODUCING THE SAME)
Estimated Expiration: ⤷  Sign Up

Patent: 83
Patent: مشتق كوينولين عالي النقاء وطريقة لإنتاجه (HIGHLY PURE QUINOLINE DERIVATIVE AND METHOD FOR PRODUCING THE SAME)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 24595
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 17001980
Patent: DERIVADO DE QUINOLINA MUY PURO Y METODO PARA SU PRODUCCION. (HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME.)
Estimated Expiration: ⤷  Sign Up

Patent: 22009299
Patent: DERIVADO DE QUINOLINA MUY PURO Y METODO PARA SU PRODUCCION. (HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME.)
Estimated Expiration: ⤷  Sign Up

Patent: 22009300
Patent: DERIVADO DE QUINOLINA MUY PURO Y METODO PARA SU PRODUCCION. (HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME.)
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 24595
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 24595
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 17104496
Patent: ПРОИЗВОДНОЕ ХИНОЛИНА ВЫСОКОЙ ЧИСТОТЫ И СПОСОБ ЕГО ПОЛУЧЕНИЯ
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 559
Patent: DERIVAT HINOLINA VELIKE ČISTOĆE I POSTUPAK ZA NJEGOVU PROIZVODNJU (HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 202100272R
Patent: HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME
Estimated Expiration: ⤷  Sign Up

Patent: 201700855X
Patent: HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 24595
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2329681
Estimated Expiration: ⤷  Sign Up

Patent: 2512940
Estimated Expiration: ⤷  Sign Up

Patent: 170043516
Patent: 고순도의 퀴놀린 유도체 및 이를 제조하는 방법 (HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME)
Estimated Expiration: ⤷  Sign Up

Patent: 210144916
Patent: 고순도의 퀴놀린 유도체 및 이를 제조하는 방법 (HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME)
Estimated Expiration: ⤷  Sign Up

Patent: 230043234
Patent: 고순도의 퀴놀린 유도체 및 이를 제조하는 방법 (HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 26687
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 21954
Estimated Expiration: ⤷  Sign Up

Patent: 1625544
Patent: High-purity quinoline derivative and method for manufacturing same
Estimated Expiration: ⤷  Sign Up

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
Slovenia 3263106 ⤷  Sign Up
Croatia P20231692 ⤷  Sign Up
China 101337933 Crystal of salt of 4-(3-chloro-4-(cyclopropylaminocarbonyl)amino-phenoxy)-7-methoxy-6-quinolinecarboxamide or of solvate thereof and processes for producing these ⤷  Sign Up
European Patent Office 3263106 PROCÉDÉ DE SUPPRESSION DE L'AMERTUME D'UN DÉRIVÉ DE QUINOLÉINE (METHOD FOR SUPPRESSING BITTERNESS OF QUINOLINE DERIVATIVE) ⤷  Sign Up
Russian Federation 2017128583 СПОСОБ ОСЛАБЛЕНИЯ ГОРЕЧИ ХИНОЛИНОВОГО ПРОИЗВОДНОГО ⤷  Sign Up
Cyprus 1107491 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for lenvima

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1415987 132016000024218 Italy ⤷  Sign Up PRODUCT NAME: LENVATINIB O UN SUO SALE ACCETTABILE FARMACEUTICAMENTE O SUO IDRATO(LENVIMA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1002/001-002, 20150601
1415987 CA 2015 00053 Denmark ⤷  Sign Up 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
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
1698623 261 5023-2015 Slovakia ⤷  Sign Up PRODUCT NAME: LENVATINIB MESYLAT; REGISTRATION NO/DATE: EU/1/15/1002/001 - EU/1/15/1002/002 20150601
1698623 C20150042 00382 Estonia ⤷  Sign Up PRODUCT NAME: LENVATINIIB;REG NO/DATE: EU/1/15/1002 01.06.2015
>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.