Claim Your New User Special: Get your second month free ▶ Second Month Free

Serving leading biopharmaceutical companies globally:

Moodys
McKesson
Johnson and Johnson
Boehringer Ingelheim
Medtronic
Harvard Business School

Last Updated: May 26, 2022

LENVIMA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

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 six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty-three 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 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

< Available with Subscription >

  Sign up for a Free Trial

Drug patent expirations by year for LENVIMA
Drug Prices for LENVIMA

See drug prices for LENVIMA

DrugPatentWatch® Estimated 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
Elizabeth K. Lee MDPhase 2
AstraZenecaPhase 3
National University Hospital, SingaporePhase 2

See all LENVIMA clinical trials

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 six US patents and six FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of LENVIMA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

High-purity quinoline derivative and method for manufacturing same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

High-purity quinoline derivative and method for manufacturing same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Nitrogen-containing aromatic derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Antitumor agent for thyroid cancer
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR TREATING THYROID CARCINOMA INCLUDING DIFFERENTIATED THYROID CANCER

FDA Regulatory Exclusivity protecting LENVIMA

TREATMENT OF PATIENTS WITH LOCALLY RECURRENT OR METASTATIC, PROGRESSIVE, RADIOACTIVE IODINE REFRACTORY DIFFERENTIATED THYROID CANCER
Exclusivity Expiration: See Plans and Pricing

INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC)
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF ADVANCED ENDOMETRIAL CARCINOMA THAT IS NOT MICROSATELLITE INSTABILITY-HIGH OR MISMATCH REPAIR DEFICIENT, WHO HAVE DISEASE PROGRESSION FOLLOWING PRIOR SYSTEMIC THERAPY AND ARE NOT CANDIDATES FOR CURATIVE SURGERY OR RADIATION
Exclusivity Expiration: See Plans and Pricing

REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY 309/KEYNOTE-775 TO SUPPORT PMR 3696-1 AND 3700-1
Exclusivity Expiration: See Plans and Pricing

LENVATINIB IN COMBINATION WITH PEMBROLIZUMAB, IS INDICATED FOR THE FIRST-LINE TREATMENT OF ADULT PATIENTS WITH ADVANCED RENAL CELL CARCINOMA (RCC)
Exclusivity Expiration: See Plans and Pricing

REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY E7080-G000-211 TO SUPPORT PMR 2865-1
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eisai Inc LENVIMA lenvatinib mesylate CAPSULE;ORAL 206947-002 Feb 13, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Eisai Inc LENVIMA lenvatinib mesylate CAPSULE;ORAL 206947-002 Feb 13, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eisai Inc LENVIMA lenvatinib mesylate CAPSULE;ORAL 206947-001 Feb 13, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eisai Inc LENVIMA lenvatinib mesylate CAPSULE;ORAL 206947-001 Feb 13, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Eisai Inc LENVIMA lenvatinib mesylate CAPSULE;ORAL 206947-001 Feb 13, 2015 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 15309862
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2017002827
Estimated Expiration: See Plans and Pricing

Canada

Patent: 57005
Estimated Expiration: See Plans and Pricing

China

Patent: 6660964
Estimated Expiration: See Plans and Pricing

Patent: 3683564
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 87491
Estimated Expiration: See Plans and Pricing

Patent: 24595
Estimated Expiration: See Plans and Pricing

Patent: 25305
Estimated Expiration: See Plans and Pricing

Israel

Patent: 0454
Estimated Expiration: See Plans and Pricing

Japan

Patent: 2016031841
Estimated Expiration: See Plans and Pricing

Patent: 59554
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 0200225
Estimated Expiration: See Plans and Pricing

Patent: 83
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 17001980
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 17104496
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 202100272R
Estimated Expiration: See Plans and Pricing

Patent: 201700855X
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2329681
Estimated Expiration: See Plans and Pricing

Patent: 170043516
Estimated Expiration: See Plans and Pricing

Patent: 210144916
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 21954
Estimated Expiration: See Plans and Pricing

Patent: 1625544
Estimated Expiration: See Plans and Pricing

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
Singapore 11201700855X HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME See Plans and Pricing
Hong Kong 1102027 CRYSTAL (C) OF MESYLATE OF 4-(3-CHLORO-4-(CYCLOPROPYLAMINOCARBONYL)AMINO- PHENOXY)-7-METHOXY-6-QUINOLINECARBOXAMIDE AND PROCESSES FOR PRODUCING THESE See Plans and Pricing
Japan 6659554 See Plans and Pricing
Singapore 10202100272R HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME See Plans and Pricing
South Korea 20170043516 고순도의 퀴놀린 유도체 및 이를 제조하는 방법 (HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME) See Plans and Pricing
South Korea 20030040552 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LENVIMA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1415987 92858 Luxembourg See Plans and Pricing PRODUCT NAME: LENVATINIB, OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU UN HYDRATE DE CELUI-CI
1415987 SPC/GB15/063 United Kingdom See Plans and Pricing PRODUCT NAME: LENVATINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR A HYDRATE THEREOF; REGISTERED: UK EU/1/15/1002/001-002 20150601
1415987 132016000024218 Italy See Plans and Pricing 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
1698623 261 5023-2015 Slovakia See Plans and Pricing PRODUCT NAME: LENVATINIB MESYLAT; REGISTRATION NO/DATE: EU/1/15/1002/001 - EU/1/15/1002/002 20150601
1415987 1590053-3 Sweden See Plans and Pricing PRODUCT NAME: LENVATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REG. NO/DATE: EU/1/15/1002 20150601
1415987 57/2015 Austria See Plans and Pricing PRODUCT NAME: LENVATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON ODER EIN HYDRAT DAVON; REGISTRATION NO/DATE: EU/1/15/1002/001-002 (MITTEILUNG) 20150601
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.