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
Summary for LENVIMA
International Patents: | 160 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 59 |
Clinical Trials: | 52 |
Patent Applications: | 295 |
Drug Prices: | Drug price information for LENVIMA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LENVIMA |
What excipients (inactive ingredients) are in LENVIMA? | LENVIMA excipients list |
DailyMed Link: | LENVIMA at DailyMed |


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
Sponsor | Phase |
---|---|
University of California, San Francisco | Phase 2 |
Glenn J. Hanna | Phase 1/Phase 2 |
Cellestia Biotech AG | Phase 1/Phase 2 |
Pharmacology for LENVIMA
Drug Class | Kinase Inhibitor |
Mechanism of Action | Receptor Tyrosine Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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
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 |
---|---|---|---|
European Patent Office | 3524595 | DÉRIVÉ DE QUINOLINE À PURETÉ ÉLEVÉE ET SON PROCÉDÉ DE FABRICATION (HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME) | ⤷ Try a Trial |
European Patent Office | 1415987 | COMPOSES HETEROAROMATIQUES AZOTES POUR LE TRAITEMENT DES MALADIES DE CANCER (NITROGENOUS AROMATIC RING COMPOUNDS AS ANTI CANCER AGENTS) | ⤷ Try a Trial |
Japan | 2005272474 | NITROGEN-CONTAINING AROMATIC RING DERIVATIVE | ⤷ Try a Trial |
Germany | 60126997 | ⤷ Try a Trial | |
Hungary | E059606 | ⤷ Try a Trial | |
China | 101029022 | ⤷ Try a Trial | |
Israel | 189677 | ⤷ 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 |
---|---|---|---|---|
1698623 | C 2015 041 | Romania | ⤷ Try a 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 | 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 |
1415987 | 300764 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LENVATINIB, EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, OF EEN HYDRAAT DAARVAN; REGISTRATION NO/DATE: EU/1/15/1002/001 -002 20150528 |
1698623 | C20150042 00382 | Estonia | ⤷ Try a Trial | PRODUCT NAME: LENVATINIIB;REG NO/DATE: EU/1/15/1002 01.06.2015 |
1415987 | 92858 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: LENVATINIB, OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU UN HYDRATE DE CELUI-CI |
1415987 | 15C0070 | France | ⤷ Try a 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 | 1590053-3 | Sweden | ⤷ Try a 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 |