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 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
Summary for LENVIMA
International Patents: | 133 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 140 |
Clinical Trials: | 41 |
Patent Applications: | 404 |
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 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
Sponsor | Phase |
---|---|
Elizabeth K. Lee MD | Phase 2 |
AstraZeneca | Phase 3 |
National University Hospital, Singapore | Phase 2 |
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 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
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 |