LENVIMA Drug Patent Profile
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When do Lenvima patents expire, and when can generic versions of Lenvima launch?
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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Questions you can ask:
- What is the 5 year forecast for LENVIMA?
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Summary for LENVIMA
| International Patents: | 180 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 59 |
| Clinical Trials: | 54 |
| Patent Applications: | 204 |
| 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
*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 Medical Center Groningen | Phase 4 |
| Tongji Hospital | Phase 3 |
| University of California, San Francisco | Phase 2 |
Pharmacology for LENVIMA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Receptor Tyrosine Kinase Inhibitors |
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 | |||
| 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 |
|---|---|---|---|
| Norway | 326781 | ⤷ Sign Up | |
| Brazil | 112017017428 | ?método para supressão do amargor de derivado de quinolina? | ⤷ Sign Up |
| Portugal | 1415987 | ⤷ Sign Up | |
| Hungary | E059606 | ⤷ Sign Up | |
| Australia | 2004309217 | 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 |
| Finland | 3263106 | ⤷ Sign Up | |
| Taiwan | 200528432 | The method of producing the crystal of 4-(3-chloro-4-(cyclopropylaminocarbonyl)amino-phenoxy)-7-methoxy -6-quinolinecarboxamide or of solvate thereof and processes for producing these | ⤷ 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 | 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 |
| 1415987 | 92858 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: LENVATINIB, OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU UN HYDRATE DE CELUI-CI |
| 1698623 | C20150042 00382 | Estonia | ⤷ Sign Up | PRODUCT NAME: LENVATINIIB;REG NO/DATE: EU/1/15/1002 01.06.2015 |
| 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 |
| 1698623 | PA2015039 | Lithuania | ⤷ Sign Up | PRODUCT NAME: LENVATINIBUM; REGISTRATION NO/DATE: EU/1/15/1002/001 - 002 20150528 |
| 1415987 | CR 2015 00053 | Denmark | ⤷ Sign Up | PRODUCT NAME: LENVATINIB, ELLER ET FARMAKOLOGISK ACCEPTABELT SALT DERAF ELLER ET HYDRAT DERAF, HERUNDER LENVATINIB MESILAT; REG. NO/DATE: EU/1/15/1002/001-002 20150601 |
| 1415987 | 2015/050 | Ireland | ⤷ Sign Up | PRODUCT NAME: LENVATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; 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.
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