DrugPatentWatch Database Preview
LENVIMA Drug Profile
» See Plans and Pricing
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 five patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and twenty-six patent family members in thirty-four 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: | 126 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 122 |
| Clinical Trials: | 23 |
| Patent Applications: | 1,232 |
| 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 |
|---|---|
| Massachusetts General Hospital | Phase 2 |
| Merck Sharp & Dohme Corp. | Phase 3 |
| Shanghai Jiahui International Hospital | 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 | NDA | Submissiondate |
|---|---|---|---|---|
| LENVIMA | CAPSULE;ORAL | lenvatinib mesylate | 206947 | 2019-02-13 |
US Patents and Regulatory Information for LENVIMA
| 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 | Start Trial | Start Trial | Start Trial | ||||
| Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-002 | Feb 13, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-001 | Feb 13, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-001 | Feb 13, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-002 | Feb 13, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-002 | Feb 13, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-001 | Feb 13, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Norway | 20063383 | Start Trial |
| Denmark | 1415987 | Start Trial |
| Australia | 2001295986 | Start Trial |
| Germany | 60126997 | Start Trial |
| Malaysia | 139232 | Start Trial |
| Singapore | 11201700855X | Start Trial |
| Japan | WO2016031841 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for LENVIMA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1415987 | C01415987/01 | Switzerland | Start Trial | PRODUCT NAME: LENVATINIB; REGISTRATION NO/DATE: SWISSMEDIC 65512 19.08.2015 |
| 1698623 | PA2015039 | Lithuania | Start Trial | PRODUCT NAME: LENVATINIBUM; REGISTRATION NO/DATE: EU/1/15/1002/001 - 002 20150528 |
| 1415987 | 92858 | Luxembourg | Start Trial | PRODUCT NAME: LENVATINIB, OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU UN HYDRATE DE CELUI-CI |
| 1415987 | 2015/050 | Ireland | Start Trial | PRODUCT NAME: LENVATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTRATION NO/DATE: EU/1/15/1002/001-/002 20150528 |
| 1415987 | 1590053-3 | Sweden | Start Trial | PRODUCT NAME: LENVATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REG. NO/DATE: EU/1/15/1002 20150601 |
| 1415987 | 122015000083 | Germany | Start Trial | PRODUCT NAME: LENVATINIB ODER EINES SEINER PHARMAZEUTISCH AKZEPTABLEN SALZE ODER EINES SEINER HYDRATE; REGISTRATION NO/DATE: EU/1/15/1002/001-002 20150528 |
| 1698623 | C 2015 041 | Romania | Start 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
