Lenvatinib mesylate - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for lenvatinib mesylate and what is the scope of patent protection?
Lenvatinib mesylate
is the generic ingredient in one branded drug marketed by Eisai Inc and is included in one NDA. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Lenvatinib mesylate has one hundred and sixty-seven patent family members in thirty-six countries.
There are three drug master file entries for lenvatinib mesylate. One supplier is listed for this compound.
Summary for lenvatinib mesylate
| International Patents: | 167 |
| US Patents: | 7 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 3 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 60 |
| Clinical Trials: | 13 |
| Patent Applications: | 645 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for lenvatinib mesylate |
| DailyMed Link: | lenvatinib mesylate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for lenvatinib mesylate
Generic Entry Date for lenvatinib mesylate*:
Constraining patent/regulatory exclusivity:
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 lenvatinib mesylate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Henan Cancer Hospital | Phase 2 |
| Shanghai Junshi Bioscience Co., Ltd. | Phase 3 |
| RenJi Hospital | N/A |
Pharmacology for lenvatinib mesylate
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Receptor Tyrosine Kinase Inhibitors |
Paragraph IV (Patent) Challenges for LENVATINIB MESYLATE
| 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 lenvatinib mesylate
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-002 | Feb 13, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-001 | Feb 13, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-002 | Feb 13, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Eisai Inc | LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947-001 | Feb 13, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 lenvatinib mesylate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Luxembourg | 92858 | ⤷ Try a Trial | |
| South Korea | 100870681 | ⤷ Try a Trial | |
| Japan | 2010280713 | CRYSTAL OF SALT OF 4-(3-CHLORO-4-(CYCLOPROPYLAMINOCARBONYL)AMINOPHENOXY)-7-METHOXY-6-QUINOLINECARBOXAMIDE OR SOLVATE THEREOF, AND PROCESS FOR PREPARING THE SAME | ⤷ Try a Trial |
| Denmark | 3524595 | ⤷ Try a Trial | |
| Brazil | PI0418200 | forma cristalina do sal de 4-(3-cloro-4-(ciclopropilaminocarbonila) aminofenóxi)-7-metóxi-6-quinolinacarboxamida ou o solvato do sal e um processo para a sua preparação | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for lenvatinib mesylate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1415987 | 57/2015 | Austria | ⤷ Try a Trial | 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 | 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 | PA2015039,C1698623 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: LENVATINIBAS; REGISTRATION NO/DATE: EU/1/15/1002/001 - 002 20150528 |
| 1415987 | SPC/GB15/063 | United Kingdom | ⤷ Try a Trial | 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 | 2015/050 | Ireland | ⤷ Try a Trial | 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 |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - HIPAA-ready chat for life sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
