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Last Updated: April 24, 2024

Lenvatinib mesylate - Generic Drug Details


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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.

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

SponsorPhase
Henan Cancer HospitalPhase 2
Shanghai Junshi Bioscience Co., Ltd.Phase 3
RenJi HospitalN/A

See all lenvatinib mesylate clinical trials

Pharmacology for lenvatinib mesylate
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 206947-001 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 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
Russian Federation 2264389 АЗОТСОДЕРЖАЩИЕ АРОМАТИЧЕСКИЕ ПРОИЗВОДНЫЕ, ИХ ПРИМЕНЕНИЕ, ЛЕКАРСТВЕННОЕ СРЕДСТВО НА ИХ ОСНОВЕ И СПОСОБ ЛЕЧЕНИЯ (NITROGEN-CONTAINING AROMATIC DERIVATIVES, THEIR USING, MEDICINAL AGENT BASED ON THEREOF AND METHOD FOR TREATMENT) ⤷  Try a Trial
Israel 175933 CRYSTALLINE FORM OF THE SALT OF 4-(3-CHLORO-4-(CYCLOPROPYLAMINOCARBONYL)AMINOPHENOXY)-7-METHOXY-6-QUINOLINECARBOXAMIDE OR THE SOLVATE OF THE SALT, A PHARMACEUTICAL COMPOSITION COMPRISING THE SAME AND A PROCESS FOR PREPARING THE SAME ⤷  Try a Trial
South Africa 200605226 A crystalline form of the salt of 4-(3-chloro-4-(cyclo-propylaminocarbonyl)aminophenoxy)-7-methoxy-6-quinolinecarboxamide or the solvate of the salt and a process for preparing the same ⤷  Try a Trial
Croatia P20231692 ⤷  Try a Trial
South Korea 20210144916 고순도의 퀴놀린 유도체 및 이를 제조하는 방법 (HIGH-PURITY QUINOLINE DERIVATIVE AND METHOD FOR MANUFACTURING SAME) ⤷  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 C01415987/01 Switzerland ⤷  Try a Trial PRODUCT NAME: LENVATINIB; REGISTRATION NO/DATE: SWISSMEDIC 65512 19.08.2015
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
1415987 553 Finland ⤷  Try a Trial
1698623 PA2015039 Lithuania ⤷  Try a Trial PRODUCT NAME: LENVATINIBUM; 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
>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.