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Last Updated: November 2, 2024

LENVATINIB MESYLATE - Generic Drug Details


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What are the generic drug 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. There is one tentative approval 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

Generic filers with tentative approvals for LENVATINIB MESYLATE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up10MGCAPSULE; ORAL
⤷  Sign Up⤷  Sign Up4MGCAPSULE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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 206947-001 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 206947-002 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 ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for LENVATINIB MESYLATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1415987 553 Finland ⤷  Sign Up
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,C1698623 Lithuania ⤷  Sign Up PRODUCT NAME: LENVATINIBAS; REGISTRATION NO/DATE: EU/1/15/1002/001 - 002 20150528
1698623 261 5023-2015 Slovakia ⤷  Sign Up PRODUCT NAME: LENVATINIB MESYLAT; REGISTRATION NO/DATE: EU/1/15/1002/001 - EU/1/15/1002/002 20150601
1415987 C01415987/01 Switzerland ⤷  Sign Up PRODUCT NAME: LENVATINIB; REGISTRATION NO/DATE: SWISSMEDIC 65512 19.08.2015
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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