Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206947

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NDA 206947 describes LENVIMA, which is a drug marketed by Eisai Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LENVIMA profile page.

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.
Summary for 206947
Tradename:LENVIMA
Applicant:Eisai Inc
Ingredient:lenvatinib mesylate
Patents:5
Generic Entry Opportunity Date for 206947
Generic Entry Date for 206947*:
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.

Pharmacology for NDA: 206947
Suppliers and Packaging for NDA: 206947
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LENVIMA lenvatinib mesylate CAPSULE;ORAL 206947 NDA Eisai Inc. 62856-704 62856-704-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (62856-704-30) > 5 CAPSULE in 1 BLISTER PACK (62856-704-05)
LENVIMA lenvatinib mesylate CAPSULE;ORAL 206947 NDA Eisai Inc. 62856-708 62856-708-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (62856-708-30) > 10 CAPSULE in 1 BLISTER PACK (62856-708-05)
Paragraph IV (Patent) Challenges for 206947
Tradename Dosage Ingredient NDA Submissiondate
LENVIMA CAPSULE;ORAL lenvatinib mesylate 206947 2019-02-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 4MG BASE
Approval Date:Feb 13, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:May 13, 2019
Regulatory Exclusivity Use:EXPANDED INDICATION FOR THE USE OF LENVIMA IN COMBINATION WITH EVEROLIMUS FOR THE TREATMENT OF PATIENTS WITH ADVANCED RCC FOLLOWING ONE PRIOR ANTI-ANGIOGENIC THERAPY.
Regulatory Exclusivity Expiration:Aug 15, 2021
Regulatory Exclusivity Use:FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC)
Regulatory Exclusivity Expiration:Aug 15, 2025
Regulatory Exclusivity Use:INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC)

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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 verifification 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.