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Generated: November 14, 2018

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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 three patents protecting this drug. Additional details are available on the LENVIMA profile page.

The generic ingredient in LENVIMA is lenvatinib mesylate. There are three 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:3
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)

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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