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Serving leading biopharmaceutical companies globally:

McKesson
Novartis
Chubb
McKinsey
UBS
Queensland Health
Federal Trade Commission
Accenture
Healthtrust
Merck

Generated: November 21, 2017

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

The generic ingredient in LENVIMA is lenvatinib mesylate. One supplier is listed for this compound. Additional details are available on the lenvatinib mesylate profile page.

Summary for 206947

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:3

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. 62856-708 62856-708-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (62856-708-30) > 10 CAPSULE in 1 BLISTER PACK (62856-708-05)
LENVIMA
lenvatinib mesylate
CAPSULE;ORAL 206947 NDA Eisai Inc. 62856-710 62856-710-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (62856-710-30) > 5 CAPSULE in 1 BLISTER PACK (62856-710-05)

Summary 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:Feb 13, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Feb 13, 2022
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY


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Serving leading biopharmaceutical companies globally:

Deloitte
Queensland Health
Chubb
Boehringer Ingelheim
McKesson
Merck
Accenture
AstraZeneca
Johnson and Johnson
Federal Trade Commission

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