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Daiichi Sankyo
Cerilliant
Colorcon
Cipla
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Cantor Fitzgerald
Teva
Moodys
Deloitte
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Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208434

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NDA 208434 describes ALECENSA, which is a drug marketed by Hoffmann-la Roche 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 ALECENSA profile page.

The generic ingredient in ALECENSA is alectinib hydrochloride. One supplier is listed for this compound. Additional details are available on the alectinib hydrochloride profile page.
Summary for 208434
Tradename:ALECENSA
Applicant:Hoffmann-la Roche
Ingredient:alectinib hydrochloride
Patents:3
Pharmacology for NDA: 208434
Mechanism of ActionKinase Inhibitors
Suppliers and Packaging for NDA: 208434
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALECENSA alectinib hydrochloride CAPSULE;ORAL 208434 NDA Genentech, Inc. 50242-130 N 50242-130-86
ALECENSA alectinib hydrochloride CAPSULE;ORAL 208434 NDA Genentech, Inc. 50242-130 N 50242-130-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Dec 11, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 6, 2020
Regulatory Exclusivity Use:EXPANDED THE APPROVED INDICATION BY REMOVING THE RESTRICTION FOR USE ONLY IN PATIENTS WHO HAVE PROGRESSED ON OR ARE INTOLERANT TO CRIZOTINIB
Regulatory Exclusivity Expiration:Nov 6, 2024
Regulatory Exclusivity Use:FOR TREATMENT OF PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK) POSITIVE, METASTATIC NON-SMALL-CELL LUNG CANCER (NSCLC) AS DETECTED BY AN FDA APPROVED TEST, EXCLUDING PATIENTS WHO HAVE PROGRESSED ON OR ARE INTOLERANT TO CRIZOTINIB
Regulatory Exclusivity Expiration:Dec 11, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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Colorcon
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