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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Express Scripts
Cantor Fitzgerald

Generated: December 11, 2017

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


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 50242-130-01 1 BOTTLE, PLASTIC in 1 CARTON (50242-130-01) > 240 CAPSULE in 1 BOTTLE, PLASTIC
ALECENSA alectinib hydrochloride CAPSULE;ORAL 208434 NDA Genentech, Inc. 50242-130 50242-130-86 1 BOTTLE, PLASTIC in 1 CARTON (50242-130-86) > 240 CAPSULE in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Dec 11, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 11, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Dec 11, 2022
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:► SubscribePatent Expiration:May 29, 2031Product Flag?Substance Flag?YDelist Request?

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Fish and Richardson
Chinese Patent Office
Queensland Health
Johnson and Johnson
Daiichi Sankyo

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