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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 NDA: 208434

Hoffmann-la Roche
alectinib hydrochloride

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
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 150MG BASE
Approval Date:Dec 11, 2015TE:RLD:Yes
Patent:9,126,931Patent Expiration:May 29, 2031Product Flag?Substance Flag?YDelist Request?
Patent:9,365,514Patent Expiration:Mar 4, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:9,440,922Patent Expiration:Jun 9, 2030Product Flag?YSubstance Flag?Delist Request?

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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.