Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Fuji
Moodys
AstraZeneca
US Department of Justice
Deloitte
Baxter
Chinese Patent Office
Argus Health

Generated: November 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208434

« Back to Dashboard

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
Generic Entry Opportunity Date for 208434
Generic Entry Date for 208434*:
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: 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

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Johnson and Johnson
Colorcon
Merck
AstraZeneca
McKinsey
Boehringer Ingelheim
Citi
Deloitte

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.