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QuintilesIMS
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Cipla
Citi
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Generated: June 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206192

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NDA 206192 describes COTELLIC, which is a drug marketed by Genentech Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the COTELLIC profile page.

The generic ingredient in COTELLIC is cobimetinib fumarate. One supplier is listed for this compound. Additional details are available on the cobimetinib fumarate profile page.
Summary for 206192
Tradename:COTELLIC
Applicant:Genentech Inc
Ingredient:cobimetinib fumarate
Patents:2
Pharmacology for NDA: 206192
Mechanism of ActionKinase Inhibitors
Suppliers and Packaging for NDA: 206192
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COTELLIC cobimetinib fumarate TABLET;ORAL 206192 NDA Genentech, Inc. 50242-717 N 50242-717-01
COTELLIC cobimetinib fumarate TABLET;ORAL 206192 NDA Genentech, Inc. 50242-717 N 50242-717-86

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Nov 10, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 10, 2022
Regulatory Exclusivity Use:FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATION, IN COMBINATION WITH VEMURAFENIB. COTELLIC IS NOT INDICATED FOR TREATMENT OF PATIENTS WITH WILD-TYPE BRAF MELANOMA
Regulatory Exclusivity Expiration:Nov 10, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Feb 1, 2027Product Flag?YSubstance Flag?YDelist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Queensland Health
Deloitte
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US Department of Justice
Citi
Daiichi Sankyo
Colorcon
Fish and Richardson

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