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Last Updated: March 30, 2020

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. There are three patents protecting this drug. Additional details are available on the COTELLIC profile page.

The generic ingredient in COTELLIC is cobimetinib fumarate. Additional details are available on the cobimetinib fumarate profile page.
Summary for 206192
Tradename:COTELLIC
Applicant:Genentech Inc
Ingredient:cobimetinib fumarate
Patents:3
Generic Entry Opportunity Date for 206192
Generic Entry Date for 206192*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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.

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:  Start TrialPatent Expiration:Jun 29, 2036Product Flag?YSubstance Flag?YDelist Request?
Patented Use:METHOD OF USING COBIMETINIB FOR THE TREATMENT OF MELANOMA

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