You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 4, 2024

Details for New Drug Application (NDA): 206192


✉ Email this page to a colleague

« Back to Dashboard


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 seven 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:7
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.

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 50242-717-01 63 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50242-717-01)
COTELLIC cobimetinib fumarate TABLET;ORAL 206192 NDA Genentech, Inc. 50242-717 50242-717-86 63 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (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:Jul 28, 2025
Regulatory Exclusivity Use:INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULT OF STUDY GO29665
Regulatory Exclusivity Expiration:Jan 28, 2026
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Oct 28, 2025
Regulatory Exclusivity Use:TREATMENT OF ADULT PATIENTS WITH HISTIOCYTIC NEOPLASMS

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.