Last Updated: November 4, 2026

Details for New Drug Application (NDA): 206192

✉ Email this page to a colleague

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. There is one drug master file entry for this compound. 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^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: 7,803,839PED 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 Action	Kinase 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)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	Nov 10, 2015	TE:		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, 2029
Regulatory Exclusivity Use:	TREATMENT OF ADULT PATIENTS WITH HISTIOCYTIC NEOPLASMS

Expired US Patents for NDA 206192

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genentech Inc	COTELLIC	cobimetinib fumarate	TABLET;ORAL	206192-001	Nov 10, 2015	11,597,699	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.