Details for New Drug Application (NDA): 206192
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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 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) |
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: | 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, 2025 | ||||||||
Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH HISTIOCYTIC NEOPLASMS |
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