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 six 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.
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: | 6 |
DrugPatentWatch® Estimated 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.
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: | 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: | 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 | ||||||||
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