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The generic ingredient in COTELLIC is cobimetinib fumarate. Additional details are available on the cobimetinib fumarate profile page.
Generic Entry Opportunity Date for 206192
*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:||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:||Nov 10, 2020|
|Regulatory Exclusivity Use:||NEW CHEMICAL ENTITY|
|Patent:||Start Trial||Patent Expiration:||Jun 29, 2036||Product Flag?||Y||Substance Flag?||Y||Delist Request?|
|Patented Use:||METHOD OF USING COBIMETINIB FOR THE TREATMENT OF MELANOMA|
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