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Chubb
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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204114

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NDA 204114 describes MEKINIST, which is a drug marketed by Novartis Pharms Corp 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 MEKINIST profile page.

The generic ingredient in MEKINIST is trametinib dimethyl sulfoxide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the trametinib dimethyl sulfoxide profile page.
Summary for 204114
Tradename:MEKINIST
Applicant:Novartis Pharms Corp
Ingredient:trametinib dimethyl sulfoxide
Patents:7
Pharmacology for NDA: 204114
Mechanism of ActionProtein Kinase Inhibitors
Suppliers and Packaging for NDA: 204114
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114 NDA Novartis Pharmaceuticals Corporation 0078-0666 N 0078-0666-15
MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114 NDA Novartis Pharmaceuticals Corporation 0078-0668 N 0078-0668-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.5MG
Approval Date:May 29, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 20, 2018
Regulatory Exclusivity Use:INFORMATION ADDED TO THE CLINICAL STUDIES SECTION REGARDING USE FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
Regulatory Exclusivity Expiration:Jun 22, 2020
Regulatory Exclusivity Use:MEKINIST, IN COMBINATION WITH DABRAFENIB, FOR THE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST.
Regulatory Exclusivity Expiration:May 29, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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