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Generated: November 15, 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
Generic Entry Opportunity Date for 204114
Generic Entry Date for 204114*:
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: 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 0078-0666-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-0666-15)
MEKINIST trametinib dimethyl sulfoxide TABLET;ORAL 204114 NDA Novartis Pharmaceuticals Corporation 0078-0668 0078-0668-15 30 TABLET, FILM COATED in 1 BOTTLE (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:Apr 30, 2021
Regulatory Exclusivity Use:DABRAFENIB IN COMBINATION WITH TRAMETINIB FOR THE ADJUVANT TREATMENT OF PATIENTS WITH MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST, AND INVOLVEMENT OF LYMPH NODE(S), FOLLOWING COMPLETE RESECTION
Regulatory Exclusivity Expiration:May 4, 2021
Regulatory Exclusivity Use:DABRAFENIB IN COMBINATION WITH TRAMETINIB FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ANAPLASTIC THYROID CANCER (ATC) WITH BRAF V600E MUTATION AND WITH NO SATISFACTORY LOCOREGIONAL TREATMENT OPTIONS
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

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Daiichi Sankyo
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