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Serving 500+ biopharmaceutical companies globally:

Queensland Health
US Army

Generated: July 25, 2017

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 six 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 NDA: 204114


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
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)
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.5MG
Approval Date:May 29, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 22, 2020
Regulatory Exclusivity Use:
Patent:► SubscribePatent Expiration:Sep 13, 2025Product Flag?YSubstance Flag?YDelist Request?
Patent:► SubscribePatent Expiration:Jan 28, 2032Product Flag?YSubstance Flag?Delist Request?

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Serving 500+ biopharmaceutical companies globally:

Queensland Health
US Army
Federal Trade Commission
Johnson and Johnson
Cantor Fitzgerald
US Department of Justice
Fish and Richardson

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