BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Federal Trade Commission
McKesson
Boehringer Ingelheim
Accenture
Mallinckrodt
US Department of Justice
Baxter
Medtronic
Cipla

Generated: January 22, 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 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:Jun 22, 2020
Regulatory Exclusivity Use:
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:May 29, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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Serving leading biopharmaceutical companies globally:

UBS
Medtronic
Express Scripts
Cantor Fitzgerald
Cipla
Accenture
Citi
Deloitte
Fish and Richardson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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