Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Baxter
Mallinckrodt
US Army
Medtronic
Farmers Insurance
Fuji
Chinese Patent Office
Covington
Colorcon
Deloitte

Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202806

« Back to Dashboard

NDA 202806 describes TAFINLAR, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug. Additional details are available on the TAFINLAR profile page.

The generic ingredient in TAFINLAR is dabrafenib mesylate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the dabrafenib mesylate profile page.
Summary for 202806
Tradename:TAFINLAR
Applicant:Novartis Pharms Corp
Ingredient:dabrafenib mesylate
Patents:6
Suppliers and Packaging for NDA: 202806
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806 NDA Novartis Pharmaceuticals Corporation 0078-0681 N 0078-0681-66
TAFINLAR dabrafenib mesylate CAPSULE;ORAL 202806 NDA Novartis Pharmaceuticals Corporation 0078-0682 N 0078-0682-66

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE
Approval Date:May 29, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 22, 2024
Regulatory Exclusivity Use:DABRAFENIB IN COMBINATION WITH TRAMETINIB, FOR THE TX. OF PTS WITH METASTATIC NON-SMALL CELL LUNG CANCERWITH BRAF V600E MUTATION AS DETECTED BY AN FDA-APPROVED TEST
Regulatory Exclusivity Expiration:Jan 9, 2021
Regulatory Exclusivity Use:DABRAFENIB IN COMBO WITH TRAMETINIB FOR TX. OF PTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST.THIS INDICATION IS BASED ON THE DEMONSTRATION OF DURABLE RESPONSE RATE
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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Fish and Richardson
Queensland Health
Cerilliant
Express Scripts
Chubb
Farmers Insurance
Moodys
AstraZeneca

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.

botpot