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BioPharmaceutical Business Intelligence

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  • Drug patents in 130+ countries

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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Citi
Fish and Richardson
US Army
Mallinckrodt
McKinsey
McKesson
Merck
Chinese Patent Office
AstraZeneca

Generated: September 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202806

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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 NDA: 202806

Tradename:
1
Applicant:
1
Ingredient:
1
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 0078-0681-66 120 CAPSULE in 1 BOTTLE (0078-0681-66)
TAFINLAR
dabrafenib mesylate
CAPSULE;ORAL 202806 NDA Novartis Pharmaceuticals Corporation 0078-0682 0078-0682-66 120 CAPSULE in 1 BOTTLE (0078-0682-66)

Summary 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, 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 500+ biopharmaceutical companies globally:

Federal Trade Commission
Express Scripts
Cerilliant
Fuji
Queensland Health
Teva
Chinese Patent Office
Deloitte
Colorcon
Baxter

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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