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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
McKesson
Citi
Argus Health
Farmers Insurance
Covington
Express Scripts
Fuji
Cerilliant

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022068

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NDA 022068 describes TASIGNA, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TASIGNA profile page.

The generic ingredient in TASIGNA is nilotinib hydrochloride monohydrate. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nilotinib hydrochloride monohydrate profile page.
Summary for 022068
Tradename:TASIGNA
Applicant:Novartis
Ingredient:nilotinib hydrochloride monohydrate
Patents:7
Formulation / Manufacturing:see details
Pharmacology for NDA: 022068
Mechanism of ActionProtein Kinase Inhibitors
Suppliers and Packaging for NDA: 022068
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TASIGNA nilotinib hydrochloride monohydrate CAPSULE;ORAL 022068 NDA Novartis Pharmaceuticals Corporation 0078-0526 N 0078-0526-87
TASIGNA nilotinib hydrochloride monohydrate CAPSULE;ORAL 022068 NDA Novartis Pharmaceuticals Corporation 0078-0526 N 0078-0526-51

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 200MG BASE
Approval Date:Oct 29, 2007TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 22, 2021
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Jun 22, 2021
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Sep 22, 2021
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Chinese Patent Office
Julphar
US Army
McKesson
Farmers Insurance
Argus Health
Moodys
Johnson and Johnson

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