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Generated: November 16, 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. 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 profile page.
Summary for 022068
Tradename:TASIGNA
Applicant:Novartis
Ingredient:nilotinib hydrochloride
Patents:7
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022068
Generic Entry Date for 022068*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 CAPSULE;ORAL 022068 NDA Novartis Pharmaceuticals Corporation 0078-0526 0078-0526-51 28 CAPSULE in 1 BLISTER PACK (0078-0526-51)
TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068 NDA Novartis Pharmaceuticals Corporation 0078-0526 0078-0526-87 4 BLISTER PACK in 1 CARTON (0078-0526-87) > 28 CAPSULE in 1 BLISTER PACK

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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