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Serving leading biopharmaceutical companies globally:

Fish and Richardson
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US Army
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Healthtrust
Johnson and Johnson
Covington
McKesson
QuintilesIMS
Novartis

Generated: February 18, 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 nine 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 0078-0526-51
TASIGNA nilotinib hydrochloride monohydrate CAPSULE;ORAL 022068 NDA Novartis Pharmaceuticals Corporation 0078-0526 N 0078-0526-87

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 200MG BASE
Approval Date:Oct 29, 2007TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 22, 2020
Regulatory Exclusivity Use:TO ALLOW WITHDRAWAL THERAPY OF PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA IN CHRONIC PHASE WHO HAVE ACHIEVED A SUSTAINED MOLECULAR RESPONSE ON NILOTINIB THERAPY FOR A MINIMUM OF ONE YEAR PRIOR TO DISCONTINUATION
Patent:➤ Try a Free TrialPatent Expiration:Jul 4, 2023Product Flag?YSubstance Flag?YDelist Request?
Patented Use:A METHOD FOR THE TREATMENT OF LEUKEMIAS
Patent:➤ Try a Free TrialPatent Expiration:Aug 23, 2028Product Flag?YSubstance Flag?YDelist Request?

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