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 eleven 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

Pharmacology for NDA: 022068

Mechanism of Action	Bcr-Abl Tyrosine Kinase Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 2C8 Inducers Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors P-Glycoprotein Inhibitors UGT1A1 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:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 200MG BASE
Approval Date:	Oct 29, 2007	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Mar 23, 2029
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:	Sep 22, 2025
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:	Sep 23, 2028
Regulatory Exclusivity Use:	TREATMENT OF PEDIATRIC PATIENTS GREATER THAN OR EQUAL TO 1 YEAR OF AGE WITH ACCELERATED PHASE PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH+ CML) WITH RESISTANCE OR INTOLERANCE TO PRIOR TYROSINE-KINASE INHIBITOR (TKI) THERAPY

Expired US Patents for NDA 022068

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-003	Mar 22, 2018	⤷ Sign Up	⤷ Sign Up
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-001	Oct 29, 2007	⤷ Sign Up	⤷ Sign Up
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-002	Jun 17, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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