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Nilotinib hydrochloride - Generic Drug Details

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What are the generic sources for nilotinib hydrochloride and what is the scope of nilotinib hydrochloride patent protection?

Nilotinib hydrochloride is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for nilotinib hydrochloride. One supplier is listed for this compound.

Summary for nilotinib hydrochloride

US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	10
Suppliers / Packagers:	1
Bulk Api Vendors:	10
Clinical Trials:	161
Patent Applications:	72
Formulation / Manufacturing:	see details
DailyMed Link:	nilotinib hydrochloride at DailyMed

Pharmacology for nilotinib hydrochloride

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Synonyms for nilotinib hydrochloride

3929AH

4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(pyridin-3-yl)pyrimidin-2-yl)amino)benzamide hydrochloride

4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide hydrochloride

923288-95-3

AKOS027422786

Benzamide, 4-methyl-N-(3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(3-pyridinyl)-2-pyrimidinyl)amino)-, hydrochloride (1:1)

C28H22F3N7O.ClH

DTXSID60238968

K37N7BYX3X

Nilotinib HCl

Nilotinib hydrochloride anhydrous

SCHEMBL434496

UNII-K37N7BYX3X

VTGGYCCJUPYZSX-UHFFFAOYSA-N

US Patents and Regulatory Information for nilotinib hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-002	Jun 17, 2010		RX	Yes	No
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-003	Mar 22, 2018		RX	Yes	No
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-003	Mar 22, 2018		RX	Yes	No					Y
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-001	Oct 29, 2007		RX	Yes	Yes

International Patents for nilotinib hydrochloride

Country	Document Number	Estimated Expiration
Japan	5829615
Peru	06472004
Japan	2009502796
Spain	2367319