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Nilotinib hydrochloride - Generic Drug Details

What are the generic sources for nilotinib hydrochloride and what is the scope of nilotinib hydrochloride freedom to operate?

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.

Nilotinib hydrochloride has two hundred and sixty-two patent family members in fifty countries.

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

Summary for nilotinib hydrochloride

International Patents:	262
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	11
Suppliers / Packagers:	1
Bulk Api Vendors:	12
Clinical Trials:	166
Patent Applications:	77
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

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Glossary

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

International Patents for nilotinib hydrochloride

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Country	Document Number	Estimated Expiration
Eurasian Patent Organization	013464	➤ Sign Up
Hong Kong	1116778	➤ Sign Up
New Zealand	564182	➤ Sign Up
Country	Document Number	Estimated Expiration