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Nilotinib hydrochlorideis 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 seventy-two patent family members in fifty-one countries.
There are eleven drug master file entries for nilotinib hydrochloride. One supplier is listed for this compound.
Summary for nilotinib hydrochloride
Recent Clinical Trials for nilotinib hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|Hyewon Chung||Phase 1|
|Zhongda Hospital||Phase 4|
|Ohio State University Comprehensive Cancer Center||Phase 1|
Pharmacology for nilotinib hydrochloride
|Drug Class||Kinase Inhibitor |
|Mechanism of Action||Protein Kinase Inhibitors |
|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||Start Trial||Start Trial||Start Trial|
|Novartis||TASIGNA||nilotinib hydrochloride||CAPSULE;ORAL||022068-002||Jun 17, 2010||RX||Yes||No||Start Trial||Start Trial||Start Trial|
|Novartis||TASIGNA||nilotinib hydrochloride||CAPSULE;ORAL||022068-003||Mar 22, 2018||RX||Yes||No||Start Trial||Start Trial||Y||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
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