Nilotinib hydrochloride - Generic Drug Details

What are the generic sources for nilotinib hydrochloride and what is the scope of 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.

Nilotinib hydrochloride has two hundred and seventy-six patent family members in fifty-one countries.

There are seven drug master file entries for nilotinib hydrochloride. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for nilotinib hydrochloride

International Patents:	276
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	199
Patent Applications:	286
Formulation / Manufacturing:	see details
DailyMed Link:	nilotinib hydrochloride at DailyMed

Recent Clinical Trials for nilotinib hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
H. Jean Khoury Cure CML Consortium	Phase 2
Sun Pharmaceuticals Industries Limited	Phase 3
KeifeRx, LLC	Phase 3

See all nilotinib hydrochloride clinical trials

Generic filers with tentative approvals for NILOTINIB HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 200MG BASE	CAPSULE;ORAL
		EQ 150MG BASE	CAPSULE;ORAL
		EQ 50MG BASE	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for nilotinib hydrochloride

Drug Class	Kinase Inhibitor
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

Paragraph IV (Patent) Challenges for NILOTINIB HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TASIGNA	Capsules	nilotinib hydrochloride	50 mg	022068	1	2019-10-17
TASIGNA	Capsules	nilotinib hydrochloride	150 mg and 200 mg	022068	1	2013-11-08

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					Y
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-001	Oct 29, 2007		RX	Yes	Yes					Y
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-001	Oct 29, 2007		RX	Yes	Yes
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-001	Oct 29, 2007		RX	Yes	Yes					Y
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					Y

International Patents for nilotinib hydrochloride

Country	Patent Number	Title	Estimated Expiration
Japan	2010504942
Russian Federation	2009115782	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ НИЛОТИНИБ ИЛИ ЕГО СОЛЬ
Chile	2012001270	Compuesto 4-metil-n-[3-(4-metil-1h-imidazol-1-il)-5-(trifluorometil)fenil]-3-[(4-piridin-3-ilpirimidin-2-il)amino] benzamida (nilotinib) para el tratamiento de un trastorno proliferativo u otras condiciones mediadas por quinasa bcr-abl, c-kit, ddr1, ddr2 o pdgf-r, administrado oralmente dispersado en una compota de manzana.
New Zealand	564182	Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide
Malaysia	169956	METHOD OF TREATING PROLIFERATIVE DISORDERS AND OTHER PATHOLOGICAL CONDITIONS MEDIATED BY BCR-ABL, C-KIT, DDR1, DDR2 OR PDGF-R KINASE ACTIVITY
Cyprus	1108813