JAKAFI (nda202192)- (EQ 5MG BASE,EQ 10MG BASE,EQ 15MG BASE,EQ 20MG BASE,EQ 25MG BASE)

Generic Name	RUXOLITINIB PHOSPHATE	Innovator	INCYTE CORP
Dosage	EQ 5MG BASE,EQ 10MG BASE,EQ 15MG BASE,EQ 20MG BASE,EQ 25MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2028-Dec-12	NCE Excl Expiry	2016-Nov-16
ODE Expiry	2018-Nov-16	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Jakafi is a kinase inhibitor indicated for treatment of: • intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis in adults. • polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. • steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older. • chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	15

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 5MG BASE	**	**	-	-	-
EQ 10MG BASE	**	**	-	-	-
EQ 15MG BASE	**	**	-	-	-
EQ 20MG BASE	**	**	-	-	-
EQ 25MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of JAKAFI