ICLUSIG (nda203469)- (EQ 15MG BASE,EQ 45MG BASE,EQ 30MG BASE,EQ 10MG BASE)

Generic Name	PONATINIB HYDROCHLORIDE	Innovator	TAKEDA PHARMS USA
Dosage	EQ 15MG BASE,EQ 45MG BASE,EQ 30MG BASE,EQ 10MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2033-Dec-12	NCE Excl Expiry	2017-Dec-14
ODE Expiry	2019-Dec-14	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Iclusig is a kinase inhibitor indicated for the treatment of adult patients with: • Chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors. • Accelerated phase (AP) or blast phase (BP) CML or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other kinase inhibitors are indicated. • T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	1	0

Other Developers

Total Other Developers	5

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 15MG BASE	**	**	-	-	-
EQ 45MG BASE	**	**	-	-	-
EQ 30MG BASE	**	**	-	-	-
EQ 10MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of ICLUSIG