ROZLYTREK (nda212725)- (100MG,200MG)

Generic Name	ENTRECTINIB	Innovator	GENENTECH INC
Dosage	100MG,200MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2038-Jul-18	NCE Excl Expiry	2024-Aug-15
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ROZLYTREK is a kinase inhibitor indicated for the treatment of: • Adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. • Adult and pediatric patients 12 years of age and older with solid tumors that: o have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion as detected by an FDA-approved test without a known acquired resistance mutation, o are metastatic or where surgical resection is likely to result in severe morbidity, and o have progressed following treatment or have no satisfactory alternative therapy.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
100MG	**	**	-	-	-
200MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of ROZLYTREK