PEMETREXED DITROMETHAMINE (nda208746)- (EQ 100MG BASE/VIAL,EQ 500MG BASE/VIAL,EQ 1GM BASE/VIAL)

Generic Name	PEMETREXED DITROMETHAMINE	Innovator	HOSPIRA
Dosage	EQ 100MG BASE/VIAL,EQ 500MG BASE/VIAL,EQ 1GM BASE/VIAL
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Pemetrexed for Injection is a folate analog metabolic inhibitor indicated: • In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). • As a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. • As a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy.

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
EQ 100MG BASE/VIAL	**	**	-	-	-
EQ 500MG BASE/VIAL	**	**	-	-	-
EQ 1GM BASE/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of PEMETREXED DITROMETHAMINE