PEMETREXED FOR INJECTION (nda208297)- (1G,100MG,500MG)

Generic Name	PEMETREXED	Innovator	DR REDDYS LABS INC
Dosage	1G,100MG,500MG
ParaIV Filing	No	505(b)2 Filing	Yes
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	8

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
1G	**	**	-	-	-
100MG	**	**	-	-	-
500MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of PEMETREXED FOR INJECTION