PEMFEXY (nda209472)- (500MG/20ML (25MG/ML))

Generic Name	PEMETREXED	Innovator	EAGLE PHARMS
Dosage	500MG/20ML (25MG/ML)
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2036-Feb-19	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	PEMFEXY is a folate analog metabolic inhibitor indicated for: • 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	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
500MG/20ML (25MG/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of PEMFEXY