METHOTREXATE PRESERVATIVE FREE (nda011719)- (EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML),EQ 500MG BASE/20ML (EQ 25MG BASE/ML),EQ 20MG BASE/2ML (EQ 10MG BASE/ML))

Generic Name	METHOTREXATE SODIUM	Innovator	HOSPIRA
Dosage	EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML),EQ 500MG BASE/20ML (EQ 25MG BASE/ML),EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
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	Methotrexate Injection is a folate analog metabolic inhibitor indicated for: • The following neoplastic diseases for the: o Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen o Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia o Treatment of adult and pediatric patients with non-Hodgkin lymphoma o Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen o Treatment of adults with breast cancer as part of a combination chemotherapy regimen o Treatment of adults with squamous cell carcinoma of the head and neck as single-agent o Treatment of adults with gestational trophoblastic neoplasia as part of a combination chemotherapy regimen • Treatment of adults with rheumatoid arthritis (RA). • Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). • Treatment of adults with severe psoriasis.

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
EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML)	**	**	-	-	-
EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	**	**	-	-	-
EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of METHOTREXATE PRESERVATIVE FREE