VYKOURA (NDA220406)- (EQ 50MG BASE/5ML (EQ 10MG BASE/ML),EQ 350MG BASE/35ML (EQ 10MG BASE/ML),EQ 500MG BASE/50ML (EQ 10MG BASE/ML))

Generic Name	LEUCOVORIN CALCIUM	Innovator	AVYXA HOLDINGS
Dosage	EQ 50MG BASE/5ML (EQ 10MG BASE/ML),EQ 350MG BASE/35ML (EQ 10MG BASE/ML),EQ 500MG BASE/50ML (EQ 10MG BASE/ML)
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	VYKOURA is a folate analog indicated for: • Rescue after high-dose methotrexate therapy in adult and pediatric patients. • Reducing the toxicity of o methotrexate in adult and pediatric patients with impaired methotrexate elimination or o folic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose in adult and pediatric patients.• Treatment of megaloblastic anemias due to folic acid deficiency in adult and pediatric patients when oral therapy is not feasible. • Treatment of patients with metastatic colorectal cancer in combination with 5-fluorouracil.

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 50MG BASE/5ML (EQ 10MG BASE/ML)	**	**	-	-	-
EQ 350MG BASE/35ML (EQ 10MG BASE/ML)	**	**	-	-	-
EQ 500MG BASE/50ML (EQ 10MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of VYKOURA