WELLCOVORIN (NDA018342)- (EQ 5MG BASE,EQ 25MG BASE)

Generic Name	LEUCOVORIN CALCIUM	Innovator	GLAXOSMITHKLINE
Dosage	EQ 5MG BASE,EQ 25MG BASE
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	Leucovorin calcium rescue is indicated after high dose methotrexate therapy in osteosarcoma. Leucovorin calcium is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists. Leucovorin calcium is indicated in the treatment of megaloblastic anemias due to folic acid deficiency when oral therapy is not feasible. Leucovorin is also indicated for use in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. Leucovorin should not be mixed in the same infusion as 5-fluorouracil because a precipitate may form.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
7	0	7

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	Yes

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 5MG BASE	**	**	-	-	5
EQ 25MG BASE	**	**	-	-	5

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	7

Manufacturing Details of WELLCOVORIN