NEORAL (nda050715)- (25MG,50MG,100MG)

Generic Name	CYCLOSPORINE	Innovator	NOVARTIS
Dosage	25MG,50MG,100MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2014-Sep-26	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Neoral is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Neoral has been used in combination with azathioprine and corticosteroids. Neoral is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Neoral is indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy (e.g., PUVA, retinoids, or methotrexate) or in patients for whom other systemic therapies are contraindicated, or cannot be tolerated.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
6	0	5

Other Developers

Total Other Developers	7

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
25MG	**	**	Up	4	1
50MG	**	**	-	3	-
100MG	**	**	-	4	1

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	5

Manufacturing Details of NEORAL