ARAVA (nda020905)- (10MG,20MG,100MG)

Generic Name	LEFLUNOMIDE	Innovator	SANOFI AVENTIS US
Dosage	10MG,20MG,100MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2014-Oct-21	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ARAVA is a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
9	0	9

Other Developers

Total Other Developers	4

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
10MG	**	**	-	-	7
20MG	**	**	-	-	7
100MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	8

Manufacturing Details of ARAVA