AUBAGIO (nda202992)- (7MG,14MG)

Generic Name	TERIFLUNOMIDE	Innovator	SANOFI AVENTIS US
Dosage	7MG,14MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2034-Aug-04	NCE Excl Expiry	2017-Sep-12
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	AUBAGIO is a pyrimidine synthesis inhibitor indicated for the treatment of patients with relapsing forms of multiple sclerosis.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
12	0	10

Other Developers

Total Other Developers	10

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
7MG	**	**	-	-	7
14MG	**	**	-	5	1

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	4

Manufacturing Details of AUBAGIO