EMSAM (nda021336)- (6MG/24HR,9MG/24HR,12MG/24HR)

Generic Name	SELEGILINE	Innovator	SOMERSET
Dosage	6MG/24HR,9MG/24HR,12MG/24HR
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2018-Jun-12	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	EMSAM ® (selegiline transdermal system) is a monoamine oxidase inhibitor (MAOI) indicated for the treatment of major depressive disorder (MDD).

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
6MG/24HR	**	**	-	-	-
9MG/24HR	**	**	-	-	-
12MG/24HR	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of EMSAM