AZILECT (nda021641)- (EQ 0.5MG BASE,EQ 1MG BASE)

Generic Name	RASAGILINE MESYLATE	Innovator	TEVA
Dosage	EQ 0.5MG BASE,EQ 1MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2027-Aug-27	NCE Excl Expiry	2011-May-16
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	AZILECT, a monoamine oxidase (MAO)-B inhibitor (MAOI), is indicated for the treatment of Parkinson’s disease

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
8	1	8

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
EQ 0.5MG BASE	**	**	Up	-	4
EQ 1MG BASE	**	**	Up	4	1

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	4

Manufacturing Details of AZILECT