CHANTIX (nda021928)- (EQ 0.5MG BASE,EQ 1MG BASE)

Generic Name	VARENICLINE TARTRATE	Innovator	PF PRISM CV
Dosage	EQ 0.5MG BASE,EQ 1MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2023-Feb-03	NCE Excl Expiry	2011-May-10
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	CHANTIX is a nicotinic receptor partial agonist indicated for use as an aid to smoking cessation treatment.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
14	2	13

Other Developers

Total Other Developers	30

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 0.5MG BASE	**	**	-	-	10
EQ 1MG BASE	**	**	-	-	10

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	9

Manufacturing Details of CHANTIX