ZOLOFT (nda019839)- (EQ 50MG BASE,EQ 100MG BASE,EQ 150MG BASE,EQ 200MG BASE,EQ 25MG BASE)

Generic Name	SERTRALINE HYDROCHLORIDE	Innovator	VIATRIS
Dosage	EQ 50MG BASE,EQ 100MG BASE,EQ 150MG BASE,EQ 200MG BASE,EQ 25MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2013-Feb-13	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ZOLOFT is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of (1):  Major depressive disorder (MDD)  Obsessive-compulsive disorder (OCD)  Panic disorder (PD)  Post-traumatic stress disorder (PTSD)  Social anxiety disorder (SAD)  Premenstrual dysphoric disorder (PMDD)

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
11	1	9

Other Developers

Total Other Developers	13

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 50MG BASE	**	**	Up	-	7
EQ 100MG BASE	**	**	Up	-	7
EQ 150MG BASE	**	**	-	-	-
EQ 200MG BASE	**	**	-	-	-
EQ 25MG BASE	**	**	-	7	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	7

Manufacturing Details of ZOLOFT