PAXIL (nda020031)- (EQ 10MG BASE,EQ 20MG BASE,EQ 30MG BASE,EQ 50MG BASE,EQ 40MG BASE)

Generic Name	PAROXETINE HYDROCHLORIDE	Innovator	APOTEX
Dosage	EQ 10MG BASE,EQ 20MG BASE,EQ 30MG BASE,EQ 50MG BASE,EQ 40MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2019-Oct-23	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	PAXIL is a selective serotonin reuptake inhibitor (SSRI) indicated in adults for the treatment of: • Major Depressive Disorder (MDD) • Obsessive Compulsive Disorder (OCD) • Panic Disorder (PD) • Social Anxiety Disorder (SAD) • Generalized Anxiety Disorder (GAD) • Posttraumatic Stress Disorder (PTSD)

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
8	0	7

Other Developers

Total Other Developers	12

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 10MG BASE	**	**	-	-	7
EQ 20MG BASE	**	**	-	-	7
EQ 30MG BASE	**	**	-	-	7
EQ 50MG BASE	**	**	-	-	-
EQ 40MG BASE	**	**	-	-	7

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	7

Manufacturing Details of PAXIL