PLAVIX (nda020839)- (EQ 75MG BASE,EQ 300MG BASE)

Generic Name	CLOPIDOGREL BISULFATE	Innovator	SANOFI AVENTIS US
Dosage	EQ 75MG BASE,EQ 300MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2019-Dec-10	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Plavix is a P2Y12 platelet inhibitor indicated for: • Acute coronary syndrome – For patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), Plavix has been shown to reduce the rate of myocardial infarction (MI) and stroke. – For patients with ST-elevation myocardial infarction (STEMI), Plavix has been shown to reduce the rate of MI and stroke. • Recent MI, recent stroke, or established peripheral arterial disease. Plavix has been shown to reduce the rate of MI and stroke.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
18	0	16

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 75MG BASE	**	**	Up	-	9
EQ 300MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	9

Manufacturing Details of PLAVIX