INTEGRILIN (nda020718)- (2MG/ML,75MG/100ML)

Generic Name	EPTIFIBATIDE	Innovator	MSD SUB MERCK
Dosage	2MG/ML,75MG/100ML
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2015-Sep-15	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	INTEGRILIN is a platelet aggregation inhibitor indicated for: • Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) • Treatment of patients undergoing PCI (including intracoronary stenting).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
10	0	7

Other Developers

Total Other Developers	2

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
2MG/ML	**	**	-	-	-
75MG/100ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	6

Manufacturing Details of INTEGRILIN