LOVENOX (PRESERVATIVE FREE) (nda020164)- (30MG/0.3ML (100MG/ML),40MG/0.4ML (100MG/ML),60MG/0.6ML (100MG/ML),80MG/0.8ML (100MG/ML),90MG/0.6ML (150MG/ML),100MG/ML (100MG/ML),120MG/0.8ML (150MG/ML),150MG/ML (150MG/ML))

Generic Name	ENOXAPARIN SODIUM	Innovator	SANOFI AVENTIS US
Dosage	30MG/0.3ML (100MG/ML),40MG/0.4ML (100MG/ML),60MG/0.6ML (100MG/ML),80MG/0.8ML (100MG/ML),90MG/0.6ML (150MG/ML),100MG/ML (100MG/ML),120MG/0.8ML (150MG/ML),150MG/ML (150MG/ML)
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2012-Feb-14	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Lovenox is a low molecular weight heparin [LMWH] indicated for: • Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness • Inpatient treatment of acute DVT with or without pulmonary embolism • Outpatient treatment of acute DVT without pulmonary embolism. • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction [MI] • Treatment of acute ST-segment elevation myocardial infarction [STEMI] managed medically or with subsequent percutaneous coronary intervention [PCI]

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
7	0	4

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
30MG/0.3ML (100MG/ML)	**	**	-	-	4
40MG/0.4ML (100MG/ML)	**	**	-	-	4
60MG/0.6ML (100MG/ML)	**	**	-	-	4
80MG/0.8ML (100MG/ML)	**	**	-	-	4
90MG/0.6ML (150MG/ML)	**	**	-	-	-
100MG/ML (100MG/ML)	**	**	-	-	7
120MG/0.8ML (150MG/ML)	**	**	-	3	1
150MG/ML (150MG/ML)	**	**	-	6	1

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	4

Manufacturing Details of LOVENOX (PRESERVATIVE FREE)