HEPARIN SODIUM IN PLASTIC CONTAINER (nda017029)- (1,000 UNITS/ML,5,000 UNITS/ML,10,000 UNITS/ML,20,000 UNITS/ML)

Generic Name	HEPARIN SODIUM	Innovator	FRESENIUS KABI USA
Dosage	1,000 UNITS/ML,5,000 UNITS/ML,10,000 UNITS/ML,20,000 UNITS/ML
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	HEPARIN SODIUM INJECTION is an anticoagulant indicated for • Prophylaxis and treatment of venous thrombosis and pulmonary embolism • Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease • Atrial fibrillation with embolization • Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation) • Prevention of clotting in arterial and cardiac surgery • Prophylaxis and treatment of peripheral arterial embolism • Use as an anticoagulant in blood transfusions, extracorporeal circulation, and dialysis procedures.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
9	0	8

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
1,000 UNITS/ML	**	**	-	-	-
5,000 UNITS/ML	**	**	-	-	6
10,000 UNITS/ML	**	**	-	-	-
20,000 UNITS/ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	7

Manufacturing Details of HEPARIN SODIUM IN PLASTIC CONTAINER