DEFENCATH (NDA214520)- (3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML),5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML))

Generic Name	HEPARIN SODIUM; TAUROLIDINE	Innovator	CORMEDIX
Dosage	3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML),5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2042-Apr-15	NCE Excl Expiry	2028-Nov-15
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	DEFENCATH is a combination of taurolidine, a thiadiazinane antimicrobial, and heparin, an anti-coagulant, indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

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
3,000 UNITS/3ML (1,000 UNITS/ML);40.5MG/3ML (13.5MG/ML)	**	**	-	-	-
5,000 UNITS/5ML (1,000 UNITS/ML);67.5MG/5ML (13.5MG/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of DEFENCATH