COZAAR (nda020386)- (25MG,50MG,100MG)

Generic Name	LOSARTAN POTASSIUM	Innovator	ORGANON
Dosage	25MG,50MG,100MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2014-Sep-04	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	COZAAR is an angiotensin II receptor blocker (ARB) indicated for: • Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. • Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. • Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
20	0	15

Other Developers

Total Other Developers	17

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
25MG	**	**	Up	-	11
50MG	**	**	Up	-	12
100MG	**	**	Up	-	11

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	14

Manufacturing Details of COZAAR