WIDAPLIK (NDA219423)- (EQ 1.25MG BASE;0.625MG;10MG,EQ 2.5MG BASE;1.25MG;20MG,EQ 5MG BASE;2.5MG;40MG)

Generic Name	AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN	Innovator	AZURITY
Dosage	EQ 1.25MG BASE;0.625MG;10MG,EQ 2.5MG BASE;1.25MG;20MG,EQ 5MG BASE;2.5MG;40MG
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2038-Jan-23	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2028-Jun-05
GAIN Expiry	None	Drug Complexity	No
Indication	WIDAPLIK is a combination tablet of telmisartan, an angiotensin II receptor blocker, amlodipine, a dihydropyridine calcium channel blocker and indapamide, a thiazide-like diuretic. Widaplik is indicated for the treatment of hypertension, including as initial treatment, to lower blood pressure. (1) Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

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
EQ 1.25MG BASE;0.625MG;10MG	**	**	-	-	-
EQ 2.5MG BASE;1.25MG;20MG	**	**	-	-	-
EQ 5MG BASE;2.5MG;40MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of WIDAPLIK