TWYNSTA (nda022401)- (EQ 5MG BASE;40MG,EQ 10MG BASE;40MG,EQ 5MG BASE;80MG,EQ 10MG BASE;80MG)

Generic Name	AMLODIPINE BESYLATE; TELMISARTAN	Innovator	BOEHRINGER INGELHEIM
Dosage	EQ 5MG BASE;40MG,EQ 10MG BASE;40MG,EQ 5MG BASE;80MG,EQ 10MG BASE;80MG
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2014-Jan-07	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	TWYNSTA is an angiotensin II receptor blocker (ARB) and a dihydropyridine calcium channel blocker (DHP-CCB) combination product indicated for the treatment of hypertension alone or with other antihypertensive agents to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. • TWYNSTA tablets are indicated as initial therapy in patients likely to need multiple antihypertensive agents to achieve their blood pressure goals.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
3	0	3

Other Developers

Total Other Developers	5

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 5MG BASE;40MG	**	**	-	-	1
EQ 10MG BASE;40MG	**	**	-	-	1
EQ 5MG BASE;80MG	**	**	-	-	1
EQ 10MG BASE;80MG	**	**	-	1	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	3

Manufacturing Details of TWYNSTA