PRESTALIA (nda205003)- (EQ 2.5MG BASE;3.5MG,EQ 5MG BASE;7MG,EQ 10MG BASE;14MG)

Generic Name	AMLODIPINE BESYLATE; PERINDOPRIL ARGININE	Innovator	ADHERA
Dosage	EQ 2.5MG BASE;3.5MG,EQ 5MG BASE;7MG,EQ 10MG BASE;14MG
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2029-Oct-05	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2018-Jan-21
GAIN Expiry	None	Drug Complexity	No
Indication	Prestalia is a combination of perindopril, an angiotensin converting enzyme inhibitor, and amlodipine, a dihydropyridine calcium channel blocker, indicated for the treatment of hypertension to lower blood pressure: • In patients not adequately controlled with monotherapy. • As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals. 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 2.5MG BASE;3.5MG	**	**	-	-	-
EQ 5MG BASE;7MG	**	**	-	-	-
EQ 10MG BASE;14MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of PRESTALIA