VYBRIQUE (NDA210858)- (EQ 25MG BASE,EQ 50MG BASE,EQ 75MG BASE,EQ 100MG BASE)

Generic Name	SILDENAFIL CITRATE	Innovator	IBSA
Dosage	EQ 25MG BASE,EQ 50MG BASE,EQ 75MG BASE,EQ 100MG BASE
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2033-Dec-16	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2028-Dec-16
GAIN Expiry	None	Drug Complexity	No
Indication	VYBRIQUE is a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED).

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 25MG BASE	**	**	-	-	-
EQ 50MG BASE	**	**	-	-	-
EQ 75MG BASE	**	**	-	-	-
EQ 100MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of VYBRIQUE