LEVITRA (nda021400)- (EQ 5MG BASE,EQ 10MG BASE,EQ 2.5MG BASE,EQ 20MG BASE)

Generic Name	VARDENAFIL HYDROCHLORIDE	Innovator	BAYER HLTHCARE
Dosage	EQ 5MG BASE,EQ 10MG BASE,EQ 2.5MG BASE,EQ 20MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2027-Jul-23	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	LEVITRA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
5	0	5

Other Developers

Total Other Developers	2

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 5MG BASE	**	**	-	-	4
EQ 10MG BASE	**	**	-	-	5
EQ 2.5MG BASE	**	**	-	-	-
EQ 20MG BASE	**	**	-	5	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	1

Manufacturing Details of LEVITRA