VALTREX (nda020487)- (EQ 500MG BASE,EQ 1GM BASE)

Generic Name	VALACYCLOVIR HYDROCHLORIDE	Innovator	GLAXOSMITHKLINE
Dosage	EQ 500MG BASE,EQ 1GM BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2016-Jul-19	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	VALTREX is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: *Adult Patients: • Cold Sores (Herpes Labialis) • Genital Herpes • Treatment in immunocompetent patients (initial or recurrent episode) • Suppression in immunocompetent or HIV-1−infected patients • Reduction of transmission • Herpes Zoster *Pediatric Patients: • Cold Sores (Herpes Labialis) • Chickenpox

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
12	0	10

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 500MG BASE	**	**	Up	-	7
EQ 1GM BASE	**	**	-	-	7

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	8

Manufacturing Details of VALTREX