LEXIVA (nda021548)- (EQ 700MG BASE)

Generic Name	FOSAMPRENAVIR CALCIUM	Innovator	VIIV HLTHCARE
Dosage	EQ 700MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2020-Jan-15	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	LEXIVA is an HIV protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
2	1	2

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 700MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	2

Manufacturing Details of LEXIVA