DUTREBIS (nda206510)- (150MG;EQ 300MG BASE)

Generic Name	LAMIVUDINE; RALTEGRAVIR POTASSIUM	Innovator	MERCK SHARP DOHME
Dosage	150MG;EQ 300MG BASE
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2029-Sep-11	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	DUTREBIS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

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
150MG;EQ 300MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of DUTREBIS