ODEFSEY (nda208351)- (200MG;EQ 25MG BASE;EQ 25MG BASE)

Generic Name	EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE	Innovator	GILEAD SCIENCES INC
Dosage	200MG;EQ 25MG BASE;EQ 25MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2033-Feb-15	NCE Excl Expiry	2020-Nov-05
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ODEFSEY is a three-drug combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), and rilpivirine (RPV), a non-nucleoside reverse transcriptase inhibitor (NNRTI), and is indicated as a complete regimen for the treatment of HIV-1 infection in patients weighing at least 35kg as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies per mL; or to replace a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of ODEFSEY.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	1	0

Other Developers

Total Other Developers	10

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
200MG;EQ 25MG BASE;EQ 25MG BASE	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of ODEFSEY