EDURANT (nda202022)- (EQ 25MG BASE)

Generic Name	RILPIVIRINE HYDROCHLORIDE	Innovator	JANSSEN PRODS
Dosage	EQ 25MG BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2025-Oct-21	NCE Excl Expiry	2016-May-20
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	EDURANT is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 12 years of age and older and weighing at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL. EDURANT is indicated in combination with VOCABRIA (cabotegravir), for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

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
EQ 25MG BASE	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of EDURANT