CABENUVA KIT (nda212888)- (400MG/2ML (200MG/ML);600MG/2ML (300MG/ML),600MG/3ML (200MG/ML);900MG/3ML (300MG/ML))

Generic Name	CABOTEGRAVIR; RILPIVIRINE	Innovator	VIIV HLTHCARE
Dosage	400MG/2ML (200MG/ML);600MG/2ML (300MG/ML),600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2031-Sep-15	NCE Excl Expiry	2026-Jan-21
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	CABENUVA, a 2-drug co-packaged product of cabotegravir, an HIV-1 integrase strand transfer inhibitor (INSTI), and rilpivirine, an HIV-1 nonnucleoside reverse transcriptase inhibitor (NNRTI), is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral 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	0	0

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)	**	**	-	-	-
600MG/3ML (200MG/ML);900MG/3ML (300MG/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of CABENUVA KIT