Bictegravir, emtricitabine, and tenofovir alafenamide — Competitive Intelligence Brief

Bictegravir, emtricitabine, and tenofovir alafenamide (Bictegravir, emtricitabine, and tenofovir alafenamide) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Antiretroviral combination (integrase inhibitor + nucleoside reverse transcriptase inhibitors). Area: Inf

marketed Antiretroviral combination (integrase inhibitor + nucleoside reverse transcriptase inhibitors) HIV integrase, HIV reverse transcriptase Infectious Disease / Virology Small molecule

Target snapshot

Bictegravir, emtricitabine, and tenofovir alafenamide (Bictegravir, emtricitabine, and tenofovir alafenamide) — CAN Community Health. This combination inhibits HIV reverse transcriptase and integrase to block viral replication and prevent the integration of viral DNA into the host genome.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Bictegravir, emtricitabine, and tenofovir alafenamide TARGET	Bictegravir, emtricitabine, and tenofovir alafenamide	CAN Community Health	marketed	Antiretroviral combination (integrase inhibitor + nucleoside reverse transcriptase inhibitors)	HIV integrase, HIV reverse transcriptase
ELV/COBI/FTC/TAF	ELV/COBI/FTC/TAF	Fundacion SEIMC-GESIDA	marketed	Antiretroviral combination therapy (integrase inhibitor + NRTI + NtRTI + pharmacokinetic booster)	HIV integrase, HIV reverse transcriptase
BIC/FTC/TAF	BIC/FTC/TAF	Prism Health North Texas	marketed	Antiretroviral combination therapy (integrase inhibitor + nucleoside reverse transcriptase inhibitors)	HIV integrase, HIV reverse transcriptase
Regimen：BIC+FTC+TAF	Regimen：BIC+FTC+TAF	National Center for AIDS/STD Control and Prevention, China CDC	marketed	Antiretroviral combination therapy (integrase inhibitor + nucleoside reverse transcriptase inhibitors)	HIV integrase, HIV reverse transcriptase
Genvoya Crushed Dose	Genvoya Crushed Dose	Johns Hopkins University	marketed	Antiretroviral combination (integrase inhibitor + NRTI + NtRTI + booster)	HIV integrase, HIV reverse transcriptase
Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill	Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill	Charlotte-Paige Rolle, MD	marketed	Antiretroviral combination (integrase inhibitor + nucleoside reverse transcriptase inhibitors)	HIV integrase, HIV reverse transcriptase
dolutegravir/abacavir/lamivudine	dolutegravir/abacavir/lamivudine	University College Dublin	marketed	Antiretroviral combination (INSTI + NRTIs)	HIV integrase, HIV reverse transcriptase

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Antiretroviral combination (integrase inhibitor + nucleoside reverse transcriptase inhibitors) class)

1. CAN Community Health · 1 drug in this class
2. Charlotte-Paige Rolle, MD · 1 drug in this class
3. Midland Research Group, Inc. · 1 drug in this class