TAF/FTC FDC — Competitive Intelligence Brief

TAF/FTC FDC (TAF/FTC FDC) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nucleoside reverse transcriptase inhibitor (NRTI) combination. Area: Infectious Disease / Virology.

marketed Nucleoside reverse transcriptase inhibitor (NRTI) combination HIV reverse transcriptase Infectious Disease / Virology Small molecule

Target snapshot

TAF/FTC FDC (TAF/FTC FDC) — Janssen Scientific Affairs, LLC. TAF/FTC is a fixed-dose combination of two nucleoside reverse transcriptase inhibitors that block HIV reverse transcriptase to prevent viral replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
TAF/FTC FDC TARGET	TAF/FTC FDC	Janssen Scientific Affairs, LLC	marketed	Nucleoside reverse transcriptase inhibitor (NRTI) combination	HIV reverse transcriptase
Atazanavir + Ritonavir + 2 NRTIs	Atazanavir + Ritonavir + 2 NRTIs	Bristol-Myers Squibb	marketed	Antiretroviral combination therapy (protease inhibitor + pharmacokinetic booster + nucleoside reverse transcriptase inhibitors)	HIV protease, HIV reverse transcriptase, cytochrome P450 (CYP3A4)
AZT+3TC+ABV (Trizivir)	AZT+3TC+ABV (Trizivir)	Fundacion SEIMC-GESIDA	marketed	Nucleoside reverse transcriptase inhibitor (NRTI) combination	HIV reverse transcriptase
Switch to B/F/TAF	Switch to B/F/TAF	University of Nairobi	marketed	Antiretroviral combination (integrase inhibitor + nucleoside/nucleotide reverse transcriptase inhibitors)	HIV integrase, HIV reverse transcriptase
Dolutegravir/Lamivudine	Dolutegravir/Lamivudine	Saint Michael's Medical Center	marketed	Antiretroviral combination (INSTI + NRTI)	HIV integrase; HIV reverse transcriptase
Efavirenz (EFV)	Efavirenz (EFV)	Janssen-Cilag S.p.A.	marketed	Non-nucleoside reverse transcriptase inhibitor (NNRTI)	HIV reverse transcriptase
Twice-daily ABC+3TC	Twice-daily ABC+3TC	Medical Research Council	marketed	Nucleoside reverse transcriptase inhibitor (NRTI) combination	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 (Nucleoside reverse transcriptase inhibitor (NRTI) combination class)

1. Medical Research Council · 2 drugs in this class
2. Bristol-Myers Squibb · 1 drug in this class
3. Fundacion SEIMC-GESIDA · 1 drug in this class
4. GlaxoSmithKline · 1 drug in this class
5. Janssen Scientific Affairs, LLC · 1 drug in this class
6. Merck Sharp & Dohme LLC · 1 drug in this class
7. National Institute of Allergy and Infectious Diseases (NIAID) · 1 drug in this class
8. Tibotec, Inc · 1 drug in this class
9. University of North Carolina, Chapel Hill · 1 drug in this class
10. Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · 1 drug in this class