emtricitabine [FTC]/tenofovir [TDF] — Competitive Intelligence Brief

emtricitabine [FTC]/tenofovir [TDF] (emtricitabine [FTC]/tenofovir [TDF]) 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

emtricitabine [FTC]/tenofovir [TDF] (emtricitabine [FTC]/tenofovir [TDF]) — Tibotec, Inc. This combination of two nucleoside reverse transcriptase inhibitors (NRTIs) blocks HIV reverse transcriptase to prevent viral replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
emtricitabine [FTC]/tenofovir [TDF] TARGET	emtricitabine [FTC]/tenofovir [TDF]	Tibotec, Inc	marketed	Nucleoside reverse transcriptase inhibitor (NRTI) combination	HIV reverse transcriptase
"Raltegravir" and "Zidovudine"	"Raltegravir" and "Zidovudine"	Universidad Peruana Cayetano Heredia	marketed	Antiretroviral combination (integrase inhibitor + nucleoside reverse transcriptase inhibitor)	HIV integrase (raltegravir); HIV reverse transcriptase (zidovudine)
Sofosbuvir, Ribavirin, and Stribild	Sofosbuvir, Ribavirin, and Stribild	Saint Michael's Medical Center	marketed	Direct-acting antiviral (DAA) combination; antiretroviral combination	HCV NS5B RNA polymerase; HIV integrase; HIV reverse transcriptase
Abacavir sulfate, Lamivudine and Zidovudine	Abacavir sulfate, Lamivudine and Zidovudine	National Institute of Allergy and Infectious Diseases (NIAID)	marketed	Nucleoside reverse transcriptase inhibitor (NRTI) combination	HIV reverse transcriptase
TDF/3TC/EFV or DTG or NVP	TDF/3TC/EFV or DTG or NVP	MU-JHU CARE	marketed	Antiretroviral combination therapy (NRTI + NNRTI or INSTI)	HIV reverse transcriptase, HIV integrase
Vaginal TFV Gel	Vaginal TFV Gel	University of Washington	marketed	Nucleotide reverse transcriptase inhibitor (microbicide)	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

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