Tenofovir/emtricitabine FDC — Competitive Intelligence Brief

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

phase 3 Nucleoside/nucleotide reverse transcriptase inhibitor combination HIV reverse transcriptase Infectious Disease / Virology Small molecule

Target snapshot

Tenofovir/emtricitabine FDC (Tenofovir/emtricitabine FDC) — ViiV Healthcare. Tenofovir and emtricitabine are nucleotide/nucleoside reverse transcriptase inhibitors that block HIV replication by inhibiting the enzyme responsible for converting viral RNA into DNA.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Tenofovir/emtricitabine FDC TARGET	Tenofovir/emtricitabine FDC	ViiV Healthcare	phase 3	Nucleoside/nucleotide reverse transcriptase inhibitor combination	HIV reverse transcriptase
Atazanavir/ Stavidine / Lamivudine	Atazanavir/ Stavidine / Lamivudine	Bristol-Myers Squibb	marketed	Antiretroviral combination therapy (protease inhibitor + nucleoside reverse transcriptase inhibitors)	HIV protease, HIV reverse transcriptase
Emtricitabine / Tenofovir	Emtricitabine / Tenofovir	The Miriam Hospital	marketed	Nucleoside/nucleotide reverse transcriptase inhibitor (NRTI/NtRTI) combination	HIV reverse transcriptase
Abacavir/Lamivudine	Abacavir/Lamivudine	GlaxoSmithKline	marketed	Nucleoside reverse transcriptase inhibitor (NRTI)	HIV reverse transcriptase
Doravirine + tenofovir DF + lamivudine	Doravirine + tenofovir DF + lamivudine	Instituto Mexicano del Seguro Social	marketed	Antiretroviral combination (NNRTI + NRTIs)	HIV reverse transcriptase
Switch to DTG + 3TC	Switch to DTG + 3TC	Hospitales Universitarios Virgen del Rocío	marketed	Antiretroviral combination (INSTI + NRTI)	HIV integrase; HIV reverse transcriptase
DOR/3TC/TDF	DOR/3TC/TDF	Prism Health North Texas	marketed	Antiretroviral combination therapy (NNRTI + NRTI + NtRTI)	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/nucleotide reverse transcriptase inhibitor combination class)

1. ViiV Healthcare · 2 drugs in this class
2. Brigham and Women's Hospital · 1 drug in this class
3. Fundacion IDEAA · 1 drug in this class
4. Janssen Sciences Ireland UC · 1 drug in this class
5. Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · 1 drug in this class
6. National Institute of Allergy and Infectious Diseases (NIAID) · 1 drug in this class
7. University of Chicago · 1 drug in this class
8. University of Washington · 1 drug in this class
9. Merck Sharp & Dohme LLC · 1 drug in this class