tenofovir disproxil fumarate/emtricitabine — Competitive Intelligence Brief

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

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

Target snapshot

tenofovir disproxil fumarate/emtricitabine (tenofovir disproxil fumarate/emtricitabine) — Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. Tenofovir disproxil fumarate 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 disproxil fumarate/emtricitabine TARGET	tenofovir disproxil fumarate/emtricitabine	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	marketed	Nucleoside/nucleotide reverse transcriptase inhibitor combination	HIV reverse transcriptase
Darunavir / Ritonavir + Tenofovir / Emtricitabine	Darunavir / Ritonavir + Tenofovir / Emtricitabine	Juan A. Arnaiz	marketed	Antiretroviral combination (protease inhibitor + nucleoside reverse transcriptase inhibitors)	HIV protease, HIV reverse transcriptase
All licensed antiretroviral medications	All licensed antiretroviral medications	University of Minnesota	marketed	Antiretroviral agents (multiple classes: NRTIs, NNRTIs, PIs, INSTIs, entry inhibitors)	Multiple (HIV reverse transcriptase, HIV protease, HIV integrase, CCR5, CXCR4, gp120/gp41)
3TC	3TC	Avexa	marketed	Nucleoside reverse transcriptase inhibitor (NRTI)	HIV reverse transcriptase; hepatitis B polymerase
Truvada Pill	Truvada Pill	University of North Carolina, Chapel Hill	marketed	Nucleoside reverse transcriptase inhibitor (NRTI) combination	HIV reverse transcriptase
Immediate switch to TDF/FTC/RPV	Immediate switch to TDF/FTC/RPV	Azienda Ospedaliera San Gerardo di Monza	marketed	Antiretroviral combination therapy (NRTI/NNRTI)	HIV reverse transcriptase, HIV integrase
Lamivudine/Zidovudine	Lamivudine/Zidovudine	Bristol-Myers Squibb	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/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