FTC/TDF FDC — Competitive Intelligence Brief

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

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

Target snapshot

FTC/TDF FDC (FTC/TDF FDC) — Janssen Sciences Ireland UC. FTC/TDF 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
FTC/TDF FDC TARGET	FTC/TDF FDC	Janssen Sciences Ireland UC	phase 3	Nucleoside/nucleotide reverse transcriptase inhibitor combination	HIV reverse transcriptase
Cabotegravir LA + Rilpivirine LA	Cabotegravir LA + Rilpivirine LA	Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia	marketed	Antiretroviral combination (INSTI + NNRTI)	HIV integrase and HIV reverse transcriptase
TAF/FTC FDC	TAF/FTC FDC	Janssen Scientific Affairs, LLC	marketed	Nucleoside reverse transcriptase inhibitor (NRTI) combination	HIV reverse transcriptase
FTC-TDF PrEP	FTC-TDF PrEP	University of Washington	marketed	Nucleoside/nucleotide reverse transcriptase inhibitor combination	HIV reverse transcriptase
Biktarvy 50/200/25 Tab	Biktarvy 50/200/25 Tab	Radboud University Medical Center	marketed	Antiretroviral combination (integrase inhibitor + nucleotide/nucleoside reverse transcriptase inhibitors)	HIV integrase, HIV reverse transcriptase
Bictegravir, emtricitabine, and tenofovir alafenamide	Bictegravir, emtricitabine, and tenofovir alafenamide	CAN Community Health	marketed	Antiretroviral combination (integrase inhibitor + nucleoside reverse transcriptase inhibitors)	HIV integrase, HIV reverse transcriptase
Antiretroviral therapy	Antiretroviral therapy	ANRS, Emerging Infectious Diseases	marketed	Combination antiretroviral therapy (multiple classes: nucleoside/nucleotide reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, integrase strand transfer inhibitors, entry inhibitors)	HIV reverse transcriptase, HIV integrase, HIV protease, HIV envelope glycoproteins (gp120/gp41), CCR5 co-receptor

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