ABC/DTG/3TC FDC — Competitive Intelligence Brief

ABC/DTG/3TC FDC (ABC/DTG/3TC FDC) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Antiretroviral combination therapy (NRTI + INSTI). Area: Infectious Disease / Virology.

phase 3 Antiretroviral combination therapy (NRTI + INSTI) HIV reverse transcriptase, HIV integrase Infectious Disease / Virology Small molecule

Target snapshot

ABC/DTG/3TC FDC (ABC/DTG/3TC FDC) — ViiV Healthcare. A fixed-dose combination of three antiretroviral agents that inhibits HIV reverse transcriptase and integrase to suppress viral replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
ABC/DTG/3TC FDC TARGET	ABC/DTG/3TC FDC	ViiV Healthcare	phase 3	Antiretroviral combination therapy (NRTI + INSTI)	HIV reverse transcriptase, HIV integrase
Switch to Triumeq	Switch to Triumeq	McGill University Health Centre/Research Institute of the McGill University Health Centre	marketed	Antiretroviral combination therapy (NRTI + INSTI)	HIV reverse transcriptase, HIV integrase
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
Atripla or Stribild	Atripla or Stribild	Fred Hutchinson Cancer Center	marketed	Antiretroviral combination therapy (NRTI/NNRTI or INSTI-based)	HIV reverse transcriptase, HIV integrase
Tenofovir, lamivudine and efavirenz	Tenofovir, lamivudine and efavirenz	Centre for the AIDS Programme of Research in South Africa	marketed	Antiretroviral combination therapy (NRTI/NtRTI + NNRTI)	HIV reverse transcriptase, HIV integrase
Multiple Product PrEP Program	Multiple Product PrEP Program	University of Alabama at Birmingham	marketed	Antiretroviral combination therapy (nucleoside/nucleotide reverse transcriptase inhibitors)	HIV reverse transcriptase, HIV integrase
Nevirapine, FTC, and Tenofovir	Nevirapine, FTC, and Tenofovir	University of Maryland, Baltimore	marketed	Antiretroviral combination (NNRTI + NRTI + NtRI)	HIV reverse transcriptase, HIV integrase

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 (Antiretroviral combination therapy (NRTI + INSTI) class)

1. Fenway Community Health · 1 drug in this class
2. McGill University Health Centre/Research Institute of the McGill University Health Centre · 1 drug in this class
3. ViiV Healthcare · 1 drug in this class