Dolutegravir (DTG) — Competitive Intelligence Brief

Dolutegravir (DTG) (Dolutegravir (DTG)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Integrase strand transfer inhibitor (INSTI). Area: Infectious Disease.

marketed Integrase strand transfer inhibitor (INSTI) HIV integrase Infectious Disease Small molecule

Target snapshot

Dolutegravir (DTG) (Dolutegravir (DTG)) — ViiV Healthcare. Dolutegravir inhibits HIV integrase, preventing the virus from inserting its genetic material into the host cell's DNA.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Dolutegravir (DTG) TARGET	Dolutegravir (DTG)	ViiV Healthcare	marketed	Integrase strand transfer inhibitor (INSTI)	HIV integrase
Cabotegravir Injectable Suspension	Cabotegravir Injectable Suspension	ViiV Healthcare	marketed	Integrase strand transfer inhibitor (INSTI)	HIV integrase
Dolutegravir / Lamivudine Pill	Dolutegravir / Lamivudine Pill	Charlotte-Paige Rolle, MD	marketed	Antiretroviral combination (INSTI + NRTI)	HIV integrase; HIV reverse transcriptase
Raltegravir, tenofovir/emtricitabine	Raltegravir, tenofovir/emtricitabine	University of California, San Francisco	marketed	Antiretroviral combination therapy (integrase inhibitor + nucleoside/nucleotide reverse transcriptase inhibitors)	HIV integrase, HIV reverse transcriptase
dolutegravir/abacavir/lamivudine	dolutegravir/abacavir/lamivudine	University College Dublin	marketed	Antiretroviral combination (INSTI + NRTIs)	HIV integrase, HIV reverse transcriptase
CAR	CAR	ViiV Healthcare	marketed	Antiretroviral combination therapy (INSTI + NNRTI)	HIV integrase and HIV reverse transcriptase
bictegravir/emtricitabine/tenofovir alafenamide	bictegravir/emtricitabine/tenofovir alafenamide	Midland Research Group, Inc.	marketed	Antiretroviral combination (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 (Integrase strand transfer inhibitor (INSTI) class)

1. ViiV Healthcare · 12 drugs in this class
2. National Institute of Allergy and Infectious Diseases (NIAID) · 5 drugs in this class
3. Merck Sharp & Dohme LLC · 5 drugs in this class
4. Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · 1 drug in this class
5. Germans Trias i Pujol Hospital · 1 drug in this class
6. Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux · 1 drug in this class
7. ANRS, Emerging Infectious Diseases · 1 drug in this class
8. Massachusetts General Hospital · 1 drug in this class
9. University of Colorado, Denver · 1 drug in this class
10. MU-JHU CARE · 1 drug in this class