Dolutegravir Sodium Monohydrate — Competitive Intelligence Brief

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

phase 3 Integrase strand transfer inhibitor (INSTI) HIV integrase Infectious Disease Small molecule

Target snapshot

Dolutegravir Sodium Monohydrate (Dolutegravir Sodium Monohydrate) — University of Colorado, Denver. Dolutegravir sodium monohydrate inhibits HIV integrase, preventing the virus from integrating its genetic material into the host cell's DNA.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Dolutegravir Sodium Monohydrate TARGET	Dolutegravir Sodium Monohydrate	University of Colorado, Denver	phase 3	Integrase strand transfer inhibitor (INSTI)	HIV integrase
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
Dolutegravir, efavirenz, efavirenz/emtricitabine/tenofovir	Dolutegravir, efavirenz, efavirenz/emtricitabine/tenofovir	St Stephens Aids Trust	marketed	Antiretroviral agents (INSTI, NNRTI, NRTI/NtRTI)	HIV integrase (dolutegravir); HIV reverse transcriptase (efavirenz and combination); HIV entry (tenofovir/emtricitabine component)
GI265235	GI265235	ViiV Healthcare	marketed	HIV integrase strand transfer inhibitor (INSTI)	HIV integrase
Eviplera®	Eviplera®	St Stephens Aids Trust	marketed	Antiretroviral combination therapy (NNRTI + NRTI + NtRTI)	HIV reverse transcriptase, HIV integrase
DTG/ABC/3TC	DTG/ABC/3TC	Harvard School of Public Health (HSPH)	marketed	Antiretroviral combination therapy (integrase inhibitor + nucleoside reverse transcriptase inhibitors)	HIV integrase, HIV reverse transcriptase
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 (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