Dolutegravir film-coated tablets — Competitive Intelligence Brief

Dolutegravir film-coated tablets (Dolutegravir film-coated tablets) 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 film-coated tablets (Dolutegravir film-coated tablets) — ViiV Healthcare. Dolutegravir 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 film-coated tablets TARGET	Dolutegravir film-coated tablets	ViiV Healthcare	phase 3	Integrase strand transfer inhibitor (INSTI)	HIV integrase
tenofovir, lamivudine, efavirenz	tenofovir, lamivudine, efavirenz	Bamrasnaradura Infectious Diseases Institute	marketed	Antiretroviral combination therapy (NRTI/NtRTI/NNRTI)	HIV reverse transcriptase, HIV integrase
Antiretroviral/Anti HIV	Antiretroviral/Anti HIV	MSD Pharmaceuticals LLC	marketed	Antiretroviral agent (multiple classes: NRTI, NNRTI, PI, INSTI, entry inhibitor)	HIV reverse transcriptase, HIV protease, HIV integrase, CCR5, or CXCR4 (depending on specific agent)
Sofosbuvir, Ribavirin, and Stribild	Sofosbuvir, Ribavirin, and Stribild	Saint Michael's Medical Center	marketed	Direct-acting antiviral (DAA) combination; antiretroviral combination	HCV NS5B RNA polymerase; HIV integrase; HIV reverse transcriptase
Long-acting Cabotegravir injection	Long-acting Cabotegravir injection	MU-JHU CARE	marketed	Integrase strand transfer inhibitor (INSTI)	HIV integrase
"Raltegravir" and "Zidovudine"	"Raltegravir" and "Zidovudine"	Universidad Peruana Cayetano Heredia	marketed	Antiretroviral combination (integrase inhibitor + nucleoside reverse transcriptase inhibitor)	HIV integrase (raltegravir); HIV reverse transcriptase (zidovudine)
Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill	Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill	Charlotte-Paige Rolle, MD	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