Dolutegravir film-coated dispersible tablets — Competitive Intelligence Brief

Dolutegravir film-coated dispersible tablets (Dolutegravir film-coated dispersible 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 dispersible tablets (Dolutegravir film-coated dispersible 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 dispersible tablets TARGET	Dolutegravir film-coated dispersible tablets	ViiV Healthcare	phase 3	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)
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
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
BIC/FTC/TAF	BIC/FTC/TAF	Prism Health North Texas	marketed	Antiretroviral combination therapy (integrase inhibitor + nucleoside reverse transcriptase inhibitors)	HIV integrase, HIV reverse transcriptase
Standard-of-care Antiretroviral therapy	Standard-of-care Antiretroviral therapy	Medical Research Council	marketed	Antiretroviral combination therapy (multiple classes: NRTI, NNRTI, PI, INSTI, entry inhibitors)	HIV reverse transcriptase, HIV protease, HIV integrase, HIV envelope glycoproteins (CCR5/CXCR4 co-receptors)
Long-acting Cabotegravir injection	Long-acting Cabotegravir injection	MU-JHU CARE	marketed	Integrase strand transfer inhibitor (INSTI)	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