Darunavir (DRV/r) — Competitive Intelligence Brief

Darunavir (DRV/r) (Darunavir (DRV/r)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: HIV protease inhibitor. Area: Infectious Disease.

marketed HIV protease inhibitor HIV protease Infectious Disease Small molecule

Target snapshot

Darunavir (DRV/r) (Darunavir (DRV/r)) — Community Research Initiative of New England. Darunavir is a protease inhibitor that blocks HIV protease, preventing the cleavage of viral polyproteins and maturation of infectious HIV particles.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Darunavir (DRV/r) TARGET	Darunavir (DRV/r)	Community Research Initiative of New England	marketed	HIV protease inhibitor	HIV protease
Atazanavir + Ritonavir + 2 NRTIs	Atazanavir + Ritonavir + 2 NRTIs	Bristol-Myers Squibb	marketed	Antiretroviral combination therapy (protease inhibitor + pharmacokinetic booster + nucleoside reverse transcriptase inhibitors)	HIV protease, HIV reverse transcriptase, cytochrome P450 (CYP3A4)
AZT+3TC+IDV+RTV	AZT+3TC+IDV+RTV	Hospital Clinic of Barcelona	marketed	Antiretroviral combination therapy (NRTI + PI)	HIV reverse transcriptase; HIV protease
Reyataz + Epzicom	Reyataz + Epzicom	ViiV Healthcare	marketed	Antiretroviral combination (protease inhibitor + nucleoside reverse transcriptase inhibitors)	HIV protease; HIV reverse transcriptase
PEP	PEP	Christopher J. McLeod	marketed	Protease inhibitor	HIV protease
Switch to DRV/cobicistat + 3TC	Switch to DRV/cobicistat + 3TC	Hospitales Universitarios Virgen del Rocío	marketed	Antiretroviral combination therapy (protease inhibitor + pharmacokinetic booster + nucleoside reverse transcriptase inhibitor)	HIV protease, CYP3A4, HIV reverse transcriptase
atazanavir/tenofovir/emtricitabine	atazanavir/tenofovir/emtricitabine	Community Research Initiative of New England	marketed	Antiretroviral combination (protease inhibitor + nucleoside/nucleotide reverse transcriptase inhibitors)	HIV protease, 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 (HIV protease inhibitor class)

1. Bristol-Myers Squibb · 5 drugs in this class
2. ViiV Healthcare · 3 drugs in this class
3. GlaxoSmithKline · 2 drugs in this class
4. Drugs for Neglected Diseases · 2 drugs in this class
5. Germans Trias i Pujol Hospital · 2 drugs in this class
6. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · 1 drug in this class
7. DualityBio Inc. · 1 drug in this class
8. French National Agency for Research on AIDS and Viral Hepatitis · 1 drug in this class
9. Far East Bio-Tec Co., Ltd · 1 drug in this class
10. Community Research Initiative of New England · 1 drug in this class