Darunavir (DRV) — Competitive Intelligence Brief

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

phase 3 HIV protease inhibitor HIV protease Infectious Disease Small molecule

Target snapshot

Darunavir (DRV) (Darunavir (DRV)) — Tibotec Pharmaceuticals, Ireland. 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) TARGET	Darunavir (DRV)	Tibotec Pharmaceuticals, Ireland	phase 3	HIV protease inhibitor	HIV protease
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)
Continue Ritonavir-boosted PI+Rosuvastatin	Continue Ritonavir-boosted PI+Rosuvastatin	Juan A. Arnaiz	marketed	Antiretroviral combination (protease inhibitor + statin)	HIV protease (PI component); HMG-CoA reductase (rosuvastatin component)
Combivir+Kaletra	Combivir+Kaletra	Hospital Clinic of Barcelona	marketed	Antiretroviral combination therapy (NRTI + protease inhibitor)	HIV reverse transcriptase and HIV protease
Combivir+Reyataz	Combivir+Reyataz	Hospital Clinic of Barcelona	marketed	Antiretroviral combination therapy (NRTI + protease inhibitor)	HIV reverse transcriptase; HIV protease
Symtuza® (TAF/FTC/DRV/c)	Symtuza® (TAF/FTC/DRV/c)	Fundacion SEIMC-GESIDA	marketed	Antiretroviral combination (NRTI/INSTI class with protease inhibitor)	HIV reverse transcriptase, HIV protease, CYP3A4
Atazanavir + 2 NRTIs	Atazanavir + 2 NRTIs	Bristol-Myers Squibb	marketed	Protease inhibitor (PI) + nucleoside reverse transcriptase inhibitors (NRTIs)	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