Darunavir/Ritonavir (DRV/r) — Competitive Intelligence Brief

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

phase 3 Protease inhibitor (PI) HIV protease Infectious Disease / Virology Small molecule

Target snapshot

Darunavir/Ritonavir (DRV/r) (Darunavir/Ritonavir (DRV/r)) — Janssen-Cilag S.p.A.. Darunavir is a protease inhibitor that blocks HIV protease, preventing viral polyprotein cleavage and maturation, while ritonavir acts as a pharmacokinetic booster to increase darunavir levels.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Darunavir/Ritonavir (DRV/r) TARGET	Darunavir/Ritonavir (DRV/r)	Janssen-Cilag S.p.A.	phase 3	Protease inhibitor (PI)	HIV protease
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
Lopinavir/ritonavir + nevirapine	Lopinavir/ritonavir + nevirapine	Amsterdam UMC, location VUmc	marketed	Antiretroviral combination therapy (protease inhibitor + non-nucleoside reverse transcriptase inhibitor)	HIV protease; HIV reverse transcriptase
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
lopinavir/ritonavir and raltegravir	lopinavir/ritonavir and raltegravir	Saint Michael's Medical Center	marketed	Protease inhibitor (lopinavir/ritonavir) and integrase strand transfer inhibitor (raltegravir)	HIV protease (lopinavir/ritonavir) and HIV integrase (raltegravir)
protease inhibitors	protease inhibitors	French National Agency for Research on AIDS and Viral Hepatitis	marketed	Protease inhibitor	HIV protease

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 (Protease inhibitor (PI) class)

1. Janssen-Cilag S.p.A. · 1 drug in this class