Darunavir/Cobicistat (FDC) — Competitive Intelligence Brief

Darunavir/Cobicistat (FDC) (Darunavir/Cobicistat (FDC)) competitive landscape: 2 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: HIV protease inhibitor with pharmacokinetic booster. Area: Infectious Disease.

marketed HIV protease inhibitor with pharmacokinetic booster HIV protease; CYP3A4 Infectious Disease Small molecule

Target snapshot

Darunavir/Cobicistat (FDC) (Darunavir/Cobicistat (FDC)) — Janssen Scientific Affairs, LLC. Darunavir is a protease inhibitor that blocks HIV protease to prevent viral replication, while cobicistat is a boosting agent that inhibits CYP3A4 to increase darunavir levels.

Comparator set (2 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Darunavir/Cobicistat (FDC) TARGET	Darunavir/Cobicistat (FDC)	Janssen Scientific Affairs, LLC	marketed	HIV protease inhibitor with pharmacokinetic booster	HIV protease; CYP3A4
Atazanavir/Ritonavir + Famotidine	Atazanavir/Ritonavir + Famotidine	Bristol-Myers Squibb	marketed	HIV protease inhibitor (boosted) + H2-receptor antagonist	HIV protease; CYP3A4 (ritonavir); H2 receptor (famotidine)
Active comparator: DRV/cb	Active comparator: DRV/cb	Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud	marketed	HIV protease inhibitor with pharmacokinetic booster	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 (HIV protease inhibitor with pharmacokinetic booster class)

1. Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · 1 drug in this class
2. Janssen Scientific Affairs, LLC · 1 drug in this class