DRV/COBI FDC — Competitive Intelligence Brief

DRV/COBI FDC (DRV/COBI FDC) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Protease inhibitor with pharmacokinetic booster. Area: Infectious Disease.

phase 3 Protease inhibitor with pharmacokinetic booster HIV protease Infectious Disease Small molecule

Target snapshot

DRV/COBI FDC (DRV/COBI FDC) — Janssen Research & Development, LLC. DRV/COBI is a fixed-dose combination of darunavir (a protease inhibitor) and cobicistat (a pharmacokinetic booster) that inhibits HIV protease to prevent viral replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
DRV/COBI FDC TARGET	DRV/COBI FDC	Janssen Research & Development, LLC	phase 3	Protease inhibitor with pharmacokinetic booster	HIV protease
lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine	lopinavir/ritonavir; nevirapine; Zidovudine; Lamivudine	University of British Columbia	marketed	Antiretroviral combination therapy (protease inhibitor + non-nucleoside reverse transcriptase inhibitor + nucleoside reverse transcriptase inhibitors)	HIV protease, HIV reverse transcriptase
lopinavir with ritonavir in 1:1 ratio	lopinavir with ritonavir in 1:1 ratio	Drugs for Neglected Diseases	marketed	HIV protease inhibitor	HIV protease
LPV/r + TDF/FTC or TDF/3TC	LPV/r + TDF/FTC or TDF/3TC	The HIV Netherlands Australia Thailand Research Collaboration	marketed	Antiretroviral combination therapy (protease inhibitor + nucleoside reverse transcriptase inhibitors)	HIV protease; HIV reverse transcriptase
LPV/r	LPV/r	The HIV Netherlands Australia Thailand Research Collaboration	marketed	Protease inhibitor (PI) combination	HIV protease
HIV therapy	HIV therapy	ViiV Healthcare	marketed	Antiretroviral agents (multiple classes: NRTIs, NNRTIs, PIs, INSTIs, entry inhibitors)	Multiple targets depending on specific agent (HIV reverse transcriptase, HIV protease, HIV integrase, CCR5 co-receptor, gp120/gp41 envelope proteins)
Fosamprenavir/ritonavir	Fosamprenavir/ritonavir	ViiV Healthcare	marketed	HIV 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 with pharmacokinetic booster class)

1. Janssen Research & Development, LLC · 1 drug in this class