darunavir (DRV, TMC114) — Competitive Intelligence Brief

darunavir (DRV, TMC114) (darunavir (DRV, TMC114)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Protease inhibitor. Area: Infectious diseases.

phase 3 Protease inhibitor HIV protease Infectious diseases Small molecule

Target snapshot

darunavir (DRV, TMC114) (darunavir (DRV, TMC114)) — Janssen-Cilag International NV. Darunavir is a protease inhibitor that blocks the protease enzyme in HIV, preventing viral replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
darunavir (DRV, TMC114) TARGET	darunavir (DRV, TMC114)	Janssen-Cilag International NV	phase 3	Protease inhibitor	HIV protease
Atazanavir, ritonavir, lamivudine	Atazanavir, ritonavir, lamivudine	Catholic University of the Sacred Heart	marketed	Antiretroviral combination (protease inhibitor + NRTI)	HIV protease, HIV reverse transcriptase
atazanavir/raltegravir	atazanavir/raltegravir	Community Research Initiative of New England	marketed	Antiretroviral combination (protease inhibitor + integrase inhibitor)	HIV protease and HIV integrase
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)
protease inhibitors	protease inhibitors	French National Agency for Research on AIDS and Viral Hepatitis	marketed	Protease inhibitor	HIV protease
Atazanavir + 2 NRTIs	Atazanavir + 2 NRTIs	Bristol-Myers Squibb	marketed	Protease inhibitor (PI) + nucleoside reverse transcriptase inhibitors (NRTIs)	HIV protease; HIV reverse transcriptase
raltegravir and atazanavir and ritonavir	raltegravir and atazanavir and ritonavir	Giovanni Di Perri	marketed	Antiretroviral combination therapy (INSTI + PI + booster)	HIV integrase, 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 class)

1. Pfizer · 4 drugs in this class
2. French National Agency for Research on AIDS and Viral Hepatitis · 4 drugs in this class
3. Merck Sharp & Dohme LLC · 2 drugs in this class
4. Christopher J. McLeod · 1 drug in this class
5. Hoffmann-La Roche · 1 drug in this class
6. Janssen R&D Ireland · 1 drug in this class
7. Janssen-Cilag International NV · 1 drug in this class
8. Johns Hopkins University · 1 drug in this class
9. Medical Research Council · 1 drug in this class
10. Pfizer Inc. · 1 drug in this class