Prezista® — Competitive Intelligence Brief

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

marketed HIV protease inhibitor HIV protease Infectious Disease Small molecule

Target snapshot

Prezista® (Prezista®) — Geropharm. Prezista (darunavir) is a protease inhibitor that blocks HIV protease, preventing the cleavage of viral polyproteins and inhibiting viral replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Prezista® TARGET	Prezista®	Geropharm	marketed	HIV protease inhibitor	HIV protease
Antiretroviral/Anti HIV	Antiretroviral/Anti HIV	MSD Pharmaceuticals LLC	marketed	Antiretroviral agent (multiple classes: NRTI, NNRTI, PI, INSTI, entry inhibitor)	HIV reverse transcriptase, HIV protease, HIV integrase, CCR5, or CXCR4 (depending on specific agent)
Atazanavir-Ritonavir/ Stavidine / Lamivudine	Atazanavir-Ritonavir/ Stavidine / Lamivudine	Bristol-Myers Squibb	marketed	Antiretroviral combination therapy (protease inhibitor + nucleoside reverse transcriptase inhibitors)	HIV protease, HIV reverse transcriptase
Lopinavir/ritonavir and ritonavir	Lopinavir/ritonavir and ritonavir	University of Miami	marketed	HIV protease inhibitor	HIV protease
Antiretroviral therapy	Antiretroviral therapy	ANRS, Emerging Infectious Diseases	marketed	Combination antiretroviral therapy (multiple classes: nucleoside/nucleotide reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, integrase strand transfer inhibitors, entry inhibitors)	HIV reverse transcriptase, HIV integrase, HIV protease, HIV envelope glycoproteins (gp120/gp41), CCR5 co-receptor
Nelfinavir and Omeprazole	Nelfinavir and Omeprazole	Pfizer	marketed	HIV protease inhibitor + proton pump inhibitor combination	HIV protease (nelfinavir); H+/K+-ATPase proton pump (omeprazole)
Standard Triple	Standard Triple	University of Alberta	marketed	Antiretroviral combination therapy	HIV reverse transcriptase, HIV protease (depending on formulation)

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