lopinavir or efavirenz — Competitive Intelligence Brief

lopinavir or efavirenz (lopinavir or efavirenz) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Protease inhibitor. Area: Infectious disease.

phase 3 Protease inhibitor HIV protease Infectious disease Small molecule

Target snapshot

lopinavir or efavirenz (lopinavir or efavirenz) — French National Agency for Research on AIDS and Viral Hepatitis. Lopinavir is a protease inhibitor that blocks the protease enzyme, preventing viral replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
lopinavir or efavirenz TARGET	lopinavir or efavirenz	French National Agency for Research on AIDS and Viral Hepatitis	phase 3	Protease inhibitor	HIV protease
Fosamprenavir/ritonavir	Fosamprenavir/ritonavir	ViiV Healthcare	marketed	HIV protease inhibitor	HIV protease
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
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)
Symtuza® (TAF/FTC/DRV/c)	Symtuza® (TAF/FTC/DRV/c)	Fundacion SEIMC-GESIDA	marketed	Antiretroviral combination (NRTI/INSTI class with protease inhibitor)	HIV reverse transcriptase, HIV protease, CYP3A4
continue on current dual boosted PI	continue on current dual boosted PI	Community Research Initiative of New England	marketed	Protease inhibitor (PI) combination with pharmacokinetic booster	HIV protease
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 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