lopinavir/ritonavir soft gel capsule — Competitive Intelligence Brief

lopinavir/ritonavir soft gel capsule (lopinavir/ritonavir soft gel capsule) 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

lopinavir/ritonavir soft gel capsule (lopinavir/ritonavir soft gel capsule) — Bamrasnaradura Infectious Diseases Institute. Lopinavir/ritonavir is a combination of two antiretroviral drugs that inhibit the protease enzyme in HIV, preventing viral replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
lopinavir/ritonavir soft gel capsule TARGET	lopinavir/ritonavir soft gel capsule	Bamrasnaradura Infectious Diseases Institute	phase 3	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
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)
lopinavir with ritonavir in 1:1 ratio	lopinavir with ritonavir in 1:1 ratio	Drugs for Neglected Diseases	marketed	HIV protease inhibitor	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
LPV/r	LPV/r	The HIV Netherlands Australia Thailand Research Collaboration	marketed	Protease inhibitor (PI) combination	HIV protease
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 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