Lopinavir/ritonavir 4:1 — Competitive Intelligence Brief

Lopinavir/ritonavir 4:1 (Lopinavir/ritonavir 4:1) 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

Lopinavir/ritonavir 4:1 (Lopinavir/ritonavir 4:1) — Drugs for Neglected Diseases. Lopinavir and ritonavir are HIV protease inhibitors that block the viral protease enzyme, preventing the maturation of HIV particles and reducing viral replication.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Lopinavir/ritonavir 4:1 TARGET	Lopinavir/ritonavir 4:1	Drugs for Neglected Diseases	marketed	HIV protease inhibitor	HIV protease
Darunavir ritonavir	Darunavir ritonavir	St Stephens Aids Trust	marketed	HIV protease inhibitor (boosted)	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
Lopinavir/ritonavir simplification strategy	Lopinavir/ritonavir simplification strategy	Fundación Huésped	marketed	Protease inhibitor combination	HIV protease
First-line Antiretroviral Therapy	First-line Antiretroviral Therapy	UPECLIN HC FM Botucatu Unesp	marketed	Antiretroviral combination therapy (NRTI/NNRTI/PI/INSTI)	HIV reverse transcriptase, HIV protease, HIV integrase (depending on regimen components)
lopinavir/ritonavir and raltegravir	lopinavir/ritonavir and raltegravir	Saint Michael's Medical Center	marketed	Protease inhibitor (lopinavir/ritonavir) and integrase strand transfer inhibitor (raltegravir)	HIV protease (lopinavir/ritonavir) and HIV integrase (raltegravir)
atazanavir/raltegravir	atazanavir/raltegravir	Community Research Initiative of New England	marketed	Antiretroviral combination (protease inhibitor + integrase inhibitor)	HIV protease and HIV integrase

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