Apomivir® — Competitive Intelligence Brief

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

phase 2 HIV protease inhibitor HIV protease Infectious Disease Small molecule

Target snapshot

Apomivir® (Apomivir®) — Far East Bio-Tec Co., Ltd. Apomivir is an HIV protease inhibitor that blocks 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
Apomivir® TARGET	Apomivir®	Far East Bio-Tec Co., Ltd	phase 2	HIV protease inhibitor	HIV protease
Lopinavir/ritonavir (Kaletra)	Lopinavir/ritonavir (Kaletra)	Abbott	marketed	HIV protease inhibitor	HIV protease
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)
Switch to DRV/cobicistat + 3TC	Switch to DRV/cobicistat + 3TC	Hospitales Universitarios Virgen del Rocío	marketed	Antiretroviral combination therapy (protease inhibitor + pharmacokinetic booster + nucleoside reverse transcriptase inhibitor)	HIV protease, CYP3A4, HIV reverse transcriptase
Atazanavir + Ritonavir + 2 NRTIs	Atazanavir + Ritonavir + 2 NRTIs	Bristol-Myers Squibb	marketed	Antiretroviral combination therapy (protease inhibitor + pharmacokinetic booster + nucleoside reverse transcriptase inhibitors)	HIV protease, HIV reverse transcriptase, cytochrome P450 (CYP3A4)
Reyataz + Norvir + Truvada	Reyataz + Norvir + Truvada	ViiV Healthcare	marketed	Antiretroviral combination therapy (protease inhibitor + nucleoside reverse transcriptase inhibitors)	HIV protease, HIV reverse transcriptase
Atazanavir + 2 NRTIs	Atazanavir + 2 NRTIs	Bristol-Myers Squibb	marketed	Protease inhibitor (PI) + nucleoside reverse transcriptase inhibitors (NRTIs)	HIV protease; HIV reverse transcriptase

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