ritonavir-boosted fosamprenavir — Competitive Intelligence Brief

ritonavir-boosted fosamprenavir (ritonavir-boosted fosamprenavir) 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

ritonavir-boosted fosamprenavir (ritonavir-boosted fosamprenavir) — The University of Texas Health Science Center, Houston. Fosamprenavir is a protease inhibitor that blocks HIV protease, preventing viral replication, and is boosted by ritonavir which inhibits its metabolism to increase drug levels.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
ritonavir-boosted fosamprenavir TARGET	ritonavir-boosted fosamprenavir	The University of Texas Health Science Center, Houston	marketed	HIV protease inhibitor	HIV protease
Highly active antiretroviral therapy	Highly active antiretroviral therapy	PETHEMA Foundation	marketed	Antiretroviral combination therapy	HIV reverse transcriptase, HIV protease, HIV integrase (depending on regimen composition)
Darunavir / Ritonavir + Tenofovir / Emtricitabine	Darunavir / Ritonavir + Tenofovir / Emtricitabine	Juan A. Arnaiz	marketed	Antiretroviral combination (protease inhibitor + nucleoside reverse transcriptase inhibitors)	HIV protease, HIV reverse transcriptase
Active comparator: DRV/cb	Active comparator: DRV/cb	Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud	marketed	HIV protease inhibitor with pharmacokinetic booster	HIV protease
Darunavir/Cobicistat (FDC)	Darunavir/Cobicistat (FDC)	Janssen Scientific Affairs, LLC	marketed	HIV protease inhibitor with pharmacokinetic booster	HIV protease; CYP3A4
Lopinavir/r plus saquinavir	Lopinavir/r plus saquinavir	The HIV Netherlands Australia Thailand Research Collaboration	marketed	HIV protease inhibitor combination	HIV protease
Atazanavir/Ritonavir + Famotidine	Atazanavir/Ritonavir + Famotidine	Bristol-Myers Squibb	marketed	HIV protease inhibitor (boosted) + H2-receptor antagonist	HIV protease; CYP3A4 (ritonavir); H2 receptor (famotidine)

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