fosamprenavir (GW433908) — Competitive Intelligence Brief

fosamprenavir (GW433908) (fosamprenavir (GW433908)) 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

fosamprenavir (GW433908) (fosamprenavir (GW433908)) — ViiV Healthcare. Fosamprenavir is a prodrug that is metabolized into amprenavir, a protease inhibitor.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
fosamprenavir (GW433908) TARGET	fosamprenavir (GW433908)	ViiV Healthcare	phase 3	Protease inhibitor	HIV protease
Combivir+Kaletra	Combivir+Kaletra	Hospital Clinic of Barcelona	marketed	Antiretroviral combination therapy (NRTI + protease inhibitor)	HIV reverse transcriptase and 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/tenofovir/emtricitabine	atazanavir/tenofovir/emtricitabine	Community Research Initiative of New England	marketed	Antiretroviral combination (protease inhibitor + nucleoside/nucleotide reverse transcriptase inhibitors)	HIV protease, HIV reverse transcriptase
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 (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