NDAORALCAPSULEPriority Review
Approved
Nov 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
FORTOVASE (saquinavir) by Roche is mechanism of action saquinavir is an inhibitor of hiv protease. First approved in 1997.
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FORTOVASE (saquinavir) is an oral HIV protease inhibitor approved in 1997 that blocks HIV protease enzyme activity to prevent viral polyprotein cleavage and formation of infectious virus particles. It is used as part of combination antiretroviral therapy for HIV-1 infection. The drug represents a foundational class in HIV treatment but faces significant competition from newer, more potent agents.
LOE Approaching
As an older protease inhibitor nearing loss of exclusivity with moderate competitive pressure (30/100), FORTOVASE teams are likely smaller and focused on managed decline or niche retention strategies rather than expansion.
Mechanism of Action
Mechanism of Action Saquinavir is an inhibitor of HIV protease. HIV protease is an enzyme required for the proteolytic cleavage of viral polyprotein precursors into individual functional proteins found in infectious HIV. Saquinavir is a peptide-like substrate analogue that binds to the protease…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients
825 enrolled
HIV Infections
A Study of Saquinavir Used Alone or in Combination With Other Anti-HIV Drugs in HIV-Infected Patients
4,000 enrolled
HIV Infections
A Comparison of Nelfinavir Plus Saquinavir Plus Delavirdine or 3TC/ZDV Versus Nelfinavir Plus 3TC/ZDV in HIV-Infected Patients
0
HIV Infections
Fortovase (Saquinavir) Given With Low-Dose Ritonavir, Zidovudine, and Lamivudine to HIV-Positive Pregnant Women During and After Pregnancy and to Their Newborns
24 enrolled
HIV InfectionsPregnancy
The Anti-HIV Effects of Saquinavir Soft Gelatin Capsules Versus Indinavir in Patients Who Have Used Saquinavir Hard Gelatin Capsules for One Year
144 enrolled
HIV Infections
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.