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 8h ago · AI intelligence enriched 1mo 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 Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children
50 enrolled
HIV Infections
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
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
A Study of Saquinavir Soft Gelatin Capsules Plus Zidovudine Plus Lamivudine in the Treatment of HIV-1 Infected Patients Who Have Never Taken Anti-HIV Drugs
40 enrolled
HIV Infections
Safety and Tolerance of Indinavir Plus Ritonavir in HIV-Positive Patients Failing Therapy With Amprenavir, Nelfinavir, or Saquinavir
50 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.