NDAORALTABLETPriority Review
Approved
Dec 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
3/8 — Basic
Priority Review
INVIRASE (saquinavir mesylate) by Roche is mechanism of action saquinavir is an inhibitor of hiv protease. First approved in 2004.
Drug data last refreshed 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INVIRASE (saquinavir mesylate) is an oral HIV protease inhibitor approved in 2004 that blocks cleavage of viral polyproteins, preventing formation of infectious HIV particles. It is used as part of combination antiretroviral therapy for HIV-1 infected patients. The drug represents a foundational class in HIV treatment but faces significant competition from newer protease inhibitors and integrase-based regimens.
LOE Approaching
As INVIRASE approaches loss of exclusivity with moderate competitive pressure (30/100), brand teams are likely consolidating to preservation and transition planning rather than growth initiatives.
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 (6)
A Study of Ritonavir-Boosted Invirase (Saquinavir) in Treatment-Naïve HIV-1 Infected Patients
Started Jan 2012
23 enrolled
HIV Infections
Observational Study on Predictors of Response to Invirase (Saquinavir) Treatment in Treatment-naïve Patients With HIV Infection
Started Aug 2010
151 enrolled
HIV Infections
A Study of Invirase (Saquinavir)/Ritonavir in HIV-Infected Infants and Children.
Started Jun 2008
18 enrolled
HIV Infections
Lopinavir Capsules to Kaletra or Invirase Tablets
Started Sep 2006
53 enrolled
HIV Infections
Lopinavir/Ritonavir in Combination With Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects
Started Aug 2002
30 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.