NDAORALCAPSULEPriority Review
Approved
Jun 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
APTIVUS (tipranavir) by Boehringer Ingelheim is hiv protease inhibitors [moa]. Approved for protease inhibitor [epc]. First approved in 2005.
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
APTIVUS (tipranavir) is an oral HIV protease inhibitor approved in 2005 for treatment-experienced patients with HIV-1 infection. It works by blocking the viral protease enzyme, preventing HIV replication and viral maturation. The drug is indicated for protease inhibitor-experienced patients as part of combination antiretroviral therapy.
LOE Approaching
Product faces patent expiration with moderate competitive pressure (30/100), indicating a contracting team and transition focus toward managed care and generic erosion strategies.
Mechanism of Action
HIV Protease Inhibitors
Pharmacologic Class:
Protease Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Drug Interaction Study Between GSK1349572 and Tipranavir/Ritonavir in Healthy Volunteers
Started Feb 2010
18 enrolled
Infection, Human Immunodeficiency VirusHIV Infections
A Post Marketing Surveillance Study Assessing the Long-term Efficacy and Safety of Aptivus Co-administered With Low-dose Ritonavir in Treatment Experienced Patients With HIV-1 Infection in the Daily Clinical Practice.
Started Sep 2009
42 enrolled
HIV Infections
Bioequivalence of Two Different Oral Solutions Tipranavir Administered in Combination With Ritonavir to Healthy Volunteers
Started Apr 2008
32 enrolled
Healthy
Tipranavir/Ritonavir Low Dose Pharmacokinetics in Treatment Naive Patients
Started Oct 2007
85 enrolled
HIV Infections
Effects of Steady State Tipranavir/Ritonavir or Darunavir/Ritonavir or Ritonavir on Platelet Function, Coagulation and Fibrinolysis Biomarkers in Healthy Subjects
Started Aug 2007
52 enrolled
Healthy
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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.