VIRAMUNE
LOE ApproachingNDAORALTABLETPriority Review
Approved
Jun 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
15
Data completeness
3/8 — Basic
Priority Review
VIRAMUNE by Boehringer Ingelheim is [ see clinical pharmacology ]. First approved in 1996.
Drug data last refreshed 48m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VIRAMUNE is an oral small-molecule antiretroviral agent approved in 1996 for HIV treatment. The drug's specific mechanism of action and approved indications are not detailed in available data, but its oral tablet formulation reflects standard HIV therapy delivery. It represents a foundational antiretroviral from the mid-1990s era.
LOE Approaching
Approaching loss of exclusivity with moderate competitive pressure (30%) signals a mature, potentially contracting brand team focused on cost management and market defense rather than growth initiatives.
Mechanism of Action
[ see Clinical Pharmacology ].
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (15)
Non-interventional Observational Study With Viramune® in HIV to Evaluate Gender Specific Data
Started May 2010
265 enrolled
HIV Infections
Non-interventional Observational Study With Viramune (Nevirapine) and Various Drug Combinations in the Antiretroviral Combination Treatment of HIV-infected Patients Who Have Already Been Treated for Approx. 10 Years With Viramune
Started Aug 2009
HIV Infections
Non-Interventional Observational Study With Viramune Plus Antiretroviral in HIV Infected Patients
Started Mar 2009
605 enrolled
HIV Infections
Pharmacokinetic Properties of Two Dosages Nevirapine Extended Release (XR) Formulations Compared to VIRAMUNE® Tablet as Well as to Nevirapine XR Tablet in Healthy Male Volunteers
Started Apr 2008
96 enrolled
Healthy
Bioavailability of 2 Different Nevirapine Extended Release Formulations Compared to Viramune® in HIV-1 Infected Subjects
Started Dec 2006
92 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.