VIRAMUNE
LOE ApproachingNDAORALSUSPENSIONPriority Review
Approved
Sep 1998
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 1998.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VIRAMUNE is an oral suspension small-molecule antiviral approved in 1998 by Boehringer Ingelheim. The drug's specific indication and mechanism of action are not disclosed in available data, but the suspension formulation suggests pediatric or patient populations requiring liquid dosing. As a product approaching loss of exclusivity, VIRAMUNE represents a mature therapeutic asset.
LOE Approaching
With LOE approaching and competitive pressure at 30%, the brand team is likely focused on lifecycle extension and preparing for generic entry rather than expansion.
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.