VIRAMUNE
LOE ApproachingNDAORALSUSPENSIONPriority Review
Approved
Sep 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
15
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 22h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VIRAMUNE (nevirapine) is an oral suspension small-molecule antiretroviral approved in 1998 for HIV infection and AIDS. It functions as a non-nucleoside reverse transcriptase inhibitor (NNRTI) that blocks HIV replication by inhibiting the reverse transcriptase enzyme. This drug represents a foundational component of combination antiretroviral therapy regimens.
LOE Approaching
Product approaching loss of exclusivity with minimal Part D spending data; brand team likely managing transition to generic or focusing on legacy market segments.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
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.