NDAORALSOLUTIONPriority Review
Approved
Nov 1995
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
EPIVIR (lamivudine) by GSK is nucleoside reverse transcriptase inhibitors [moa]. Approved for hepatitis b virus nucleoside analog reverse transcriptase inhibitor [epc]. First approved in 1995.
Drug data last refreshed 13h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EPIVIR (lamivudine) is a nucleoside reverse transcriptase inhibitor (NRTI) approved in 1995 for treating hepatitis B virus infection. It works by inhibiting reverse transcriptase, blocking viral replication in HBV-infected patients. This oral solution is often used as a component in combination antiretroviral regimens.
LOE Approaching
Declining
EPIVIR is in late-stage lifecycle with minimal standalone spending ($103K), indicating a small, maintenance-focused commercial team primarily supporting combination products.
Mechanism of Action
Nucleoside Reverse Transcriptase Inhibitors
Pharmacologic Class:
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Safety and Effectiveness of Ritonavir Plus Lamivudine Plus Zidovudine in HIV-Infected Pregnant Women and Their Babies
14 enrolled
HIV InfectionsPregnancy
A Study to Compare the Safety and Effectiveness of Indinavir Combined With Stavudine and Lamivudine
186 enrolled
HIV Infections
An Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients With Chronic Hepatitis B
Hepatitis B
Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children
24 enrolled
HIV Infections
Addition of Efavirenz or Nelfinavir to a Lamivudine/Zidovudine/Indinavir HIV Treatment Regimen
444 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.