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 9h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EPIVIR (lamivudine) is an oral nucleoside reverse transcriptase inhibitor (NRTI) approved in 1995 for treatment of hepatitis B virus and HIV infection. It works by inhibiting reverse transcriptase, blocking viral replication in infected cells. This small-molecule antiviral is typically used as part of combination antiretroviral therapy.
LOE Approaching
Declining
Minimal commercial opportunity as a standalone product; lamivudine is now primarily marketed in fixed-dose combinations with larger teams supporting TRIUMEQ and DOVATO.
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)
A Study to Evaluate the Safety and Tolerance of Stavudine (d4T) in Combination With Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants
26 enrolled
HIV InfectionsPregnancy
Zidovudine and Lamivudine Given Once Versus Twice Daily
20 enrolled
HIV Infections
Safety and Effectiveness of Giving Indinavir Plus Stavudine Plus Lamivudine to HIV-Infected Children
24 enrolled
HIV Infections
An Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients With Chronic Hepatitis B
Hepatitis B
A Comparison of Zidovudine Plus Lamivudine Versus ddI Used Alone or in Combination With Zidovudine in HIV-1 Infected Children
740 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.