NDAORALTABLETPriority Review
Approved
Nov 1995
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
20
Data completeness
6/8 — Strong
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 3h 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 viral reverse transcriptase, preventing viral replication in infected cells. The drug is now primarily used as a component of combination antiretroviral regimens rather than as monotherapy.
$0.103MPart D
LOE ApproachingDeclining
Minimal commercial momentum with only 281 Part D claims in 2023; EPIVIR monotherapy team is likely small and focused on managed decline or transition to combination formulations.
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
The Effectiveness of Ritonavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients
55 enrolled
HIV Infections
A Study to Evaluate the Safety and Tolerance of Combination Anti-HIV Drug Therapy (Indinavir, Lamivudine, and Zidovudine) in HIV-Positive Pregnant Women and Their Infants
24 enrolled
HIV InfectionsPregnancy
Safety and Effectiveness of Giving Indinavir, Ritonavir, Stavudine, and Lamivudine to HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
8 enrolled
HIV Infections
A Study of Indinavir Sulfate Plus Zidovudine (AZT) Plus Lamivudine in HIV-Infected Patients Who Have Taken AZT for Six or More Months
1,750 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.