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 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 hepatitis B virus (HBV) treatment. It works by inhibiting reverse transcriptase, blocking viral replication in HBV-infected patients. The drug is available as a tablet and represents a foundational antiretroviral therapy component.
$0.103MPart D
LOE ApproachingDeclining
As a maturing product approaching loss of exclusivity with minimal Part D spending, this brand operates with a lean team focused on cost management and transition planning rather than growth initiatives.
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)
An Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients With Chronic Hepatitis B
Hepatitis B
Fortovase (Saquinavir) Given With Low-Dose Ritonavir, Zidovudine, and Lamivudine to HIV-Positive Pregnant Women During and After Pregnancy and to Their Newborns
24 enrolled
HIV InfectionsPregnancy
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
A Phase II Open-Label Exploratory Study of Saquinavir + Zidovudine + Lamivudine in HIV Infected Patients
30 enrolled
HIV Infections
A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given With Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants
24 enrolled
HIV InfectionsPregnancy
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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.