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 Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EPIVIR (lamivudine) is an oral nucleoside reverse transcriptase inhibitor approved in 1995 for HIV infection and hepatitis B. It works by blocking reverse transcriptase enzyme activity, preventing viral replication in patients with HIV or chronic hepatitis B infection.
$0.103BPart D
LOE ApproachingDeclining
Product in late-stage lifecycle with minimal Part D spending suggests small, maintenance-focused commercial team with limited growth opportunities.
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 of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir in HIV-Infected Patients
500 enrolled
HIV Infections
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
The Effectiveness of Indinavir Plus Zidovudine Plus Lamivudine in HIV-Infected Patients With No Symptoms of Infection
200 enrolled
HIV Infections
Safety and Effectiveness of Giving an Anti-HIV Drug Combination of Adefovir Dipivoxil Plus Didanosine Plus Efavirenz Plus Lamivudine Once Daily to HIV-Infected Patients
25 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.