NDAORALTABLETPriority Review
Approved
Sep 1997
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
12
Data completeness
6/8 — Strong
Priority Review
COMBIVIR (lamivudine and zidovudine) by GSK is nucleoside reverse transcriptase inhibitors [moa]. Approved for hepatitis b virus nucleoside analog reverse transcriptase inhibitor [epc]. First approved in 1997.
Drug data last refreshed 5h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COMBIVIR is a fixed-dose combination of lamivudine and zidovudine, two nucleoside reverse transcriptase inhibitors (NRTIs) used to treat HIV-1 infection. It works by inhibiting reverse transcriptase, preventing viral replication in infected CD4+ T cells. This oral tablet formulation has been a foundational antiretroviral therapy since its 1997 approval.
$0.168MPart D
LOE ApproachingDeclining
Minimal commercial infrastructure; product in late decline with contracted team focus on cost management and existing patient retention.
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 (12)
A Study to Evaluate the Bioequivalence of a Combined Formulated Tablet Compared With Maraviroc and Combivir™
Started Nov 2011
42 enrolled
Infection, Human Immunodeficiency Virus I
Combivir And Maraviroc In Antiretroviral Naive Subjects In Russia
Started Jun 2011
98 enrolled
HIV
Switch From Combivir or Trizivir to Truvada - Mitochondrial Effects
Started Aug 2006
17 enrolled
HIV
Trizivir Vs. Kaletra and Combivir for the Prevention of Mother-to-Child Transmission of HIV
Started Jun 2006
730 enrolled
HIV Infections
GW873140 In Combination With Combivir In HIV Infected Subjects
Started Jan 2005
125 enrolled
Infection, Human Immunodeficiency Virus IHIV Infection
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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.