RETROVIR
LOE ApproachingNDAORALTABLET
Approved
Dec 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
RETROVIR by GSK is [see microbiology ()] . Approved for maternal-fetal hiv-1 transmission [see dosage, administration ()], combination with other antiretroviral agents for the treatment of hiv-1 infection. First approved in 1995.
Drug data last refreshed 10h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RETROVIR (zidovudine) is an oral small-molecule antiretroviral nucleoside reverse transcriptase inhibitor approved in 1995 for HIV-1 treatment and prevention of maternal-fetal transmission. It works by inhibiting HIV-1 reverse transcriptase, blocking viral replication. RETROVIR is typically used in combination with other antiretroviral agents as part of highly active antiretroviral therapy (HAART).
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), suggesting brand team will shift focus to lifecycle extension and managed decline strategies.
Mechanism of Action
[see Microbiology ()] .
Clinical Trials (20)
A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease
390 enrolled
HIV Infections
Discontinuation of Antiretroviral Therapy in Patients With Asymptomatic HIV Infection
158 enrolled
HIV Infections
A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs
200 enrolled
HIV Infections
The Safety and Effectiveness of Retrovir Plus HIVID Combined With Either Nevirapine or Invirase in the Treatment of HIV Infection
225 enrolled
HIV Infections
A Pilot Study of Triple NtRTI/NsRTI Therapy in Antiretroviral Naive HIV-1 Infected Patients
HIV
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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.