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 9h 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 Phase IIIB Open-Label, Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) Treatment in Combination With Other Antiretrovirals in HIV-1 Infected Antiretroviral-Naive Patients
375 enrolled
HIV Infections
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Adefovir Dipivoxil When Added to Standard Antiretroviral Therapy for the Treatment of HIV-Infected Patients With CD4 Cell Counts >= 200/mm3
400 enrolled
HIV Infections
A Phase II Study of Intermittent Recombinant Human Interleukin-2 (rhIL-2) by Intravenous or Subcutaneous Administration in Subjects With HIV Infection on Highly Active Antiretroviral Therapy (HAART) Compared to HAART Alone
200 enrolled
HIV Infections
Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy (0518-023)
HIV Infections
A Pilot Study of Triple NtRTI/NsRTI Therapy in Antiretroviral Naive HIV-1 Infected Patients
HIV
Worked on RETROVIR at GSK? Share your interview experience or compensation data (+7 days Pro)
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.