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 1h ago · AI intelligence enriched 1w 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 Pilot Study of Triple NtRTI/NsRTI Therapy in Antiretroviral Naive HIV-1 Infected Patients
HIV
A Randomized Trial of the Efficacy and Safety of a Strategy of Starting With Nelfinavir Versus Ritonavir Added to Background Antiretroviral (AR) Nucleoside Therapy in HIV-Infected Individuals With CD4+ Cell Counts Less Than or Equal to 200/mm3
1,300 enrolled
HIV Infections
A Randomized, Parallel Arm, Comparative, Open Label, Multicenter Study of the Activity and Safety of Two Formulations of Saquinavir in Combination With Other Antiretroviral Drugs
140 enrolled
HIV Infections
A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine
24 enrolled
Cytomegalovirus InfectionsHIV Infections
A Study of the Safety and Effectiveness of Hydroxyurea in Patients on Potent Antiretroviral Therapy and Who Have Less Than 200 Copies/ml of HIV RNA in Their Blood
399 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.