NDATOPICALOINTMENTPriority Review
Approved
Mar 1982
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
ZOVIRAX (acyclovir) by Bausch + Lomb is dna polymerase inhibitors [moa]. Approved for herpes simplex virus nucleoside analog dna polymerase inhibitor [epc]. First approved in 1982.
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZOVIRAX (acyclovir) is a topical ointment containing a nucleoside analog that inhibits herpes simplex virus DNA polymerase. It treats herpes simplex, herpes labialis, genital herpes, and chickenpox by blocking viral DNA replication at the site of infection. The drug has been the cornerstone of topical antiviral therapy since FDA approval in 1982.
LOE Approaching
Brand team is likely in defensive/transition mode as loss of exclusivity approaches; expect smaller commercial footprint and focus on generic competition management.
Mechanism of Action
DNA Polymerase Inhibitors
Pharmacologic Class:
Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
The Bioequivalence Study of Acyclovir 800 mg Tablet in Healthy Thai Volunteers Under Fasting Conditions
Started Feb 2024
40 enrolled
Healthy Volunteer
Neonatal Phase 1 Valacyclovir Study
Started Aug 2023
17 enrolled
Herpes Simplex
A Study to Compare Sitavig (Acyclovir) Buccal Tablet With a Placebo in the Treatment of Herpes Labialis in Participants Whose Immune System Works Normally
Started Nov 2021
2,020 enrolled
Recurrent Herpes Labialis
Pharmacokinetic Properties of 200 and 400 mg Acyclovir Tablet in Indonesia Healthy Subject
Started Feb 2020
56 enrolled
Drug Use
Study of the Efficacy and Safety of Combined Treatment of Patients With Severe Herpes Simplex (HSV) Infection by Valacyclovir and Interferon Inducer Kagocel
Started Oct 2017
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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.