NDATOPICALCREAM2 Generics Approved
Approved
Dec 2002
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
20
Data completeness
4/8 — Partial
ZOVIRAX (acyclovir) by Bausch + Lomb is dna polymerase inhibitors [moa]. Approved for herpes simplex virus nucleoside analog dna polymerase inhibitor [epc]. First approved in 2002.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZOVIRAX (acyclovir) is a topical cream formulation of a nucleoside analog DNA polymerase inhibitor indicated for herpes simplex virus infection. It works by inhibiting viral DNA replication, preventing viral spread and reducing symptom severity. This is a mature, well-established antiviral with decades of clinical use.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (60/100), suggesting a consolidating team and transition focus toward generic optimization or line extension strategies.
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.