NDABUCCALTABLET
Approved
Apr 2013
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
5/8 — Partial
SITAVIG (acyclovir) by Charter Medical is dna polymerase inhibitors [moa]. First approved in 2013.
Drug data last refreshed 22h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SITAVIG is a buccal tablet formulation of acyclovir, a nucleoside analog that inhibits viral DNA polymerase to treat herpes simplex virus infections. It is indicated for the treatment of recurrent oral herpes labialis (cold sores) in immunocompetent adults. The buccal delivery system provides localized therapy at the site of infection with systemic absorption.
$0.026BPart D
LOE ApproachingDeclining
3.6 years to LOELimited market penetration with minimal Part D claims signals a niche product in decline; expect small, focused commercial teams managing defensive strategy rather than growth.
Mechanism of Action
DNA Polymerase Inhibitors
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.