NDATOPICALCREAM
Approved
Apr 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
5/8 — Partial
ZONALON (doxepin hydrochloride) by Viatris (2) is clinical pharmacology the mechanism of action of doxepin is not definitely known. Approved for oral mucositis. First approved in 1994.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZONALON (doxepin HCl) is a topical cream formulation of a tricyclic compound that modulates norepinephrine reuptake at synapses, preventing deactivation and enhancing adrenergic activity. It is indicated for oral mucositis, head and neck cancer-related pain, and general pain management. The drug works through anticholinergic, antiserotonin, and antihistamine effects on smooth muscle, without CNS stimulation or addiction liability.
$0.019MPart D
LOE ApproachingMinimal commercial activity with only 25 Part D claims in 2023 signals a niche, specialty product with limited sales force size and defensive positioning.
Mechanism of Action
CLINICAL PHARMACOLOGY The mechanism of action of doxepin is not definitely known. It is not a central nervous system stimulant nor a monoamine oxidase inhibitor. The current hypothesis is that the clinical effects are due, at least in part, to influences on the adrenergic activity at the synapses…
Indications (1)
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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.