NDATOPICALCREAM
Approved
Apr 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
ZONALON (doxepin hydrochloride) by Viatris (2) is clinical pharmacology the mechanism of action of doxepin is not definitely known. First approved in 1994.
Drug data last refreshed 10h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZONALON (doxepin hydrochloride) is a tricyclic antidepressant formulated as a topical cream for dermatological use. It works by preventing reuptake of norepinephrine at synapses and exhibits antihistamine and anticholinergic properties on smooth muscle. The mechanism provides localized therapeutic benefit without systemic abuse potential.
$0.019BPart D
LOE ApproachingProduct approaching loss of exclusivity with minimal Part D claims (25 in 2023) signals a niche, mature asset with limited commercial growth potential and likely small team footprint.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy
Started Dec 2010
155 enrolled
Head and Neck CancerMucositisOral Complications of Radiation Therapy+1 more
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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.