NDAORALCONCENTRATE
Approved
Mar 1974
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
SINEQUAN (doxepin hydrochloride) by Pfizer is clinical pharmacology the mechanism of action of doxepin is not definitely known. First approved in 1974.
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SINEQUAN (doxepin HCl) is a tricyclic antidepressant approved in 1974 that works by preventing reuptake of norepinephrine at nerve terminals, enhancing adrenergic activity in the central nervous system. It is indicated for depression and anxiety disorders and is available as an oral concentrate formulation. Doxepin has a favorable abuse profile with minimal euphoria and no demonstrated physical tolerance or psychological dependence.
LOE Approaching
Product is in late lifecycle stage with moderate competitive pressure (30/100), indicating reduced team expansion and shift toward lifecycle management and generic defense strategies.
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.