NDAORALCAPSULE
Approved
Jan 1972
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
DOXEPIN HYDROCHLORIDE (doxepin hydrochloride) by Quantum Genomics is understood. First approved in 1972.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Doxepin hydrochloride is an oral capsule tricyclic antidepressant approved in 1972 for treating oral mucositis and pain. It works through unknown mechanisms but is believed to enhance serotonergic and noradrenergic activity in the central nervous system, providing both analgesic and anxiolytic effects.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); expect contraction in brand team size and shift toward generic support or indication migration.
Mechanism of Action
understood.
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
Career Relevance
Working on doxepin offers stability in a mature product but limited growth opportunity as LOE approaches; career advancement depends on driving indication expansion or transitioning to generic lifecycle support. Focus shifts from launch activities to defensive positioning and margin protection.
Brand Manager
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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.