NDAORALTABLET
Approved
Dec 1981
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
3
Data completeness
4/8 — Partial
DESYREL (trazodone hydrochloride) by Pragma Bio is trazodone's antidepressant action is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the cns. First approved in 1981.
Drug data last refreshed 17h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DESYREL (trazodone hydrochloride) is an oral antidepressant approved in 1981 that works through serotonergic enhancement via SSRI and 5HT2 receptor antagonism, though the exact mechanism remains incompletely understood. It is indicated for major depressive disorder and is available as a tablet formulation.
LOE Approaching2.4 years to LOE
Product is approaching loss of exclusivity with 2.5 years remaining, indicating a contracted team focused on managed decline and generic transition planning.
Mechanism of Action
trazodone's antidepressant action is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS. Trazodone is both a selective serotonin reuptake inhibitor (SSRI) and a 5HT2 receptor antagonist and the net result of this action on serotonergic…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
PK Study of Multi-dose Trazodone Hydrochloride Prolonged-released Tablets in Healthy Chinese
Started May 2017
12 enrolled
Depression
PK Study of Diet Effect of Trazodone Hydrochloride Prolonged-Released Tablets in Healthy Chinese
Started May 2017
15 enrolled
Depression
A Clinical Study of Trazodone Hydrochloride Prolonged-Release Tablets for Treatment of Depression
Started Nov 2011
382 enrolled
Depression
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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.