NDAORALTABLET, EXTENDED RELEASE
Approved
Feb 2010
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
3
Data completeness
4/8 — Partial
OLEPTRO (trazodone hydrochloride) by Mthera Pharma 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 2010.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OLEPTRO is an extended-release oral tablet formulation of trazodone hydrochloride, a serotonergic antidepressant approved in 2010. It treats major depressive disorder through dual mechanisms: selective serotonin reuptake inhibition and 5HT2 receptor antagonism, though the precise interplay of these actions remains incompletely understood. The product is a small-molecule NDA indicated for depression in adult patients.
LOE Approaching2.5 years to LOE
With loss of exclusivity approaching in 2029, OLEPTRO faces imminent generic competition and will require defensive commercial strategies to retain market share.
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 Diet Effect of Trazodone Hydrochloride Prolonged-Released Tablets in Healthy Chinese
Started May 2017
15 enrolled
Depression
PK Study of Multi-dose Trazodone Hydrochloride Prolonged-released Tablets in Healthy Chinese
Started May 2017
12 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.