CYMBALTA
LOE ApproachingNDAORALCAPSULE, DELAYED REL PELLETS
Approved
Aug 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
4/8 — Partial
CYMBALTA by Eli Lilly and Company is antidepressant, central pain inhibitory and anxiolytic actions of duloxetine in humans are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the cns. First approved in 2004.
Drug data last refreshed 10h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Cymbalta (duloxetine hydrochloride) is an oral serotonin-norepinephrine reuptake inhibitor (SNRI) approved for depression, anxiety, diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain. The delayed-release capsule formulation allows once-daily dosing and reduces gastrointestinal side effects. It works by increasing synaptic concentrations of serotonin and norepinephrine in the central nervous system.
LOE Approaching
Product is nearing loss of exclusivity with moderate competitive pressure (30), signaling reduced team expansion and increasing focus on cost management and retention strategies.
Mechanism of Action
antidepressant, central pain inhibitory and anxiolytic actions of duloxetine in humans are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the CNS.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
A Study of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta
Started Mar 2020
0Healthy
A Study Of Duloxetine Hydrochloride Hard Gelatinous Capsule Compared To Cymbalta Under Fed Conditions
Started Mar 2020
0Healthy
The Cymbalta Pregnancy Registry
Started Jul 2009
144 enrolled
Pregnancy
Cymbalta for Depression as a Complication of Bereavement
Started Apr 2008
20 enrolled
DepressionBereavement
Post-Marketing Surveillance Study on the Safety and Efficacy of Cymbalta (Duloxetine) on Diabetic Peripheral Neuropathic Pain Among Filipino Patients
Started Jul 2006
269 enrolled
Pain
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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.