NDAORALCAPSULE, DELAYED REL PELLETS
Approved
Aug 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
9
Data completeness
3/8 — Basic
Drug data last refreshed 2h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CYMBALTA (duloxetine HCl) is an oral serotonin-norepinephrine reuptake inhibitor (SNRI) small molecule approved in 2004 by Eli Lilly. It is indicated for depression, anxiety disorders, diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain. The drug works by increasing synaptic concentrations of serotonin and norepinephrine through dual reuptake inhibition.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), indicating defensive strategy and reduced team expansion opportunities.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (9)
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.