DEPAKOTE ER
LOE ApproachingNDAOralTablet, Extended Release
Approved
Dec 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
13
Data completeness
5/8 — Partial
DEPAKOTE ER by Abbott is tract. Approved for acute manic, mixed episodes associated with bipolar disorder, with and 4 more indications. First approved in 2002.
Drug data last refreshed 21h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DEPAKOTE ER is an oral extended-release tablet formulation of divalproex sodium approved in December 2002 for the treatment of acute manic and mixed episodes associated with bipolar disorder (with or without psychotic features) and migraine headache prophylaxis in women and women of childbearing potential. The drug is a small-molecule anticonvulsant whose therapeutic mechanism is not fully established but is believed to involve increased brain concentrations of gamma-aminobutyric acid (GABA). As an extended-release formulation, it provides improved dosing convenience compared to immediate-release alternatives while maintaining efficacy in mood disorder and migraine management.
$0.0BPart D
Mechanism of Action
tract. The mechanisms by which valproate exerts its therapeutic effects have not been established. It has been suggested that its activity in epilepsy is related to increased brain concentrations of gamma-aminobutyric acid (GABA).
Indications (7)
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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.