DEPAKOTE ER
LOE ApproachingNDAOralTablet, Extended Release
Approved
Dec 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
15
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 15h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DEPAKOTE ER is an extended-release oral tablet containing divalproex sodium, approved in 2002 for acute manic and mixed episodes associated with bipolar disorder (with or without psychotic features) and migraine headache prophylaxis. The exact mechanism is not fully established, but it is believed to work by increasing brain concentrations of gamma-aminobutyric acid (GABA), a neurotransmitter that reduces neuronal excitability.
$11MPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Medicare spending ($11M, ~17,500 claims in 2023); commercial team likely focused on differentiation and managed market defense.
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.