NDAORALTABLET, EXTENDED RELEASE
Approved
Aug 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
DEPAKOTE ER (divalproex sodium) by AbbVie is tract. First approved in 2000.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DEPAKOTE ER is an extended-release oral tablet formulation of divalproex sodium, a anticonvulsant agent approved in 2000. It is primarily indicated for epilepsy management, with therapeutic effects believed to be mediated through increased brain GABA concentrations. The extended-release formulation allows for once-daily dosing, improving patient compliance compared to immediate-release alternatives.
LOE Approaching
As loss of exclusivity approaches, the commercial team is likely contracting and shifting focus toward managed care strategy and generic mitigation rather than growth initiatives.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Bioequivalence Study of Divalproex Sodium ER Tablets, 500 mg Under Fed Conditions
Started Jan 2011
54 enrolled
Healthy
Bioequivalence Study of Divalproex Sodium ER Tablets 500 mg of Dr. Reddy's Under Fasting Conditions
Started Jan 2011
54 enrolled
Healthy
Quetiapine SR and Divalproex Sodium ER in the Treatment of Anxiety in Bipolar Disorder With Panic Disorder and/or GAD
Started Jul 2007
224 enrolled
Bipolar DisorderPanic DisorderGeneralized Anxiety Disorder
Fed Bioequivalence Study of Divalproex Sodium Delayed-Release Tablets, 500 mg
Started Jul 2007
20 enrolled
Healthy
Bioequivalence Study of Divalproex Sodium Delayed-Release Tablets, 500 mg
Started Jul 2007
17 enrolled
Healthy
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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.