NDAORALTABLET, DELAYED RELEASE
Approved
Mar 1983
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
DEPAKOTE (divalproex sodium) by AbbVie is tract. First approved in 1983.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DEPAKOTE (divalproex sodium) is an oral delayed-release tablet approved in 1983 for epilepsy, bipolar disorder, and migraine prevention. Its therapeutic mechanism is not fully established but is thought to involve increased brain GABA concentrations. It remains a foundational treatment across three major CNS indications.
LOE Approaching
Approaching loss of exclusivity with moderate competitive pressure (30/100), signaling transition from growth to defensive strategy and potential team contraction.
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
Bioequivalence Study of Divalproex Sodium Capsules(Sprinkle),125 mg of Dr. Reddy's Under Fasting Condition (Apple Sauce)
Started Feb 2007
34 enrolled
Healthy
Bioequivalence Study of Dr. Reddy's Divalproex Sodium Coated Particles in Capsules, 125 mg, Under Fed Condition
Started Dec 2006
34 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.