DEPAKOTE ER
LOE ApproachingNDAORALTABLET, EXTENDED RELEASEPriority Review
Approved
Mar 2008
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
13
Data completeness
5/8 — Partial
Priority Review
DEPAKOTE ER by AbbVie is tract. Approved for acute manic, mixed episodes associated with bipolar disorder, with and 4 more indications. First approved in 2008.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DEPAKOTE ER is an extended-release oral tablet formulation of valproate approved for acute manic and mixed episodes associated with bipolar disorder (with or without psychotic features) and migraine headache prophylaxis. The mechanism of action is not fully established, but is suggested to relate to increased brain concentrations of gamma-aminobutyric acid (GABA).
$11MPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Medicare spending ($11M) signals a shrinking team and shift toward defensive maintenance positioning.
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)
Worked on DEPAKOTE ER at AbbVie? Share your interview experience or compensation data (+7 days Pro)
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.