TheraRadar
Data updated: Mar 29, 2026

ESLICARBAZEPINE ACETATE

ESLICARBAZEPINE ACETATE
Neurology Approved 2021-06-29

Eslicarbazepine acetate is a medication indicated for the treatment of partial-onset seizures. It is approved for use in both adult and pediatric patients 4 years of age and older. The drug provides a therapeutic option for managing this specific type of seizure activity within the indicated population.

Source: FDA Label • Dr. Reddy's
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How ESLICARBAZEPINE ACETATE Works

Eslicarbazepine acetate is a prodrug that is extensively converted into eslicarbazepine, the active component responsible for its therapeutic effects. While the precise mechanism of action is not fully known, it is believed to involve the inhibition of voltage-gated sodium channels. By interacting with these channels, the drug exerts anticonvulsant activity to help regulate electrical signaling in the brain.

Source: FDA Label
8
Indications
--
Phase 3 Trials
4
Years on Market

Details

Status
Prescription
First Approved
2021-06-29
Routes
ORAL
Dosage Forms
TABLET

Companies

Dr. Reddy's ALKEM LABS LTD Apotex JUBILANT GENERICS TORRENT Lupin SPH ZHONGXI PHARM Aurobindo Pharma HETERO LABS LTD V
Active Ingredient: ESLICARBAZEPINE ACETATE

ESLICARBAZEPINE ACETATE Approval History

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What ESLICARBAZEPINE ACETATE Treats

1 indications

ESLICARBAZEPINE ACETATE is approved for 1 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Partial-Onset Seizures
Source: FDA Label

Drugs Similar to ESLICARBAZEPINE ACETATE

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AFINITOR DISPERZ
EVEROLIMUS
1 shared
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Shared indications:
Partial-Onset Seizures
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Partial-Onset Seizures
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1 shared
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SUBVENITE
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Shared indications:
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Trial Timeline

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Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ESLICARBAZEPINE ACETATE FDA Label Details

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Indications & Usage

Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.

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Data Sources

FDA Approval: ANDA211238 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.