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Data updated: Mar 10, 2026

KEPPRA

LEVETIRACETAM
Neurology Approved 1999-11-30
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
11
Indications
--
Phase 3 Trials
2
Priority Reviews
26
Years on Market

Details

Status
Prescription
First Approved
1999-11-30
Routes
INTRAVENOUS, ORAL
Dosage Forms
INJECTABLE, SOLUTION, TABLET

Companies

UCB INC
Active Ingredient: LEVETIRACETAM

KEPPRA Approval History

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What KEPPRA Treats

3 indications

KEPPRA is approved for 3 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Partial-Onset Seizures
  • Myoclonic Seizures
  • Primary Generalized Tonic-Clonic Seizures
Source: FDA Label

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

KEPPRA FDA Label Details

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Indications & Usage

FDA Label (PDF)

KEPPRA is indicated for the treatment of partial-onset seizures in patients 1 month of age and older KEPPRA is indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy 1.1 Partial-Onset Seizures KEPPRA is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy KEPPRA is indicated as adjuncti...

KEPPRA Patents & Exclusivity

Latest Patent: Dec 2031

Patents (32 active)

US8802142*PED Expires Dec 7, 2031
US8802142 Expires Jun 7, 2031
+ 22 more patents
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA021872 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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