TheraRadar
Data updated: Mar 29, 2026

LEVETIRACETAM

LEVETIRACETAM
Neurology Approved 2008-11-04

Levetiracetam is an antiepileptic medication indicated for the treatment of partial-onset seizures in patients one month of age and older. It is also indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy.

Source: FDA Label • ZYDUS PHARMS USA INC
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How LEVETIRACETAM Works

The precise mechanism by which levetiracetam exerts its antiepileptic effect is unknown. However, it is known to bind to the synaptic vesicle protein SV2A in neuronal tissue, which is believed to be involved in the regulation of vesicle exocytosis and neurotransmitter release. The affinity of levetiracetam for SV2A correlates with its potency in preventing seizures, suggesting that this interaction contributes to its therapeutic mechanism of action.

Source: FDA Label
71
Indications
--
Phase 3 Trials
17
Years on Market

Details

Status
Prescription
First Approved
2008-11-04
Routes
ORAL, INTRAVENOUS
Dosage Forms
TABLET, INJECTABLE, SOLUTION, TABLET, EXTENDED RELEASE

Companies

ZYDUS PHARMS USA INC INGENUS PHARMS LLC Sun Pharma AMNEAL PHARMS Teva ZHEJIANG JINGXIN Aurobindo Pharma AM REGENT SCIEGEN PHARMS CHARTWELL RX SAGENT PHARMS Pfizer EPIC PHARMA LLC MSN PRINSTON INC TOLMAR RISING Lupin Apotex ROUSES POINT PHARMS EUGIA PHARMA ANDA REPOSITORY STRIDES PHARMA PHARMOBEDIENT CNSLTG Hikma ACCORD HLTHCARE Fresenius Kabi Novartis LOTUS PHARM CO LTD JUBILANT GENERICS OVERSEAS FOSUN PHARMA INVAGEN PHARMS ADAPTIS HETERO LABS LTD III HISUN PHARM HANGZHOU Viatris TARO BIONPHARMA QUAGEN CHARTWELL MOLECULAR ORBION PHARMS MPP PHARMA TORRENT PHARMS LTD PH HEALTH PHARM ASSOC PHARMADAX INC GUARDIAN DRUG OXFORD PHARMS TORRENT PHARMS ALEMBIC AIPING PHARM INC MICRO LABS SENORES PHARMS WATSON LABS INC VIWIT PHARM AJENAT PHARMS XGEN PHARMS CHINA RESOURCES ALKEM LABS LTD GRANULES HAINAN POLY PHARM KNACK
Active Ingredient: LEVETIRACETAM

LEVETIRACETAM Approval History

Loading approval history...

What LEVETIRACETAM Treats

3 indications

LEVETIRACETAM is approved for 3 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Partial-onset seizures
  • Myoclonic seizures in patients with juvenile myoclonic epilepsy
  • Primary generalized tonic-clonic seizures in patients with idiopathic generalized epilepsy
Source: FDA Label

Drugs Similar to LEVETIRACETAM

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AFINITOR DISPERZ
EVEROLIMUS
1 shared
Novartis
Shared indications:
Partial-Onset Seizures
APTIOM
ESLICARBAZEPINE ACETATE
1 shared
SUMITOMO PHARMA AM
Shared indications:
Partial-Onset Seizures
BRIVARACETAM
BRIVARACETAM
1 shared
Aurobindo Pharma
Shared indications:
Partial-Onset Seizures
BRIVIACT
BRIVARACETAM
1 shared
UCB INC
Shared indications:
Partial-Onset Seizures
EPRONTIA
TOPIRAMATE
1 shared
AZURITY
Shared indications:
Partial-Onset Seizures
ESLICARBAZEPINE ACETATE
ESLICARBAZEPINE ACETATE
1 shared
Dr. Reddy's
Shared indications:
Partial-Onset Seizures
FYCOMPA
PERAMPANEL
1 shared
CATALYST PHARMS
Shared indications:
Partial-Onset Seizures
KEPPRA
LEVETIRACETAM
1 shared
UCB INC
Shared indications:
Partial-Onset Seizures
KEPPRA XR
LEVETIRACETAM
1 shared
UCB INC
Shared indications:
Partial-Onset Seizures
LAMICTAL
LAMOTRIGINE
1 shared
GSK
Shared indications:
Partial-Onset Seizures
LAMICTAL ODT
LAMOTRIGINE
1 shared
GSK
Shared indications:
Partial-Onset Seizures
LAMICTAL XR
LAMOTRIGINE
1 shared
GSK
Shared indications:
Partial-Onset Seizures
LAMOTRIGINE
LAMOTRIGINE
1 shared
ZYDUS PHARMS USA
Shared indications:
Partial-Onset Seizures
LEVETIRACETAM IN SODIUM CHLORIDE
LEVETIRACETAM
1 shared
CAPLIN
Shared indications:
Partial-Onset Seizures
MOTPOLY XR
LACOSAMIDE
1 shared
AUCTA
Shared indications:
Partial-Onset Seizures
OXTELLAR XR
OXCARBAZEPINE
1 shared
SUPERNUS PHARMS
Shared indications:
Partial-Onset Seizures
PERAMPANEL
PERAMPANEL
1 shared
MSN
Shared indications:
Partial-Onset Seizures
QUDEXY XR
TOPIRAMATE
1 shared
UPSHER SMITH LABS
Shared indications:
Partial-Onset Seizures
SUBVENITE
LAMOTRIGINE
1 shared
OWP PHARMS
Shared indications:
Partial-Onset Seizures
TOPAMAX
TOPIRAMATE
1 shared
Johnson & Johnson
Shared indications:
Partial-Onset Seizures
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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.

LEVETIRACETAM FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older Levetiracetam 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 Levetiracetam tablets are 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 L...

Want competitive intelligence?

See who's developing similar drugs and track their progress

View Pipeline Dashboard

Data Sources

FDA Approval: ANDA078918 → Label: DailyMed → Trials: ClinicalTrials.gov →

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