Keppra
An oral or intravenous medication used to treat seizures in adults and children with epilepsy.
Where Levetiracetam is approved
All regulators →Of the three regulators tracked here, the first to approve Levetiracetam was the US, on 30 Nov 1999. It is approved in 3 of the 3 regulators tracked here.
- 1 EU safety letter (DHPC), latest: medication error for Keppra, 16 Dec 2024
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Levetiracetam patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Levetiracetam, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 5 listed patents; the last listed expires 14 Mar 2034 (US 9339489).
Reproduced from the FDA Orange Book and Purple Book (checked 12 Oct 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Levetiracetam
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Levetiracetam works
All drug targets →- Synaptic vesicle glycoprotein 2A modulator ModulatorTarget: SV2A synaptic vesicle glycoprotein 2A✓ In ChEMBL and the Guide to Pharmacology
- Voltage-gated N-type calcium channel alpha-1B subunit blocker BlockerTarget: CACNA1B calcium voltage-gated channel subunit alpha1 BChEMBL only
- EncephalopathyPhase 3
- Focal-onset seizurePhase 3
- Generalized non-motor (absence) seizurePhase 3
- Generalized-onset seizurePhase 3
- Alcohol withdrawalPhase 3
- Focal epilepsyPhase 3
- Idiopathic generalized epilepsyPhase 3
- Infantile epileptic encephalopathyPhase 3
- Movement disorderPhase 3
- Status epilepticusPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1286, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 6826, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Levetiracetam
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Levetiracetam. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Newer drugs for epilepsy in adults NICE TA76 | Recommended | 24 Mar 2004 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Levetiracetam
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 45 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Keppra, Levetiracetam Accord (generic), Levetiracetam Actavis (generic), Levetiracetam Actavis Group (generic), Levetiracetam Hospira (generic), Levetiracetam Sun (generic), Levetiracetam Teva (generic), Levetiracetam ratiopharm (generic) and 1 moreEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Levetiracetam
- ATC code
- N03AX14
- ChEMBL
- CHEMBL1286
- DrugBank
- DB01202
- PubChem CID
- 5284583
- CAS number
- 102767-28-2
- FDA UNII
- 44YRR34555
- Wikidata
- Q417227
- Wikipedia
- Levetiracetam
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Keppra is used for
KEPPRA is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) KEPPRA is indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2 ) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3 ) 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 adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. 1.3 Primary Generalized Tonic-Clonic Seizures KEPPRA is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures i…
How it works
12.1 Mechanism of Action The precise mechanism(s) by which levetiracetam exerts its antiepileptic effect is unknown. A saturable and stereoselective neuronal binding site in rat brain tissue has been described for levetiracetam. Experimental data indicate that this binding site is the synaptic vesicle protein SV2A, thought to be involved in the regulation of vesicle exocytosis. Although the molecular significance of levetiracetam binding to SV2A is not understood, levetiracetam and related analogs showed a rank order of affinity for SV2A which correlated with the potency of their antiseizure activity in audiogenic seizure-prone mice. These findings suggest that the interaction of levetirace…
Compare Keppra with
Explore more
How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 10 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.