Lamictal
An oral medication used to prevent seizures and manage mood episodes in bipolar disorder.
Where Lamotrigine is approved
All regulators →Of the three regulators tracked here, the first to approve Lamotrigine was Canada, on 21 Nov 1994. It is approved in 2 of the 3 regulators tracked here.
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.
Lamotrigine patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Lamotrigine, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 5 listed patents; the last listed expires 29 May 2040 (US 11596634).
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 Lamotrigine
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 Lamotrigine works
All drug targets →- Sodium channel alpha subunit blocker BlockerTarget: Sodium channel alpha subunit✓ In ChEMBL and the Guide to Pharmacology
- Focal impaired awareness seizurePhase 3
- Focal-onset seizurePhase 3
- MyotoniaPhase 3
- Typical absence seizurePhase 3
- Alcohol dependencePhase 3
- Bipolar II disorderPhase 3
- Childhood absence epilepsyPhase 3
- Depressive disorderPhase 3
- Eating disorderPhase 3
- Mood disorderPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL741, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 2622, 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 Lamotrigine
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Lamotrigine. 2 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Newer drugs for epilepsy in children NICE TA79 | Recommended | 28 Apr 2004 | Current |
| 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 Lamotrigine
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 39 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- 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 Lamotrigine
- ATC code
- N03AX09
- ChEMBL
- CHEMBL741
- DrugBank
- DB00555
- PubChem CID
- 3878
- CAS number
- 84057-84-1
- FDA UNII
- U3H27498KS
- Wikidata
- Q410346
- Wikipedia
- Lamotrigine
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 Lamictal is used for
LAMICTAL is indicated for: Epilepsy—adjunctive therapy in patients aged 2 years and older: • partial-onset seizures. • primary generalized tonic-clonic (PGTC) seizures. • generalized seizures of Lennox-Gastaut syndrome. ( 1.1 ) Epilepsy—monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug. ( 1.1 ) Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. ( 1.2 ) Limitations of Use: Treatment of acute manic or mixed episodes is not recommended. Effectiveness of LAMICTAL in the acute treatment of mood episodes has not been established. 1.1 Epilepsy Adjunctive Therapy LAMICTAL is in…
How it works
12.1 Mechanism of Action The precise mechanism(s) by which lamotrigine exerts its anticonvulsant action are unknown. In animal models designed to detect anticonvulsant activity, lamotrigine was effective in preventing seizure spread in the maximum electroshock (MES) and pentylenetetrazol (scMet) tests, and prevented seizures in the visually and electrically evoked after-discharge (EEAD) tests for antiepileptic activity. Lamotrigine also displayed inhibitory properties in the kindling model in rats both during kindling development and in the fully kindled state. The relevance of these models to human epilepsy, however, is not known. One proposed mechanism of action of lamotrigine, the releva…
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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.