NDAORALTABLET, EXTENDED RELEASE2 Generics Approved
Approved
May 2009
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
LAMICTAL XR (lamotrigine) by GSK is organic cation transporter 2 inhibitors [moa]. Approved for anti-epileptic agent [epc]. First approved in 2009.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LAMICTAL XR is an extended-release oral tablet formulation of lamotrigine, an anti-epileptic agent approved in 2009. It treats seizure disorders by inhibiting organic cation transporter 2, reducing abnormal neuronal firing. The product serves patients requiring once-daily seizure management with sustained drug exposure.
$53MPart D
LOE ApproachingDeclining
2.5 years to LOEProduct faces imminent loss of exclusivity in 2.6 years; brand teams should expect declining market share and consolidation of commercial resources.
Mechanism of Action
Organic Cation Transporter 2 Inhibitors
Pharmacologic Class:
Anti-epileptic Agent
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
Started Oct 2025
424 enrolled
ManiaBipolar Disorder
A Study to Evaluate the Effects of Lithium, Valproic Acid, and Lamotrigine on the Pharmacokinetics of KarXT and Effects of KarXT on the Pharmacokinetics of Lithium, Valproic Acid, and Lamotrigine in Healthy Participants
Started Dec 2024
133 enrolled
Healthy Volunteers
A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine
Started Dec 2020
40 enrolled
Healthy
Ketamine-Induced Brain Changes and Their Modulation by Lamotrigine
Started Mar 2020
75 enrolled
Emotions
A Study to Evaluate the Effect of AG-881 on the Pharmacokinetics of a Single Dose of Lamotrigine in Healthy Adults
Started Jul 2019
22 enrolled
Healthy Participants
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.