NDAORALTABLET, EXTENDED RELEASE2 Generics Approved
Approved
Sep 2008
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
20
Data completeness
5/8 — Partial
Drug data last refreshed 6h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KEPPRA XR is an extended-release oral tablet formulation of levetiracetam, a small-molecule antiepileptic agent used to treat seizure disorders. The drug is indicated for adjunctive therapy in epilepsy and works through mechanisms that reduce neuronal hyperexcitability, though its precise pharmacological mechanism remains incompletely understood. It is widely used across multiple seizure types in both adult and pediatric populations.
$27MPart D
LOE ApproachingDeclining
2.2 years to LOEProduct is in late-stage commercial maturity with patent expiration in 2.3 years, signaling transition from growth-oriented to defense and transition planning for brand teams.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Investigate JNJ-40411813 in Combination With Levetiracetam or Brivaracetam in Epilepsy
Started May 2021
110 enrolled
Focal Onset Seizures
An Investigation of Levetiracetam in Alzheimer's Disease
Started Oct 2018
8 enrolled
Alzheimer DiseaseEpilepsy
A Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric Epileptic Subjects Ranging From 1 Month to Less Than 4 Years of Age
Started Nov 2017
38 enrolled
Partial Seizures
Effects of Augmented Renal Clearance on Pharmacokinetic and Pharmacodynamic Properties of Levetiracetam in Subarachnoid Hemorrhage
Started Jan 2016
15 enrolled
Subarachnoid Hemorrhage
A Brain Imaging Study With Positron Emission Tomography and the Radiotracer [11C]UCB-J to Estimate How Fast Brivaracetam and Levetiracetam Enter the Brain in Healthy Volunteers
Started Nov 2015
13 enrolled
Healthy Volunteers
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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.