NDAORALTABLET, FOR SUSPENSION
Approved
Jul 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
SPRITAM (levetiracetam) by Molecular Devices is 12. First approved in 2015.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SPRITAM (levetiracetam) is an oral antiepileptic agent approved in 2015 for partial-onset seizures, available as tablets and suspension. The drug works by binding to the synaptic vesicle protein SV2A, thought to regulate neurotransmitter release, though the precise mechanism remains incompletely understood. It is a small molecule with rapid absorption, linear pharmacokinetics, and minimal hepatic metabolism.
$0.001BPart D
Peak7.5 years to LOEProduct is in peak commercial phase with modest Part D spending indicating established market presence but limited growth trajectory for team expansion.
Mechanism of Action
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…
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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.