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 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SPRITAM is a first-in-class orally disintegrating tablet formulation of levetiracetam, a small-molecule antiepileptic agent approved in 2015. It works by binding to the synaptic vesicle protein SV2A, which may regulate vesicle exocytosis and reduce seizure activity. The drug is indicated for partial-onset seizures and is used as monotherapy or adjunctive therapy in patients who may have difficulty swallowing traditional tablets.
$0.001BPart D
Peak7.7 years to LOEProduct is in peak lifecycle phase with minimal Part D spending and claim volume, indicating a niche market position with a focused, efficient commercial team.
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.