NDAORALSUSPENSIONPriority Review
Approved
Jul 1993
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
5/8 — Partial
Priority Review
FELBATOL (felbamate) by Viatris (2) is mechanism of action the mechanism by which felbamate exerts its anticonvulsant activity is unknown, but in animal test systems designed to detect anticonvulsant activity, felbamate has properties in common with other marketed anticonvulsants. Approved for epilepsy, anemia. First approved in 1993.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FELBATOL (felbamate) is an oral anti-epileptic agent approved in 1993 for treating epilepsy and anemia. Its mechanism of action remains incompletely understood, but it exhibits anticonvulsant properties across multiple animal seizure models and interacts as an antagonist at the strychnine-insensitive glycine recognition site of the NMDA receptor. The drug is available as an oral suspension and represents a unique pharmacological profile among marketed anticonvulsants.
$7MPart D
LOE ApproachingDeclining
Limited commercial trajectory with 2,175 Part D claims in 2023 and approaching loss of exclusivity signals a contracting team focused on legacy product management.
Mechanism of Action
Mechanism of Action The mechanism by which felbamate exerts its anticonvulsant activity is unknown, but in animal test systems designed to detect anticonvulsant activity, felbamate has properties in common with other marketed anticonvulsants. Felbamate is effective in mice and rats in the maximal…
Pharmacologic Class:
Anti-epileptic Agent
Indications (2)
Worked on FELBATOL at Viatris (2)? Share your interview experience or compensation data (+7 days Pro)
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.