NDAORALTABLETPriority Review
Approved
Mar 1954
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
5/8 — Partial
Priority Review
MYSOLINE (primidone) by Bausch + Lomb is actions mysoline raises electro- or chemoshock seizure thresholds or alters seizure patterns in experimental animals. Approved for anti-epileptic agent [epc]. First approved in 1954.
Drug data last refreshed 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MYSOLINE (primidone) is an oral anti-epileptic agent approved in 1954 for seizure management. It is a small-molecule barbiturate derivative that reduces seizure frequency across multiple epilepsy types. The drug works through central nervous system depression and modulation of neuronal excitability.
$14MPart D
LOE ApproachingDeclining
Product is approaching loss of exclusivity with minimal commercial momentum; expect contraction in brand team size and shift toward specialty or niche positioning.
Mechanism of Action
ACTIONS MYSOLINE raises electro- or chemoshock seizure thresholds or alters seizure patterns in experimental animals. The mechanism(s) of primidone’s antiepileptic action is not known. Primidone per se has anticonvulsant activity as do its two metabolites, phenobarbital and phenylethylmalonamide…
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 (1)
Bioequivalence Study of Primidone Tablets 50 mg of Dr. Reddy's Under Fasting Conditions
Started Aug 2006
24 enrolled
Healthy
Career Relevance
Roles on MYSOLINE represent legacy portfolio management rather than growth careers; team sizes are typically small and focused on regulatory maintenance, price protection, and generic competition management. Career mobility depends on organizational downsizing tolerance and ability to transition skills to growth-stage products.
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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.