NDAORALSOLUTIONPriority Review
Approved
Apr 1986
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
Priority Review
CARNITOR (levocarnitine) by Leadiant Biosciences is clinical pharmacology carnitor (levocarnitine) is a naturally occurring substance required in mammalian energy metabolism. First approved in 1986.
Drug data last refreshed 4h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CARNITOR (levocarnitine) is a naturally occurring amino acid derivative that facilitates long-chain fatty acid entry into mitochondria for energy production. It is indicated for primary and secondary carnitine deficiency, including inborn errors of metabolism such as glutaric aciduria II, methylmalonic aciduria, propionic acidemia, and medium-chain fatty acyl-CoA dehydrogenase deficiency. The drug works by promoting excretion of toxic acylCoA compounds and reducing metabolic autointoxication in patients with fatty acid oxidation disorders.
$0.056BPart D
LOE ApproachingProduct approaching loss of exclusivity with modest commercial footprint; brand team likely focused on lifecycle management and transition planning rather than expansion.
Mechanism of Action
CLINICAL PHARMACOLOGY CARNITOR (levocarnitine) is a naturally occurring substance required in mammalian energy metabolism. It has been shown to facilitate long-chain fatty acid entry into cellular mitochondria, thereby delivering substrate for oxidation and subsequent energy production. Fatty acids…
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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.