NDAORALSOLUTIONPriority Review
Approved
Apr 1986
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
Priority Review
CARNITOR SF (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 10h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CARNITOR SF (levocarnitine) is an oral solution containing a naturally occurring amino acid derivative essential for cellular energy metabolism. It facilitates long-chain fatty acid entry into mitochondria for oxidation and energy production, primarily treating primary and secondary carnitine deficiency. The drug is indicated for patients with inborn errors of metabolism (glutaric aciduria II, methylmalonic aciduria, propionic acidemia, medium-chain fatty acyl-CoA dehydrogenase deficiency) where it clears toxic acylCoA compounds by forming excretable acylcarnitine.
$0.007BPart D
LOE ApproachingStable
Declining Part D utilization ($7K in 2023, only 34 claims) signals a mature, niche market with minimal commercial expansion opportunities.
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.