NDAORALTABLET
Approved
Feb 1980
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
3/8 — Basic
LEUCOVORIN CALCIUM (leucovorin calcium) by Viatris is clinical pharmacology leucovorin is a mixture of the diastereoisomers of the 5-formyl derivative of tetrahydrofolic acid (thf). First approved in 1980.
Drug data last refreshed 2h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Leucovorin calcium is a reduced folate derivative that acts as a cofactor in one-carbon transfer reactions, enabling cells to synthesize nucleotides and amino acids. It counteracts the toxic effects of folic acid antagonists like methotrexate while enhancing the therapeutic efficacy of fluoropyrimidine chemotherapies such as 5-fluorouracil. The drug is used clinically as a rescue agent in high-dose methotrexate therapy and as an adjunct to fluorouracil-based cancer regimens.
LOE Approaching
Product approaching loss of exclusivity with modest competitive pressure (30), indicating transition planning and potential team restructuring on the horizon.
Mechanism of Action
CLINICAL PHARMACOLOGY Leucovorin is a mixture of the diastereoisomers of the 5-formyl derivative of tetrahydrofolic acid (THF). The biologically active compound of the mixture is the (-)- l -isomer, known as Citrovorum factor or (-)-folinic acid. Leucovorin does not require reduction by the enzyme…
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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.