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 (2) 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 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Leucovorin calcium is a reduced folate cofactor that counteracts the toxic effects of folic acid antagonists like methotrexate and enhances the therapeutic effects of fluoropyrimidines such as 5-fluorouracil in cancer therapy. It does not require enzymatic reduction and is rapidly metabolized to active metabolites that participate in one-carbon transfer reactions essential for DNA synthesis and repair. This oral tablet formulation is used as an adjunctive agent in cancer regimens to optimize efficacy and reduce toxicity.
LOE Approaching
As a mature generic with approaching loss of exclusivity, the brand team is likely focused on cost management and operational efficiency rather than growth initiatives.
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.