FOLIC ACID
LOE ApproachingNDAORALTABLET
Approved
Jun 1947
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
16
Data completeness
2/8 — Basic
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Folic acid is an oral small-molecule B vitamin (vitamin B9) used to prevent and treat folate deficiency and its complications. It is essential for DNA synthesis, cell division, and methylation reactions. Folic acid works by serving as a cofactor for one-carbon transfer reactions critical to nucleotide synthesis and cellular function.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); expect team consolidation and focus shift toward branded formulations or combination products.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (16)
Folic Acid Supplementation in Calcific Aortic Valve Disease
Started Jul 2023
100 enrolled
Calcification of Aortic ValveAortic Valve Stenosis
Serum Folic Acid Status, Genotyping MTHFR 677C-->T, Plasma Homocysteine, DNA Methylation of IGF2 Gene and Microbiota of the Children: Mother-Children Cohort Study
Started Aug 2018
254 enrolled
Folic Acid Deficiency
Folic Acid and Zinc Supplementation Trial (FAZST)
Started Jun 2013
2,370 enrolled
PregnancyLive BirthSpontaneous Abortion
Trial Evaluating Folic Acid Supplementation by Concomitant Administration of Ethinyl Estradiol + Levonorgestrel
Started Feb 2013
36 enrolled
Contraception
Folic Acid and Vitamin B12 in Young Indian Children
Started Jan 2010
1,000 enrolled
DiarrheaPneumonia
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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.