NDAORALCAPSULE
Approved
Nov 1976
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
SODIUM IODIDE I 131 (sodium iodide i-131) by CIS Pharma is sodium-iodide symporter (nis) protein, in thyroid follicular cells. Approved for hyperthyroidism, selected cases of carcinoma of the thyroid. First approved in 1976.
Drug data last refreshed 23h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Sodium Iodide I-131 is an oral radioactive iodine therapeutic that treats hyperthyroidism and selected thyroid carcinomas by targeting the sodium-iodide symporter in thyroid follicular cells. The drug concentrates iodide up to 50 times higher than plasma levels, where it is oxidized and incorporated into thyroglobulin; beta emissions from I-131 provide the therapeutic destructive effect on thyroid tissue.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100); team focus likely shifting toward lifecycle management and generic transition planning.
Mechanism of Action
sodium-iodide symporter (NIS) protein, in thyroid follicular cells. Iodide is concentrated in follicular cells to levels up to 50 times higher than in the plasma. Iodide is metabolically oxidized by thyroid peroxidase to iodinium (I) which in turn iodinates tyrosine residues of thyroglobulin (tri…
Indications (2)
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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.