NDAORALTABLET
Approved
Aug 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
6/8 — Strong
UNITHROID (levothyroxine sodium) by Pfizer is clinical pharmacology thyroid hormone synthesis and secretion is regulated by the hypothalamic-pituitary-thyroid axis. Approved for hypothyroidism, congenital hypothyroidism. First approved in 2000.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
UNITHROID (levothyroxine sodium) is an oral tablet that replaces or supplements thyroid hormone in patients with hypothyroidism and congenital hypothyroidism. It works by restoring circulating T4 levels, which are peripherally converted to the active T3 form to regulate cellular respiration, thermogenesis, and protein metabolism. The drug's mechanism involves binding thyroid hormone receptors in cell nuclei to activate gene transcription and restore normal metabolic function.
$0.003BPart D
LOE ApproachingUNITHROID is a mature, stable legacy brand approaching loss of exclusivity with modest spending ($3M Part D), signaling small brand teams focused on managed transition and niche positioning.
Mechanism of Action
CLINICAL PHARMACOLOGY Thyroid hormone synthesis and secretion is regulated by the hypothalamic-pituitary-thyroid axis. Thyrotropin-releasing hormone (TRH) released from the hypothalamus stimulates secretion of thyrotropin-stimulating hormone, TSH, from the anterior pituitary. TSH, in turn, is the…
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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.