NDAORALTABLET
Approved
May 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
5/8 — Partial
LEVOXYL (levothyroxine sodium) by Pfizer is synthesis. First approved in 2001.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LEVOXYL is an oral tablet formulation of levothyroxine sodium, a synthetic thyroid hormone that replaces or supplements endogenous thyroid hormone. It treats hypothyroidism across multiple etiologies—primary, secondary, tertiary, congenital, and acquired—as well as radioiodine-induced hypothyroidism in thyroid cancer management. The drug works by binding thyroid hormone receptors in cell nuclei to activate gene transcription, with approximately 80% of physiological activity derived from peripheral conversion of T4 to T3.
$5.0MPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Part D spending signals consolidating commercial teams and shift toward lifecycle management and generic transition planning.
Mechanism of Action
synthesis. Triiodothyronine (T3) and L-thyroxine (T4) diffuse into the cell nucleus and bind to thyroid receptor proteins attached to DNA. This hormone nuclear receptor complex activates gene transcription and synthesis of messenger RNA and cytoplasmic proteins. The physiological actions of thyroid…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Bioequivalence of Two Formulations of Levothyroxine Sodium 200 Micrograms (mcg) Under Tablet Form
Started Jun 2019
72 enrolled
Healthy
Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors
Started Jul 2018
66 enrolled
Hypothyroidism;Postablative
Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation
Started Jul 2013
101 enrolled
Hypothyroidism
Career Relevance
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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.