NDAORALSOLUTION
Approved
Apr 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
3
Data completeness
6/8 — Strong
ERMEZA (levothyroxine sodium) by Viatris (2) is synthesis. First approved in 2022.
Drug data last refreshed 2h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ERMEZA is an oral solution formulation of levothyroxine sodium, a synthetic thyroid hormone replacement indicated for hypothyroidism and other thyroid disorders. It works by supplementing deficient thyroid hormone levels, with T3 and T4 binding to thyroid receptor proteins in cell nuclei to modulate gene transcription and metabolic processes. Approximately 80% of T3, the physiologically active form, is derived from peripheral deiodination of T4.
$0.023BPart D
Peak8.7 years to LOEProduct is in peak commercial phase with established market presence; team size likely stable to growing as brand consolidates market position in hypothyroidism management.
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.