NDAORALSOLUTION
Approved
Apr 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
3
Data completeness
7/8 — Comprehensive
ERMEZA (levothyroxine sodium) by Viatris (2) is synthesis. Approved for hypothyroidism, congenital hypothyroidism. First approved in 2022.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ERMEZA is an oral levothyroxine sodium solution approved in 2022 for treating hypothyroidism and congenital hypothyroidism. The drug works by replacing deficient thyroid hormone, allowing T4 to diffuse into cell nuclei and bind thyroid receptor proteins, activating gene transcription and protein synthesis. Approximately 80% of T4 is peripherally converted to the more potent T3, restoring normal metabolic function.
$0.023BPart D
Peak8.8 years to LOEERMEZA is in peak commercial phase with modest Medicare spending; the team likely remains lean given minimal Part D presence and zero competitive pressure from alternatives.
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 (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.