NDAINTRAVENOUSSOLUTION1 Generic Approved
Approved
May 2021
Lifecycle
Peak
Competitive Pressure
15/100
Clinical Trials
7
Data completeness
4/8 — Partial
Drug data last refreshed 17h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Levothyroxine Sodium is a synthetic thyroid hormone replacement therapy administered intravenously as a solution. It is used to treat hypothyroidism and other thyroid hormone deficiency conditions. The drug works by supplementing or replacing insufficient endogenous thyroid hormone production.
Peak9.7 years to LOE
Product is at peak commercial phase with moderate competitive pressure (30), suggesting stable revenue streams and established field teams.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
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
Fasting Study of Levothyroxine Sodium Tablets 300 mcg to Synthroid® Tablets 300 mcg
Started Mar 2007
33 enrolled
Healthy
Fasting Study of Levothyroxine Sodium Tablets 300 μg to Levothroid® Tablets 300 μg
Started Aug 2005
32 enrolled
Healthy
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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.