NDAINTRAVENOUSSOLUTION1 Generic Approved
Approved
May 2021
Lifecycle
Peak
Competitive Pressure
15/100
Clinical Trials
3
Data completeness
6/8 — Strong
LEVOTHYROXINE SODIUM (levothyroxine sodium) by Hikma is synthesis. Approved for hypothyroidism, congenital hypothyroidism. First approved in 2021.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Levothyroxine sodium is a synthetic thyroid hormone replacement therapy used to treat hypothyroidism and congenital hypothyroidism. It works by diffusing into cell nuclei and binding to thyroid receptor proteins, activating gene transcription and protein synthesis to restore normal metabolic function. The drug is administered intravenously as a solution, representing a unique formulation among predominantly oral competitors.
Peak10.2 years to LOE
Recent IV formulation launch (2021) positions Hikma in a niche segment with differentiated delivery, but faces moderate competitive pressure from 8+ established oral alternatives.
Mechanism of Action
synthesis. Triiodothyronine (T 3 ) and levothyroxine (T 4 ) 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…
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.