NDAORALSOLUTION
Approved
Dec 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
3
Data completeness
6/8 — Strong
TIROSINT-SOL (levothyroxine sodium) by Pfizer is synthesis. Approved for hypothyroidism, congenital hypothyroidism. First approved in 2016.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TIROSINT-SOL is an oral liquid solution of levothyroxine sodium approved for hypothyroidism and congenital hypothyroidism. It works by providing exogenous thyroid hormone that binds to thyroid receptors in cell nuclei, activating gene transcription and restoring metabolic function. The majority of physiologic effects are produced by T3, which is derived from peripheral conversion of the T4 provided by this product.
$0.002BPart D
Peak18.4 years to LOEProduct is at peak lifecycle stage with modest Part D spending of $2M; small team focused on niche positioning within crowded levothyroxine market.
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.