NDAORALCAPSULE
Approved
Oct 2006
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
4
Data completeness
5/8 — Partial
TIROSINT (levothyroxine sodium) by Pfizer is synthesis. First approved in 2006.
Drug data last refreshed 1h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TIROSINT is a Pfizer-approved levothyroxine sodium capsule for oral administration that replaces or supplements insufficient thyroid hormone production. It works by providing exogenous T4, which is peripherally converted to the active T3 form to restore normal metabolic function. The drug is indicated for hypothyroidism and thyroid hormone replacement therapy.
$0.015BPart D
PeakStable
18.3 years to LOEPeak lifecycle status with $15M Part D spending indicates stable mature franchise requiring maintenance-focused commercial teams rather than growth-stage expansion.
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 (4)
Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH)
Started Jan 2022
34 enrolled
Congenital Hypothyroidism
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
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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.