NDAORALSOLUTION
Approved
Apr 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
3
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 (8)
hypothyroidism during the recovery phase of subacute thyroiditisincluding neonatesan adjunct to surgeryradioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancerfor: • Hypothyroidism:secondary (pituitary)tertiary (hypothalamic) congenitalacquired hypothyroidism
Clinical Trials (3)
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
Loss of Exclusivity
LOE Date
Feb 27, 2035
109 months away
Patent Expiry
Feb 27, 2035
Patent Records (1)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 9345772 | Feb 27, 2035 | Product | — |