NDAORALFOR SUSPENSIONPriority Review
Approved
Aug 2015
Lifecycle
Post-LOE
Competitive Pressure
35/100
Clinical Trials
4
Mechanism of Action
TPO-receptor agonist that interacts with the transmembrane domain of the human TPO-receptor (also known as cMpl) and initiates signaling cascades that induce proliferation and differentiation of megakaryocytes leading to increased platelet production.
Indications (10)
thrombocytopenia in adultolder with persistentchronic immune thrombocytopenia (ITP)immunoglobulinssplenectomythrombocytopenia in patients with chronic hepatitis C to allow the initiationmaintenance of interferon-based therapycombination with standard immunosuppressive therapy (IST) for the first-line treatment of adultolder with severe aplastic anemiahepatitis C
Clinical Trials (4)
Bioequivalence Study of Eltrombopag Olamine Tablets in Healthy Subjects in the Fed State
Started Mar 2023
Bioequivalence Test of Eltrombopag Olamine Tablets in Humans Under Fasting State
Started Jan 2020
Study Assessed the Safety and Efficacy of Eltrombopag in Chinese Refractory or Relapsed Severe Aplastic Anemia (SAA) Subjects.
Started Dec 2019
20 enrolled
Aplastic Anemia
Eltrombopag Olamine in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia
Started May 2012
10 enrolled
Adult Acute Basophilic LeukemiaAdult Acute Eosinophilic LeukemiaAdult Acute Megakaryoblastic Leukemia (M7)+14 more
Loss of Exclusivity
LOE Date
Jan 13, 2026
2 months ago
Patent Expiry
Jan 13, 2026
Patent Records (2)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 7547719 | Jul 13, 2025Expired | SubstanceProduct | U-1306 |
| 7547719*PED | Jan 13, 2026Expired | — |