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Last Updated: December 12, 2025

Claims for Patent: 11,072,586


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Summary for Patent: 11,072,586
Title:Solid state forms of eltrombopag choline
Abstract:Solid state forms of Eltrombopag choline, processes for preparation thereof and pharmaceutical compositions thereof are disclosed.
Inventor(s):Sharma Vijay Hariprasad, Nasir Ali Shafakat Ali, Joshi Ashutosh Vijay, Parven Kumar Luthra, Anantha Rajmohan MUTHUSAMY, Amit Singh, Rajesh Sadanand Bate, Sadanand Hardeo Maurya
Assignee: Assia Chemical Industries Ltd
Application Number:US16/753,363
Patent Claims: 1. A solid state form of Eltrombopag choline selected from: A. crystalline form A, which is characterized by data selected from one or more of the following: i. an XRPD pattern having peaks at 11.3, 14.7, 15.4, 16.0 and 24.1 degrees-2-theta±0.2 degrees-2-theta; ii. an XRPD pattern as depicted in FIG. 1; and combinations of any i-ii, or B. crystalline form B, which is characterized by data selected from one or more of the following: i. an XRPD pattern having peaks at 7.0, 10.2, 13.9, 14.9, 18.3, 21.6 and 26.0 degrees 2-theta±0.2 degrees 2-theta; ii. an XRPD pattern as depicted in FIG. 2; and combinations of any i-ii, or C. crystalline form C, which is characterized by data selected from one or more of the following: i. an XRPD pattern having peaks at 10.9, 14.2, 15.5, 21.9 and 26.9 degrees 2-theta±0.2 degrees 2-theta; ii. an XRPD pattern as depicted in FIG. 5; and combinations of any i-ii.

2. The crystalline Form A of eltrombopag choline according to claim 1, which is characterized by data selected from one or more of the following: i. an XRPD pattern having peaks at 11.3, 14.7, 15.4, 16.0 and 24.1 degrees-2-theta±0.2 degrees-2-theta; ii. an XRPD pattern as depicted in FIG. 1.

3. The crystalline Form A of eltrombopag choline according to claim 1, which is characterized by an XRPD pattern having peaks at 11.3, 14.7, 15.4, 16.0 and 24.1 degrees 2-theta±0.2 degrees 2-theta, and also having one, two, three, four, five, six or seven additional peaks selected from 12.0, 12.7, 14.1, 20.3, 20.9, 24.8 and 27.0 degrees 2-theta±0.2 degrees 2-theta.

4. The crystalline Form B of eltrombopag choline according to claim 1, which is characterized by data selected from one or more of the following: i. an XRPD pattern having peaks at 7.0, 10.2, 13.9, 14.9, 18.3, 21.6 and 26.0 degrees 2-theta±0.2 degrees 2-theta; ii. an XRPD pattern as depicted in FIG. 2.

5. The crystalline Form B of eltrombopag choline according to claim 1, which is characterized an XRPD pattern having peaks at 7.0, 10.2, 13.9, 14.9, 18.3, 21.6 and 26.0 degrees 2-theta±0.2 degrees 2-theta, and also having one, two, three, or four additional peaks selected from 7.4, 16.7, 19.9 and 23.9 degrees 2-theta±0.2 degrees 2-theta.

6. The crystalline Form C of eltrombopag choline according to claim 1, which is characterized by data selected from one or more of the following: i. an XRPD pattern having peaks at 10.9, 14.2, 15.5, 21.9 and 26.9 degrees 2-theta±0.2 degrees 2-theta; ii. an XRPD pattern as depicted in FIG. 5.

7. The crystalline Form C of eltrombopag choline according to claim 1, which is characterized by an XRPD pattern having peaks at 10.9, 14.2, 15.5, 21.9 and 26.9 degrees 2-theta±0.2 degrees 2-theta, and also having one, two, three, or four additional peaks selected from 11.3, 15.0, 21.2, 22.5 and 25.6 degrees 2-theta±0.2 degrees 2-theta.

8. A pharmaceutical composition comprising the crystalline form according to claim 1.

9. Use of the crystalline form according to claim 1 in the preparation of pharmaceutical compositions and/or formulations.

10. A pharmaceutical formulation comprising the crystalline form according to claim 1, and at least one pharmaceutically acceptable excipient.

11. The crystalline form according to claim 1, for use as a medicament.

12. The crystalline form according to claim 1, for use in the treatment of Idiopathic thrombocytopenic purpura, Thrombocytopenia and Aplastic anemia.

13. A method of treating Idiopathic thrombocytopenic purpura, Thrombocytopenia and Aplastic anemia comprising administering a therapeutically effective amount of the crystalline form according to claim 1 to a subject suffering from said condition, or otherwise in need of the treatment.

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