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Last Updated: December 16, 2025

Claims for Patent: 11,612,591

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Summary for Patent: 11,612,591

Title:	Compositions of 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluorophenyl)-3-phenylurea
Abstract:	Provided herein are low impurity compositions comprising a compound represented by Formula (I):which are useful in the treatment of disorders related to the activity of the c-KIT and PDGFRα kinases, and oncogenic forms thereof.
Inventor(s):	Michael D. Kaufman, Scott Bone, Corey Bloom, Fred Jordan
Assignee:	Deciphera Pharmaceuticals LLC
Application Number:	US17/735,820
Patent Claims:	1. A pharmaceutical composition for orally delivering 50 mg of a compound represented by Formula (I): comprising: a solid dispersion having 50 mg of the compound wherein the compound is present in amorphous form, and hydroxypropyl methyl cellulose acetate succinate; about 25-45% by weight of a bulking agent based on the total amount of the pharmaceutical composition; about 25-45% by weight of a filler based on the total amount of the pharmaceutical composition; and wherein aniline is present in an amount equal to or less than about 5% by weight based on the total weight of the pharmaceutical composition. 2. The pharmaceutical composition of claim 1, wherein aniline is present in an amount equal to or less than about 3% by weight based on the total weight of the pharmaceutical composition. 3. The pharmaceutical composition of claim 1, wherein aniline is present in an amount equal to or less than about 2% by weight based on the total weight of the pharmaceutical composition. 4. The pharmaceutical composition of claim 1, wherein aniline is present in an amount equal to or less than about 1% by weight based on the total weight of the pharmaceutical composition. 5. The pharmaceutical composition of claim 1, wherein aniline is present in an amount equal to or less than about 0.5% by weight based on the total weight of the pharmaceutical composition. 6. A pharmaceutical composition comprising: a) a solid dispersion comprising: a pharmaceutically acceptable polymer; and 50 mg of an amorphous form of a compound represented by Formula (I): and b) one or more pharmaceutically acceptable carriers; wherein: aniline is present in an amount equal to or less than about 1.5% by weight based on the total weight of the pharmaceutical composition, wherein the pharmaceutically acceptable polymer is hydroxypropyl methyl cellulose acetate succinate. 7. The pharmaceutical composition of claim 6, wherein aniline is present in an amount equal to or less than about 1.0% by weight based on the total weight of the pharmaceutical composition. 8. The pharmaceutical composition of claim 6, wherein aniline is present in an amount equal to or less than about 0.5% by weight based on the total weight of the pharmaceutical composition. 9. A pharmaceutical composition comprising: a) a solid dispersion comprising: a pharmaceutically acceptable polymer; and 50 mg of an amorphous form of a compound represented by Formula (I): and b) one or more pharmaceutically acceptable carriers; wherein: a compound represented by Formula (III): is present in an amount equal to or less than about 10% by weight based on the total weight of the pharmaceutical composition, wherein the pharmaceutically acceptable polymer is hydroxypropyl methyl cellulose acetate succinate. 10. The pharmaceutical composition of claim 9, wherein the compound of Formula (III) is present in an amount equal to or less than about 3% by weight based on the total weight of the pharmaceutical composition. 11. The pharmaceutical composition of claim 9, wherein the compound of Formula (III) is present in an amount equal to or less than about 1% by weight based on the total weight of the pharmaceutical composition.

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