Claims for Patent: 12,023,328

Summary for Patent: 12,023,328

Title:	Compositions of 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluoropheyl)-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:	US18/518,110
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 12,023,328
Patent Claims:	1. A method of treating gastrointestinal stromal tumors in a patient in need thereof, comprising administering to the patient, once daily, one or more pharmaceutically acceptable tablets for orally delivering a compound represented by Formula (I): wherein each pharmaceutically acceptable tablet comprises: (i) a solid dispersion and one or more pharmaceutically acceptable carriers, wherein the solid dispersion comprises: (a) 50 mg of the compound wherein the compound is present in amorphous form; and (b) hydroxypropyl methyl cellulose acetate succinate; and (ii) a compound represented by Formula (III): in an amount equal to or less than about 10% by weight based on the total weight of the pharmaceutically acceptable tablet. 2. The method of claim 1, wherein each pharmaceutically acceptable tablet comprises aniline in an amount equal to or less than about 2% by weight based on the total weight of the pharmaceutically acceptable tablet. 3. The pharmaceutical composition of claim 1, wherein each pharmaceutically acceptable tablet comprises 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 pharmaceutically acceptable tablet. 4. The pharmaceutical composition of claim 1, wherein each pharmaceutically acceptable tablet comprises 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 pharmaceutically acceptable tablet. 5. The method of claim 1, wherein each pharmaceutically acceptable tablet comprises: (i) aniline in an amount equal to or less than about 2% by weight based on the total weight of the pharmaceutically acceptable tablet; (ii) a compound represented by Formula (II): in an amount equal to or less than about 0.40% by weight based on the total weight of the pharmaceutically acceptable tablet; and (iii) diphenyl urea in an amount equal to or less than about 0.2% by weight based on the total weight of the pharmaceutically acceptable tablet. 6. The method of claim 1, wherein each pharmaceutically acceptable tablet comprises: (i) aniline in an amount equal to or less than about 2% by weight based on the total weight of the pharmaceutically acceptable tablet; (ii) a compound represented by Formula (II): in an amount equal to or less than about 2% by weight based on the total weight of the pharmaceutically acceptable tablet; and (iii) diphenyl urea in an amount equal to or less than about 0.2% by weight based on the total weight of the pharmaceutically acceptable tablet. 7. A method of treating gastrointestinal stromal tumors in a patient in need thereof, comprising administering to the patient, once daily, one or more pharmaceutically acceptable tablets for oral delivery, wherein each pharmaceutically acceptable tablet comprises: (i) a solid dispersion and one or more pharmaceutically acceptable carriers, wherein the solid dispersion comprises: (a) an amorphous form of a compound represented by Formula (I): (b) hydroxypropyl methyl cellulose acetate succinate; and (ii) a compound represented by Formula (III): in an amount equal to or less than about 10% by weight based on the total weight of the pharmaceutically acceptable tablet. 8. The method of claim 7, wherein each pharmaceutically acceptable tablet comprises aniline in an amount equal to or less than about 2% by weight based on the total weight of the pharmaceutically acceptable tablet. 9. The pharmaceutical composition of claim 7, wherein each pharmaceutically acceptable tablet comprises 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 pharmaceutically acceptable tablet. 10. The pharmaceutical composition of claim 7, wherein each pharmaceutically acceptable tablet comprises 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 pharmaceutically acceptable tablet. 11. The method of claim 7, wherein each pharmaceutically acceptable tablet comprises: (i) aniline in an amount equal to or less than about 0.3% by weight based on the total weight of the pharmaceutically acceptable tablet; (ii) a compound represented by Formula (II): in an amount equal to or less than about 0.40% by weight based on the total weight of the pharmaceutically acceptable tablet; and (iii) diphenyl urea in an amount equal to or less than about 0.2% by weight based on the total weight of the pharmaceutically acceptable tablet. 12. The method of claim 7, wherein each pharmaceutically acceptable tablet comprises: (i) aniline in an amount equal to or less than about 2% by weight based on the total weight of the pharmaceutically acceptable tablet; (ii) a compound represented by Formula (II): in an amount equal to or less than about 2% by weight based on the total weight of the pharmaceutically acceptable tablet; and (iii) diphenyl urea in an amount equal to or less than about 0.2% by weight based on the total weight of the pharmaceutically acceptable tablet.