Last Updated: May 12, 2026

Claims for Patent: 12,509,443

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Summary for Patent: 12,509,443

Title:	CSF-1R inhibitors and methods of use thereof
Abstract:	Provided herein, in part, is a compound of Formula (I) or a hydrate thereof, essentially free of one or more impurities, compositions thereof, and methods of use thereof.
Inventor(s):	Elena Kostik, Ann Gelormini, Michael D. Kaufman
Assignee:	Deciphera Pharmaceuticals LLC
Application Number:	US19/299,588
Patent Claims:	1. A pharmaceutically acceptable oral dosage form, comprising: (i) a dihydrate form of a compound of Formula (I): wherein the dihydrate form is present in the oral dosage form in an amount to provide a dose selected from the group consisting of 2 mg, 10 mg, 14 mg, 20 mg, and 30 mg of the compound; (ii) about 10 ppm to about 500 ppm of a compound of Formula (II): and (iii) a pharmaceutically acceptable excipient. 2. The oral dosage form of claim 1, about 150 ppm to about 400 ppm of the compound of Formula (II) is present in the oral dosage form. 3. The oral dosage form of claim 1, wherein no more than about 50 ppm of the compound of Formula (II) is present in the oral dosage form. 4. The oral dosage form of claim 1, wherein no more than about 150 ppm of the compound of Formula (II) is present in the oral dosage form. 5. The oral dosage form of claim 1, wherein no more than about 300 ppm of the compound of Formula (II) is present in the oral dosage form. 6. The oral dosage form of claim 1, wherein no more than about 330 ppm of the compound of Formula (II) is present in the oral dosage form. 7. The oral dosage form of claim 1, wherein no more than about 700 ppm of the compound of Formula (II) is present in the oral dosage form. 8. The oral dosage form of claim 1, wherein the dihydrate form is present in the pharmaceutical composition in an amount to provide 14 mg of the compound. 9. The oral dosage form of claim 1, wherein the dihydrate form is present in the pharmaceutical composition in an amount to provide 20 mg of the compound. 10. The oral dosage form of claim 1, wherein the dihydrate form is present in the pharmaceutical composition in an amount to provide 30 mg of the compound. 11. The oral dosage form of claim 1, wherein the oral dosage form is a capsule. 12. A pharmaceutical composition, comprising: (i) a compound of Formula (I): or a hydrate thereof, wherein the compound or hydrate thereof is present in the pharmaceutical composition in an amount to provide a dose selected from the group consisting of 2 mg, 10 mg, 14 mg, 20 mg, and 30 mg of the compound; and (ii) a compound of Formula (II): wherein the compound of Formula (II) is present in the pharmaceutical composition, in an amount less than about 800 ppm; and (iii) a pharmaceutically acceptable excipient. 13. The pharmaceutical composition of claim 12, wherein less than about 50 ppm of the compound of Formula (II) is present in the pharmaceutical composition. 14. The pharmaceutical composition of claim 12, wherein less than about 150 ppm of the compound of Formula (II) is present in the pharmaceutical composition. 15. The pharmaceutical composition of claim 12, wherein less than about 300 ppm of the compound of Formula (II) is present in the pharmaceutical composition. 16. The pharmaceutical composition of claim 12, wherein less than about 330 ppm of the compound of Formula (II) is present in the pharmaceutical composition. 17. The pharmaceutical composition of claim 12, wherein less than about 500 ppm of the compound of Formula (II) is present in the pharmaceutical composition. 18. The pharmaceutical composition of claim 12, wherein less than about 700 ppm of the compound of Formula (II) is present in the pharmaceutical composition. 19. The pharmaceutical composition of claim 12, comprising a dihydrate form of the compound in an amount to provide 14 mg of the compound. 20. The pharmaceutical composition of claim 12, comprising a dihydrate form of the compound in an amount to provide 20 mg of the compound. 21. The pharmaceutical composition of claim 12, comprising a dihydrate form of the compound in an amount to provide 30 mg of the compound.

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