Claims for Patent: 10,149,842

Summary for Patent: 10,149,842

Title:	Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof
Abstract:	Provided herein are solid forms comprising {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions comprising the solid forms, methods of making the solid forms and methods of their use for the treatment of various diseases and/or disorders.
Inventor(s):	James Densmore Copp, Ann W. Newman, Anne Luong
Assignee:	Akebia Therapeutics Inc
Application Number:	US15/994,348
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,149,842
Patent Claims:	1. Crystalline Compound (I): which has an X-ray powder diffraction pattern comprising peaks at 18.1, 20.3, 22.9, 24.0, and 26.3±0.2° 2θ. 2. The crystalline compound (I) of claim 1, wherein the crystalline compound comprises less than 10% by weight of any other crystalline Compound (I). 3. The crystalline compound (I) of claim 2, wherein the crystalline compound (I) comprises less than 5% by weight of any other crystalline Compound (I). 4. The crystalline compound (I) of claim 1, wherein the crystalline compound comprises less than 10% by weight of amorphous Compound (I). 5. The crystalline compound (I) of claim 4, wherein the crystalline compound (I) comprises less than 5% by weight of amorphous Compound (I). 6. The crystalline compound (I) of claim 1, which has a DSC endotherm at about 175.8° C. 7. The crystalline compound (I) of claim 1, wherein the crystalline compound (I) comprises less than 100 ppm of a compound of Formula (II), as determined by GC/MS. 8. The crystalline compound (I) of claim 7, wherein the crystalline compound (I) comprises less than 50 ppm of a compound of Formula (II). 9. The crystalline compound (I) of claim 8, wherein the crystalline compound (I) comprises less than 10 ppm of a compound of Formula (II). 10. The crystalline Compound (I) of claim 1, wherein the crystalline Compound (I) is at least 99.5% pure as measured by HPLC. 11. A pharmaceutical composition comprising the crystalline compound (I) of claim 1. 12. An oral dosage form comprising the crystalline compound (I) of claim 1. 13. Crystalline Compound (I), which has an X-ray powder diffraction pattern as shown in FIG. 1. 14. A pharmaceutical composition comprising the crystalline compound (I) of claim 13. 15. Crystalline Compound (I), prepared by crystallization from a solution comprising acetone and Compound (I). 16. The crystalline compound (I) of claim 15, which has an X-ray powder diffraction pattern comprising peaks at 18.1, 20.3, 22.9, 24.0, and 26.3±0.2° 2θ. 17. The crystalline compound (I) of claim 16, which has a DSC endotherm at about 175.8° C. 18. A pharmaceutical composition comprising the crystalline compound (I) of claim 15. 19. A pharmaceutical composition comprising the crystalline compound (I) of claim 7. 20. A pharmaceutical composition comprising the crystalline compound (I) of claim 10.