Claims for Patent: 9,987,262

Summary for Patent: 9,987,262

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:	US15/608,186
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,987,262
Patent Claims:	1. A method for treating anemia, comprising administering a therapeutically effective amount of a 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; to a patient having anemia. 2. A method for treating anemia, comprising administering a pharmaceutical composition comprising a therapeutically effective amount of a 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; to a patient having anemia. 3. The method of claim 1, wherein the anemia is anemia secondary to or associated with chronic kidney disease. 4. The method of claim 2, wherein the anemia is anemia secondary to or associated with chronic kidney disease. 5. The method of claim 1, wherein the crystalline compound comprises less than 5% by weight of any other crystalline form of Compound (I). 6. The method of claim 2, wherein the pharmaceutical composition comprises less than 5% by weight of any other crystalline form of Compound (I). 7. The method of claim 5, wherein the anemia is anemia secondary to or associated with chronic kidney disease. 8. The method of claim 6, wherein the anemia is anemia secondary to or associated with chronic kidney disease. 9. The method of claim 1, wherein the crystalline Compound (I) is at least 99.5% pure as measured by HPLC. 10. The method of claim 1, wherein the therapeutically effective amount of the crystalline Compound (I) comprises less than 100 ppm of a compound of Formula (II): as determined by GC/MS. 11. The method of claim 1, wherein the therapeutically effective amount of the crystalline Compound (I) comprises less than 5% by weight of any amorphous form of Compound (I). 12. The method of claim 2, wherein the crystalline Compound (I) is at least 99.5% pure as measured by HPLC. 13. The method of claim 2, wherein the pharmaceutical composition comprises less than 100 ppm of a compound of Formula (II): as determined by GC/MS. 14. The method of claim 2, wherein the pharmaceutical composition comprises less than 5% by weight of amorphous form of Compound (I). 15. A method for treating anemia, comprising administering a therapeutically effective amount of a crystalline Compound (I): which has an X-ray powder diffraction pattern as shown in FIG. 1, to a patient having anemia.