Claims for Patent: 11,065,237

Summary for Patent: 11,065,237

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:	US16/786,187
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,065,237
Patent Claims:	1. A crystalline Compound (I): which has an X-ray powder diffraction pattern comprising peaks at approximately 18.1, 20.3, 22.9, 24.0, and 26.3±0.2°2θ; wherein the crystalline Compound (I) is anhydrous and unsolvated; and comprises less than 10% by weight of any other amorphous or crystalline forms of Compound (I). 2. The crystalline Compound (I) of claim 1, comprising less than 5% by weight of any other amorphous or crystalline form of Compound (I). 3. The crystalline Compound (I) of claim 2, wherein the crystalline compound comprises less than 100 ppm of a compound of Formula (II), as determined by GC/MS. 4. The crystalline Compound (I) of claim 3, wherein the crystalline compound comprises less than 50 ppm of a compound of Formula (II). 5. The crystalline Compound (I) of claim 4, wherein the crystalline compound comprises less than 10 ppm of a compound of Formula (II). 6. The crystalline Compound (I) of claim 5, wherein the crystalline compound comprises less than 1 ppm of a compound of Formula (II). 7. The crystalline Compound (I) of claim 2, wherein the crystalline Compound (I) is at least 99.5% pure as measured by HPLC. 8. The crystalline Compound (I) of claim 7, wherein the crystalline Compound (I) is at least 99.6% pure as measured by HPLC. 9. The crystalline Compound (I) of claim 8, wherein the crystalline Compound (I) is at least 99.7% pure as measured by HPLC. 10. The crystalline Compound (I) of claim 9, wherein the crystalline Compound (I) is at least 99.8% pure as measured by HPLC. 11. The crystalline Compound (I) of claim 10, wherein the crystalline Compound (I) is at least 99.9% pure as measured by HPLC. 12. A pharmaceutical composition comprising a crystalline Compound (I) of claim 1. 13. A pharmaceutical composition of claim 12, further comprising a pharmaceutically acceptable carrier. 14. An oral dosage form comprising the crystalline Compound (I) of claim 1. 15. A method for treating anemia, comprising administering a crystalline Compound (I) of claim 1 to a patient having anemia. 16. A method for treating anemia, comprising administering a pharmaceutical composition of claim 13 to a patient having anemia. 17. The method of claim 15, wherein the anemia is anemia of chronic kidney disease. 18. The method of claim 16, wherein the anemia is anemia of chronic kidney disease.