Claims for Patent: 9,701,636

Summary for Patent: 9,701,636

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:	US14/541,284
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,701,636
Patent Claims:	1. A pharmaceutical composition comprising a crystalline Compound (I): wherein the crystalline Compound (I) has an X-ray powder diffraction pattern comprising peaks at approximately 15.0, 18.1, 20.3, 22.9, 24.0, 24.2, 26.3, 26.8, 35.2, and 37.4° 2θ and a melting point at 175.8° C.±5%; and wherein the pharmaceutical composition comprises less than 10% by weight of any other crystalline Compound (I). 2. The pharmaceutical composition of claim 1, wherein the crystalline compound comprises less than 5% by weight of any other crystalline Compound (I). 3. A pharmaceutical composition comprising a crystalline Compound (I): wherein the crystalline Compound (I) has an X-ray powder diffraction comprising peaks at approximately 15.0, 18.1, 20.3, 22.9, 24.0, 24.2, 26.3, 26.8, 35.2, and 37.4° 2θ and a melting point at 175.8° C.±5%; and wherein the pharmaceutical composition comprises less than 10% by weight of amorphous Compound (I). 4. The pharmaceutical composition of claim 3, wherein the crystalline compound comprises less than 5% by weight of amorphous Compound (I). 5. A crystalline Compound (I): which has an X-ray powder diffraction pattern comprising peaks at approximately 15.0, 18.1, 20.3, 22.9, 24.0, 24.2, 26.3, 26.8, 35.2, and 37.4° 2θ and a melting point at 175.8° C.±5%; and wherein the crystalline Compound (I) is at least 99.5% pure as measured by HPLC. 6. The crystalline compound of claim 5, wherein the crystalline Compound (I) is at least 99.6% pure as measured by HPLC. 7. The crystalline compound of claim 6, wherein the crystalline Compound (I) is at least 99.7% pure as measured by HPLC. 8. The crystalline compound of claim 7, wherein the crystalline Compound (I) is at least 99.8% pure as measured by HPLC. 9. The crystalline compound of claim 8, wherein the crystalline Compound (I) is at least 99.9% pure as measured by HPLC. 10. The pharmaceutical composition of claim 1, further comprising a pharmaceutically acceptable carrier. 11. An oral dosage form comprising a pharmaceutical composition of claim 1.