IP Library Granted Patent US 10,149,842
Granted Patent B2
US 10,149,842 · App. 15/994,348 · Granted Dec 11, 2018

Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof

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Quick Facts
Patent No.
US 10,149,842
App. No.
15/994,348
Granted
Dec 11, 2018
Kind
B2
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.

Claims (24)

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 .

Assignments (2)
SECURITY INTEREST Recorded Jan 29, 2024
From: AKEBIA THERAPEUTICS, INC.; KERYX BIOPHARMACEUTICALS, INC.
To: KREOS CAPITAL VII (UK) LIMITED
Reel/Frame 066377/0654 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 23, 2018
From: COPP, JAMES DENSMORE; NEWMAN, ANN W.; LUONG, ANNE
To: AKEBIA THERAPEUTICS, INC.
Reel/Frame 046430/0883 →
Cited By (7)
US 12,269,802 US 12,419,877 US 12,478,615 US 12,569,474 US 12,612,367 US 12,629,357 US 12,673,919