IP Library Granted Patent US 11,690,836
Granted Patent B2
US 11,690,836 · App. 17/347,700 · Granted Jul 4, 2023

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

Inventors: James Densmore Copp (Silverthorne, CO); Ann W. Newman (Lafayette, IN); Anne Luong (Mississauga, CA)
Assignee: AKEBIA THERAPEUTICS, INC.
A61K31/444A61K9/14A61K9/2054A61K9/48A61K9/4866A61K31/4418C07D213/803C07D213/81C07B2200/13C07D221/00
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Quick Facts
Patent No.
US 11,690,836
App. No.
17/347,700
Granted
Jul 4, 2023
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 (27)

1. A crystalline Compound (I):

Which has an X-ray powder diffraction pattern comprising peaks at 8.6, 15.3, 22.7, and 28.1±0.2° 2θ.

2. The crystalline Compound (I) of claim 1 , which has an X-ray powder diffraction pattern as shown in FIG. 11 .

3. The crystalline Compound (I) of claim 1 , which has a DSC endotherm at about 176.2° C.

4. The crystalline Compound (I) of claim 1 , wherein the crystalline Compound (I) comprises less than 10% by weight of any other crystalline Compound (I).

5. The crystalline Compound (I) of claim 4 , wherein the crystalline Compound (I) comprises less than 5% by weight of any other crystalline Compound (I).

6. The crystalline Compound (I) of claim 1 , wherein the crystalline Compound (I) comprises less than 10% by weight of amorphous Compound (I).

7. The crystalline Compound (I) of claim 6 , wherein the crystalline Compound (I) comprises less than 5% by weight of amorphous Compound (I).

8. 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.

9. The crystalline Compound (I) of claim 8 , wherein the crystalline Compound (I) comprises less than 50 ppm of a compound of Formula (II) as determined by GC/MS.

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 a crystalline Compound (I) of claim 1 .

12. A method of treating anemia, comprising administering a pharmaceutical composition comprising an effective amount of a crystalline Compound (I) of claim 1 .

13. A crystalline Compound (I):

which has an X-ray powder diffraction pattern comprising peaks at 7.2, 17.4, 22.3, 22.4, 22.4, 28.9, 33.7, and 33.8±0.2° 2θ.

14. The crystalline Compound (I) of claim 13 , which has an X-ray powder diffraction pattern as shown in FIG. 12 .

15. The crystalline Compound (I) of claim 13 , wherein the crystalline Compound (I) comprises less than 10% by weight of any other crystalline Compound (I).

16. The crystalline Compound (I) of claim 15 , wherein the crystalline Compound (I) comprises less than 5% by weight of any other crystalline Compound (I).

17. The crystalline Compound (I) of claim 13 , wherein the crystalline Compound (I) comprises less than 10% by weight of amorphous Compound (I).

18. The crystalline Compound (I) of claim 17 , wherein the crystalline Compound (I) comprises less than 5% by weight of amorphous Compound (I).

19. The crystalline Compound (I) of claim 13 , wherein the crystalline Compound (I) comprises less than 100 ppm of a compound of Formula (II):

as determined by GC/MS.

20. The crystalline Compound (I) of claim 19 , wherein the crystalline Compound (I) comprises less than 50 ppm of a compound of Formula (II) as determined by GC/MS.

21. The crystalline Compound (I) of claim 13 , wherein the crystalline Compound (I) is at least 99.5% pure as measured by HPLC.

22. A pharmaceutical composition comprising a crystalline Compound (I) of claim 13 .

23. A method of treating anemia, comprising administering a pharmaceutical composition comprising an effective amount of a crystalline Compound (I) of claim 13 .

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 Mar 8, 2022
From: COPP, JAMES DENSMORE; NEWMAN, ANN W.; LUONG, ANNE
To: AKEBIA THERAPEUTICS, INC.
Reel/Frame 059192/0975 →
Continuity (7)
Continuation 16786187 · Feb 10, 2020
Continuation 16178191 · Nov 1, 2018
Continuation 15994348 · May 31, 2018
Division 15608186 · May 30, 2017
Division 14541284 · Nov 14, 2014
Provisional Application 61904803 · Nov 15, 2013
Related Publication 20220040159A1 · Feb 10, 2022
Cited By (1)
US 12,419,877