IP Library Granted Patent US 9,701,636
Granted Patent B2
US 9,701,636 · App. 14/541,284 · Granted Jul 11, 2017

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 9,701,636
App. No.
14/541,284
Granted
Jul 11, 2017
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 (17)

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 .

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 19, 2015
From: COPP, JAMES DENSMORE; NEWMAN, ANN W.; LUONG, ANNE
To: AKEBIA THERAPEUTICS, INC.
Reel/Frame 035200/0106 →