IP Library › Granted Patent US 12,213,968
Granted Patent B2
US 12,213,968 · App. 18/795,731 · Granted Feb 4, 2025

Compositions of 1-(4-bromo-5-(1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl)-2-fluoropheyl)-3-phenylurea

Inventors: Michael D. Kaufman (Waltham, MA); Scott Bone (Bend, OR); Corey Bloom (Bend, OR); Fred Jordan (Bend, OR)
Assignee: Deciphera Pharmaceuticals, LLC
A61K31/4375A61K9/0053A61K9/10A61K47/38
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Quick Facts
Patent No.
US 12,213,968
App. No.
18/795,731
Granted
Feb 4, 2025
Kind
B2
Abstract

Provided herein are low impurity compositions comprising a compound represented by Formula (I): which are useful in the treatment of disorders related to the activity of the c-KIT and PDGFRα kinases, and oncogenic forms thereof.

Claims (32)

1. A pharmaceutical composition comprising:

a solid dispersion comprising: a compound represented by Formula (I) or pharmaceutically acceptable salt thereof,

and hydroxypropylmethyl cellulose acetate succinate; and

wherein a compound represented by Formula (II):

is present in an amount equal to or less than about 10% by weight based on the weight of the compound of Formula (I) present in the composition.

2. The pharmaceutical composition of claim 1 , wherein the compound represented by Formula (II) is present in an amount equal to or less than about 5% by weight based on the weight of the compound of Formula (I) present in the composition.

3. The pharmaceutical composition of claim 1 , wherein the compound represented by Formula (II) is present in an amount equal to or less than about 3% by weight based on the weight of the compound of Formula (I) present in the composition.

4. The pharmaceutical composition of claim 1 , wherein the compound represented by Formula (II) is present in an amount equal to or less than about 1% by weight based on the weight of the compound of Formula (I) present in the composition.

5. The pharmaceutical composition of claim 1 , wherein the compound represented by Formula (II) is present in an amount equal to or less than about 0.5% by weight based on the weight of the compound of Formula (I) present in the composition.

6. A pharmaceutical composition comprising:

a solid dispersion comprising: a compound represented by Formula (I) or pharmaceutically acceptable salt thereof,

and hydroxypropylmethyl cellulose acetate succinate; and

wherein a compound represented by Formula (III):

is present in an amount equal to or less than about 10% by weight based on the weight of the compound of Formula (I) present in the composition.

7. The pharmaceutical composition of claim 6 , wherein the compound represented by Formula (III) is present in an amount equal to or less than about 5% by weight based on the weight of the compound of Formula (I) present in the composition.

8. The pharmaceutical composition of claim 6 , wherein the compound represented by Formula (III) is present in an amount equal to or less than about 3% by weight based on the weight of the compound of Formula (I) present in the composition.

9. The pharmaceutical composition of claim 6 , wherein the compound represented by Formula (III) is present in an amount equal to or less than about 1% by weight based on the weight of the compound of Formula (I) present in the composition.

10. The pharmaceutical composition of claim 6 , wherein the compound represented by Formula (III) is present in an amount equal to or less than about 0.5% by weight based on the weight of the compound of Formula (I) present in the composition.

11. A pharmaceutical composition comprising:

a solid dispersion comprising: a compound represented by Formula (I) or pharmaceutically acceptable salt thereof,

and hydroxypropylmethyl cellulose acetate succinate; and

aniline in an amount equal to or less than about 10% by weight based on the weight of the compound of Formula (I) present in the composition.

12. The pharmaceutical composition of claim 11 , wherein aniline is present in an amount equal to or less than about 5% by weight based on the total weight of the weight of the compound of Formula (I) present in the composition.

13. The pharmaceutical composition of claim 11 , wherein aniline is present in an amount equal to or less than about 3% by weight based on the weight of the compound of Formula (I) present in the composition.

14. The pharmaceutical composition of claim 11 , wherein aniline is present in an amount equal to or less than about 1% by weight based on the weight of the compound of Formula (I) present in the composition.

15. The pharmaceutical composition of claim 11 , wherein aniline is present in an amount equal to or less than about 0.5% by weight based on the weight of the compound of Formula (I) present in the composition.

16. A pharmaceutical composition comprising:

a solid dispersion comprising: a compound represented by Formula (I) or pharmaceutically acceptable salt thereof,

and hydroxypropylmethyl cellulose acetate succinate; and

diphenyl urea in an amount equal to or less than about 3% by weight based on the weight of the compound of Formula (I) present in the composition.

17. The pharmaceutical composition of claim 16 , wherein diphenyl urea is present in an amount equal to or less than about 1% by weight based on the weight of the compound of Formula (I) present in the composition.

18. The pharmaceutical composition of claim 16 , wherein diphenyl urea is present in an amount equal to or less than about 0.5% by weight based on the weight of the compound of Formula (I) present in the composition.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 25, 2024
From: BONE, SCOTT; BLOOM, COREY; JORDAN, FRED
To: BEND RESEARCH, INC.
Reel/Frame 068693/0804 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 25, 2024
From: KAUFMAN, MICHAEL D.
To: DECIPHERA PHARMACEUTICALS, LLC
Reel/Frame 068693/0812 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 25, 2024
From: BEND RESEARCH, INC.
To: DECIPHERA PHARMACEUTICALS, LLC
Reel/Frame 068693/0846 →
Continuity (13)
Continuation 18758007 · Jun 28, 2024
Continuation 18518093 · Nov 22, 2023
Continuation 18448312 · Aug 11, 2023
Continuation 18178789 · Mar 6, 2023
Continuation 18148766 · Dec 30, 2022
Continuation 17735820 · May 3, 2022
Continuation 17180241 · Feb 19, 2021
Continuation PCTUS2020067560 · Dec 30, 2020
Provisional Application 62968695 · Jan 31, 2020
Provisional Application 62968724 · Jan 31, 2020
Provisional Application 62955062 · Dec 30, 2019
Provisional Application 62955073 · Dec 30, 2019
Related Publication 20240390345A1 · Nov 28, 2024
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