IP Library › Granted Patent US 10,800,787
Granted Patent B2
US 10,800,787 · App. 16/605,972 · Granted Oct 13, 2020

Process for the preparation of acalabrutinib

Inventors: Prabhudas Bodhuri (San Ramon, CA); Boris Gorin (Oakville, CA); Melanie R. A. Green (Milton, CA); Gamini Weeratunga (Ancaster, CA)
Assignee: Apotex Inc.
C07D487/04B01J31/2295
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Quick Facts
Patent No.
US 10,800,787
App. No.
16/605,972
Granted
Oct 13, 2020
Kind
B2
Abstract

The present invention provides processes for the preparation of Acalabrutinib (1), as well as intermediates useful in the preparation thereof. In particular, processes are provided for coupling of a compound of Formula (5) and 2-butynoic acid in the presence of Carbodiimide (8) to afford Acalabrutinib (1).

Claims (42)

1. A process for the preparation of Acalabrutinib (1):

comprising:

(i) treating a compound of Formula (7):

with a carbodiimide selected from the group consisting of:

optionally in the presence of Additive (A-H):

A-H,

wherein:

A is selected from the group consisting of:

wherein:

(a) R a is H; and

R b is H; or

(b) R a is R c ; and

R b is R d ;

R c and R d , taken together with the carbon atoms to which they are bonded, form a C 3-12 cycloaliphatic, C 6-10 aryl, or C 5-9 heteroaryl, wherein the C 3-12 cycloaliphatic, C 6-10 aryl, and C 5-9 heteroaryl are each optionally substituted with nitro, and further wherein the C 5-9 heteroaryl has at least one heteroatom selected from the group consisting of nitrogen, oxygen, and sulfur; and

R 3 is C 6-10 aryl, optionally substituted with nitro;

to provide an activated acid derivative selected from the group consisting of (a) and (b):

(a)

and

(b) a compound of Formula (4):

wherein:

A is selected from the group consisting of:

wherein:

(a) R a is H; and

 R b is H; or

(b) R a is R c ; and

 R b is R d ;

 R c and R d , taken together with the carbon atoms to which they are bonded, form a C 3-12 cycloaliphatic, C 6-10 aryl, or C 5-9 heteroaryl, wherein the C 3-12 cycloaliphatic, C 6-10 aryl, and C 5-9 heteroaryl are each optionally substituted with nitro, and further wherein the C 5-9 heteroaryl has at least one heteroatom selected from the group consisting of nitrogen, oxygen, and sulfur; and

R 3 is C 6-10 aryl, optionally substituted with nitro; and

(ii) coupling the activated acid derivative formed in step (i) above with a compound of Formula (5):

wherein:

G 1 is

2. The process of claim 1 , wherein the carbodiimide is selected from the group consisting of:

3. The process of claim 1 , wherein the compound of Formula (7) is treated with a carbodiimide in the presence of Additive (A-H) to provide the activated acid derivative.

4. The process of claim 3 , wherein:

R c and R d , taken together with the carbon atoms to which they are bonded, form a phenyl, optionally substituted with nitro; and

R 3 is phenyl, optionally substituted with nitro.

5. The process of claim 3 , wherein Additive (A-H) is selected from the group consisting of:

6. The process of claim 3 , wherein the activated acid derivative is a compound of Formula (4):

7. The process of claim 6 , wherein A is selected from the group consisting of:

8. The process of claim 6 , wherein the activated acid derivative is the compound of Formula (4-A):

9. The process of claim 6 , wherein the activated acid derivative is isolated prior to step (ii).

10. The process of claim 3 , wherein step (i) is completed prior to performing step (ii).

Assignments (2)
SECURITY INTEREST Recorded Apr 15, 2023
From: APOTEX INC.
To: THE BANK OF NOVA SCOTIA
Reel/Frame 063364/0710 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 17, 2019
From: BODHURI, PRABHUDAS; GORIN, BORIS; GREEN, MELANIE R. A.; WEERATUNGA, GAMINI
To: APOTEX INC.
Reel/Frame 050749/0089 →
Continuity (2)
Provisional Application 62487683 · Apr 20, 2017
Related Publication 20200048264A1 · Feb 13, 2020
Cited By (8)
US 12,202,845 US 12,252,497 US 12,280,113 US 12,384,750 US 12,403,196 US 12,409,225 US 12,448,387 US 12,465,643