IP Library Granted Patent US 11,370,739
Granted Patent B2
US 11,370,739 · App. 16/679,154 · Granted Jun 28, 2022

Sacubitril intermediate and preparation method thereof

Inventors: Lei Chen (Dongguan, CN); Guodong Sun (Dongguan, CN); Xiaodong Han (Dongguan, CN); Shun Li (Dongguan, CN); Jiebin Zeng (Dongguan, CN); Zhongqing Wang (Dongguan, CN); Zhonghua Luo (Dongguan, CN)
Assignee: Sunshine Lake Pharma Co., Ltd.
C07C59/205C07C45/65C07C49/245C07C49/255C07C49/35C07C51/09C07C59/84C07C67/317C07C69/716C07C69/738C07C231/02C07C231/12C07C233/11C07C233/47C07C235/78C07D498/04C07F7/1892C12P13/00
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Quick Facts
Patent No.
US 11,370,739
App. No.
16/679,154
Granted
Jun 28, 2022
Kind
B2
Abstract

The present invention relates to a sacubitril intermediate and a preparation method thereof. The sacubitril intermediate disclosed herein can be prepared by a deprotection reaction of a compound. In addition, the intermediate can be used as a raw material to synthesize sacubitril.

Claims (46)

1. A compound of Formula (V),

wherein:

R 1 is phenyl, methoxy, hydroxy, chloro, bromo, iodo, mesylate, triflate or 4-methylbenzenesulfonate;

R2 is

with the proviso that when R 1 is phenyl, R2 is not

R 3 is H, —(C 1 -C 4 )alkyl or —(C 1 -C 4 )alkyl-aryl; and

R 4 is H, —(C 1 -C 4 )alkyl, —(C 3 -C 6 )heterocyclyl, —(C 1 -C 4 )alkyl-aryl, trimethylsilyl, triethylsilyl or t-butyldimethylsilyl.

2. The compound of claim 1 , wherein R 1 is phenyl.

3. The compound of claim 1 , wherein R 3 is H, methyl, ethyl, n-propyl, i-propyl, n-butyl, t-butyl, benzyl or substituted benzyl.

4. The compound of claim 1 , wherein R 4 is H, methyl, ethyl, n-propyl, i-propyl, n-butyl, t-butyl, trimethylsilyl, triethylsilyl, t-butyldimethylsilyl, triphenylmethyl, tetrahydrofuryl, benzyl or substituted benzyl.

5. The compound of claim 1 , wherein R 2 is —COOH, —COOCH 3 , —COOCH 2 CH 3 , —COOCH(CH 3 ) 2 , —COOC(CH 3 ) 3 , —COOCH 2 Ph, —CH 2 OH, —CH 2 OCH 3 , —CH 2 OCH 2 CH 3 , —CH 2 OCH(CH 3 ) 2 , —CH 2 OC(CH 3 ) 3 , —CH 2 OCH 2 Ph, —CH 2 OC(Ph) 3 , —CH 2 OSi(CH 3 ) 3 , —CH 2 OSi(CH 2 CH 3 ) 3 , —CH 2 OSi(CH 3 ) 2 C(CH 3 ) 3 , —CONH 2 , —CONHCH 3 , —CONHCH 2 CH 3 , —CONHCH (CH 3 ) 2 , —CONHC (CH 3 ) 3 , —CONHCH 2 Ph or

with the proviso that when R 1 is phenyl, R 2 is —CH 2 OH, —CH 2 OCH 3 , —CH 2 OCH 2 CH 3 , —CH 2 OCH(CH 3 ) 2 , —CH 2 OC(CH 3 ) 3 , —CH 2 OCH 2 Ph, —CH 2 OC(Ph) 3 , —CH 2 OSi(CH 3 ) 3 , —CH 2 OSi(CH 2 CH 3 ) 3 , —CH 2 OSi(CH 3 ) 2 C(CH 3 ) 3 , —CONH 2 , —CONHCH 3 , —CONHCH 2 CH 3 , —CONHCH (CH 3 ) 2 , —CONHC (CH 3 ) 3 , —CONHCH 2 Ph or

and

wherein each Ph is phenyl.

6. The compound of claim 1 having one of the following structures:

where each Ph is phenyl.

7. The compound of claim 1 , wherein R 2 is

8. The compound of claim 7 , wherein R 1 is phenyl.

9. The compound of claim 7 , wherein R 4 is H.

10. The compound of claim 9 , wherein R 1 is phenyl.

11. A method of preparing a compound of Formula (V):

wherein the compound of Formula (V) is prepared by a deprotection reaction of a compound of Formula (IV):

in the presence of a base or an acid, wherein:

R 1 is phenyl, methoxy, hydroxy, chloro, bromo, iodo, mesylate, triflate or 4-methylbenzenesulfonate;

R 2 is

with the proviso that when R 1 is phenyl, R 2 is not

R 3 is H, —(C 1 -C 4 )alkyl or —(C 1 -C 4 )alkyl-aryl;

R 4 is H, —(C 1 -C 4 )alkyl, —(C 3 -C 6 )heterocyclyl, —(C 1 -C 4 )alkyl-aryl, trimethylsilyl, triethylsilyl or t-butyldimethylsilyl; and

R 5 is H, —(C 1 -C 4 )alkyl or —(C 1 -C 4 )alkyl-aryl.

12. The method of claim 11 , the compound of Formula (IV) is prepared by a substitution reaction of a compound of Formula (II) with a compound of Formula (III) in the presence of a base;

13. The method of claim 12 , the compound of Formula (II) is prepared by a condensation reaction of a compound of Formula (I);

wherein R 1 is as defined above; and

R 5 is H, —(C 1 -C 4 )alkyl or —(C 1 -C 4 )alkyl-aryl.

14. The method according to claim 11 , wherein the compound of the Formula (IV) is prepared by a process comprising the following steps:

a) preparing a compound of Formula (II) by a condensation reaction of a compound of Formula (I) in the presence of a base,

and

b) preparing a compound of Formula (IV) by a substitution reaction of the compound of Formula (II) with a compound of Formula (III) in the presence of a strong base;

wherein R 1 is phenyl;

R 2 is

R 3 is H, methyl, ethyl, n-propyl, i-propyl, n-butyl, t-butyl or benzyl;

R 4 is H, methyl, ethyl, n-propyl, i-propyl, n-butyl, t-butyl, benzyl, trimethylsilyl, triethylsilyl, t-butyldimethylsilyl, triphenylmethyl, or tetrahydrofuryl;

R 5 is H, methyl, ethyl, n-propyl, i-propyl, n-butyl or benzyl; and

R 6 is triflate, mesylate or 4-methylbenzenesulfonate.

15. The method of claim 14 wherein the compound of Formula (II) is prepared by a condensation reaction of the compound of Formula (I) with N,N′-carbonyldiimidazole and a compound of Formula (VIII):

in the presence of magnesium chloride and triethylamine, wherein R 5 is H, —(C 1 -C 4 )alkyl or —(C 1 -C 4 )alkyl-aryl.

16. The method of claim 14 , wherein the compound of Formula (II) is prepared by a condensation reaction of the compound of Formula (I) with Meldrum's acid, 4-dimethylaminopyridine, R 5 OH and pivaloyl chloride in the presence of N,N-diisopropylethylamine, R 5 is H, —(C 1 -C 4 )alkyl or —(C 1 -C 4 )alkyl-aryl.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 9, 2020
From: NORTH & SOUTH BROTHER PHARMACY INVESTMENT COMPANY LIMITED
To: SUNSHINE LAKE PHARMA CO., LTD.
Reel/Frame 052871/0397 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 9, 2019
From: SUNSHINE LAKE PHARMA CO., LTD.
To: NORTH & SOUTH BROTHER PHARMACY INVESTMENT COMPANY LIMITED
Reel/Frame 050963/0270 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 9, 2019
From: CHEN, LEI; SUN, GUODONG; HAN, XIAODONG; LI, SHUN; ZENG, JIEBIN; WANG, ZHONGQING; LUO, ZHONGHUA
To: SUNSHINE LAKE PHARMA CO., LTD.
Reel/Frame 050977/0479 →
Priority Claims (1)
CN 201610111396.6 · Feb 29, 2016 · national
Continuity (3)
Division 16112761 · Aug 26, 2018
Continuation In Part PCTCN2017075097 · Feb 28, 2017
Related Publication 20200079721A1 · Mar 12, 2020