US 11,440,912 B2Granted

Process for the preparation of ribociclib and its salts

AssigneeFresenius Kabi Oncology Limited

InventorsSarbjot Singh Sokhi, Govind Singh, Saswata Lahiri, Maneesh Kumar Pandey, Raj Narayan Tiwari, Sonu Shukla, Sachin Musmade, Heena Dua, Walter Cabri

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Abstract

The invention relates to a process for the preparation of ribociclib of formula V or its salts. The invention provides novel crystalline forms of ribociclib succinate and ribociclib trifluoroacetate. The present invention also relates to pharmaceutical compositions comprising a crystalline form of ribociclib succinate and at least a pharmaceutically acceptable carrier. It further relates to the use of such compositions in the treatment of cancer.

Claims11

Dependent claims

A process for the preparation of a compound of formula V or a salt thereof,

comprising the steps of:
a) reacting a compound of formula B,
wherein X selected from bromo and chloro;
with a compound of formula C,
wherein PG is an amine protecting group;
in water in the presence of a base, which is sodium carbonate, potassium carbonate, diethylamine, N,N-diisopropylethylamine, or a combination thereof, to obtain a compound of formula A,
wherein PG is an amine protecting group;
b) converting the compound of formula A to the compound of formula V, and
c) optionally, converting the compound of formula V to a salt.

6 more elements

Dependencies are inferred from the claim text.

Facts

Application: 16/758,773Filed 26 Oct 2018
Priority: IN 20171103812827 Oct 2017
Published: US 2020/0277295 A13 Sep 2020
Granted: 13 Sep 2022
Term ends: Not estimatedThe source records don’t support an estimate.

Classification10 codes

C07D 487/04
In which the condensed system contains two hetero rings: ortho-condensed systems
A61P 35/00
Antineoplastic agents
B01J 23/72
Of the iron group metals or copper: copper
C07D 213/74
Nitrogen atoms: amino or imino radicals substituted by hydrocarbon or substituted hydrocarbon radicals

Family

US 2020/0277295 A1Pre-grant publication · published 3 Sep 2020
US 11,440,912 B2This patent

From the US filing history. Foreign family members aren’t listed.

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