WO2025210469 - PROCESS OF PREPARING REMIBRUTINIB SUBSTANTIALLY FREE OF NITROSAMINE IMPURITY

National phase entry:
Publication Number WO/2025/210469
Publication Date 09.10.2025
International Application No. PCT/IB2025/053341
International Filing Date 31.03.2025
Title **
[English] PROCESS OF PREPARING REMIBRUTINIB SUBSTANTIALLY FREE OF NITROSAMINE IMPURITY
[French] PROCÉDÉ DE PRÉPARATION DE REMIBRUTINIB SENSIBLEMENT EXEMPT D'IMPURETÉ DE NITROSAMINE
Applicants **
NOVARTIS AG
Inventors
CAILLET, Alexandre
CESAR, Jožko
KLANG, Thorsten
KORDIKOWSKI, Andreas
LOGAR, Maša
MALLET, Franck
PUPOWICZ, Doris Walli
ROBIČ, Peter
SLAKAN, Ana
Priority Data
63/573,025   02.04.2024   US
63/727,883   04.12.2024   US
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Quotation for National Phase entry

Country StagesTotal
China Filing, Examination, Granting4655
EPO Filing, Examination, Granting57657
Japan Filing, Examination, Granting3944
South Korea Filing, Examination, Granting5604
USA Filing, Examination, Granting25040
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Total: 96,900
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Abstract[English] -(3-(6-amino-5-(2(methyl)(nitroso)amino)ethoxy)pyrimidin-4-yl)-5-fluoro-2- methylphenyl)-4-cyclopropyl-2-fluorobenzamide. Pharmaceutical products containing said drug substance and compositions are also disclosed, as well as methods for preparing said drug substance, pharmaceutical compositions and products. Formula (I)[French] -(3-(6-amino-5-(2(méthyl)(nitroso)amino)éthoxy)pyrimidin-4-yl)-5-fluoro-2-méthylphényl)-4-cyclopropyl-2-fluorobenzamide. L'invention concerne également des produits pharmaceutiques contenant ladite substance médicamenteuse et des compositions, ainsi que des procédés de préparation de ladite substance médicamenteuse, des compositions pharmaceutiques et des produits.

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