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
Application details
| Total Number of Claims/PCT | * |
| Number of Independent Claims | * |
| Number of Priorities | * |
| Number of Multi-Dependent Claims | * |
| Number of Drawings | * |
| Pages for Publication | * |
| Number of Pages with Drawings | * |
| Pages of Specification | * |
| * | |
| Number of Office Actions | * |
| * | |
International Searching Authority |
EPO
* |
| Recordal of a Change of the Applicant's Name/Address |
Change of Applicant's Name and Address
* |
| Type of Assignment |
The Standard Agent's Assignment
* |
| Applicant's Legal Status |
Legal Entity
* |
| * | |
| * | |
| * | |
| * | |
| * | |
| Entry into National Phase under |
Chapter I
* |
| Patent Delivery |
Send the Letters Patent by Courier
* |
| Translation |
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* The data is based on automatic recognition. Please verify and amend if necessary.
** IP-Coster compiles data from publicly available sources. If this data includes your personal information, you can contact us to request its removal.
Quotation for National Phase entry
| Country | Stages | Total | |
|---|---|---|---|
| China | Filing, Examination, Granting | 4655 | |
| EPO | Filing, Examination, Granting | 57657 | |
| Japan | Filing, Examination, Granting | 3944 | |
| South Korea | Filing, Examination, Granting | 5604 | |
| USA | Filing, Examination, Granting | 25040 |

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.