WO2025158336 - REMIBRUTINIB DRUG SUBSTANCE AND DRUG PRODUCT SUBSTANTIALLY FREE OF NITROSAMINE IMPURITY
National phase entry:
Publication Number
WO/2025/158336
Publication Date
31.07.2025
International Application No.
PCT/IB2025/050760
International Filing Date
24.01.2025
Title **
[English]
REMIBRUTINIB DRUG SUBSTANCE AND DRUG PRODUCT SUBSTANTIALLY FREE OF NITROSAMINE IMPURITY
[French]
SUBSTANCE MÉDICAMENTEUSE DE RÉMIBRUTINIB ET PRODUIT MÉDICAMENTEUX SENSIBLEMENT EXEMPT D'IMPURETÉ DE NITROSAMINE
Applicants **
NOVARTIS AG
Inventors
CESAR, Jožko
FLEURY, Christian Roger Claude
KLANG, Thorsten
LOGAR, Maša
LOVELLE, Lucie
PUPOWICZ, Doris Walli
ROBIČ, Peter
SLAKAN, Ana
Priority Data
63/625,341
26.01.2024
US
63/727,876
04.12.2024
US
Application details
| Total Number of Claims/PCT | * |
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International Searching Authority |
EPO
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| Recordal of a Change of the Applicant's Name/Address |
Change of Applicant's Name and Address
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| Type of Assignment |
The Standard Agent's Assignment
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| Applicant's Legal Status |
Legal Entity
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| Entry into National Phase under |
Chapter I
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| Patent Delivery |
Send the Letters Patent by Courier
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| 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 | 3882 | |
| EPO | Filing, Examination, Granting | 34936 | |
| Japan | Filing, Examination, Granting | 3414 | |
| South Korea | Filing, Examination, Granting | 4581 | |
| USA | Filing, Examination, Granting | 19990 |
Total:
66,803
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Abstract[English]
This invention relates to N-(3-(6-Amino-5-(2-(N-methylacrylamido)ethoxy)pyrimidin-4-yl)-5-fluoro-2-methylphenyl)-4-cyclopropyl-2-fluorobenzamide drug substance substantially free of a nitrosamine impurity, e.g. the nitrosamine impurity N-(3-(6-amino-5-(2(methyl)(nitroso)amino)ethoxy)pyrimidin-4-yl)-5-fluoro-2-methylphenyl)-4-cyclopropyl-2-fluorobenzamide and novel processes of preparation thereof. The invention further relates to pharmaceutical composition comprising N-(3-(6-Amino-5-(2-(N- methylacrylamido)ethoxy)pyrimidin-4-yl)-5-fluoro-2-methylphenyl)-4-cyclopropyl-2-fluorobenzamide, wherein the composition is substantially free of a nitrosamine impurity, e.g. the nitrosamine impurity N-(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.[French]
La présente invention concerne une substance médicamenteuse de N-(3-(6-amino-5-(2-(N-méthylacrylamido)éthoxy)pyrimidin-4-yl)-5-fluoro-2-méthylphényl)-4-cyclopropyl-2-fluorobenzamide sensiblement exempte d'impureté de nitrosamine, par exemple l'impureté de nitrosamine N-(3-(6-amino-5-(2(méthyl)(nitroso)amino)éthoxy)pyrimidin-4-yl)-5-fluoro-2-méthylphényl)-4-cyclopropyl-2-fluorobenzamide, ainsi que de nouveaux procédés de préparation de celle-ci. L'invention concerne en outre une composition pharmaceutique comprenant N-(3-(6-amino-5-(2-(N-méthylacrylamido)éthoxy)pyrimidin-4-yl)-5-fluoro-2-méthylphényl)-4-cyclopropyl-2-fluorobenzamide, la composition étant sensiblement exempte d'impureté de nitrosamine, par exemple l'impureté de nitrosamine N-(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 lesdites substance médicamenteuse et compositions, ainsi que des procédés de préparation de ladite substance médicamenteuse, des compositions pharmaceutiques et des produits.