WO2025046547 - A STABLE SOLID ORAL DOSAGE FORM OF DABIGATRAN
National phase entry is expected:
Publication Number
WO/2025/046547
Publication Date
06.03.2025
International Application No.
PCT/IB2024/058498
International Filing Date
01.09.2024
Title **
[English]
A STABLE SOLID ORAL DOSAGE FORM OF DABIGATRAN
[French]
FORME POSOLOGIQUE ORALE SOLIDE STABLE DE DABIGATRAN
Applicants **
GLENMARK PHARMACEUTICALS LIMITED
Inventors
DHUPPAD, Ulhas
PAI, Raveendra
ASATI, Amit
WAGH, Sanjay
NAIK, Jyoti
PADSALGI, Amol
MAHAPURKAR, Anup
BHOSALE, Dileep
PATHAK, Shitalkumar
NAYAK, Tanmay
Priority Data
202321058899
01.09.2023
IN
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 |
IP India
* |
| 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 | 2099 | |
| EPO | Filing, Examination, Granting | 11600 | |
| Japan | Filing, Examination, Granting | 2181 | |
| South Korea | Filing, Examination, Granting | 2107 | |
| USA | Filing, Examination, Granting | 4740 |
Total:
22,727
The term for entry into the National Phase has expired. This quotation is for informational purposes only
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Abstract[English]
Described herein are stable solid oral capsule dosage form comprising dabigatran etexilate or pharmaceutically acceptable salt and at least one pharmaceutically acceptable excipient, wherein said dosage form has controlled and reduced levels of N-nitroso dabigatran (NDAB). Also, disclosed are methods of manufacturing such stable solid capsule oral dosage forms of dabigatran etexilate and its pharmaceutically acceptable salt.[French]
L'invention concerne une forme posologique de capsule orale solide stable comprenant de l'étéxilate de dabigatran ou un sel pharmaceutiquement acceptable et au moins un excipient pharmaceutiquement acceptable, ladite forme posologique ayant des niveaux contrôlés et réduits de N-nitroso dabigatran (NDAB). L'invention concerne également des procédés de fabrication de telles formes posologiques orales de capsules solides stables d'étéxilate de dabigatran et de son sel pharmaceutiquement acceptable.