Patent No. EP3782612 (titled "Oral Formulations Of Cytidine Analogs And Methods Of Use Thereof") was filed by Celgene on May 14, 2009. The application was issued on Nov 8, 2023.
Oral formulations of 5-azacytidine that release the drug substantially in the stomach and achieve high peak plasma concentrations, enabling effective treatment of hematological malignancies. These formulations achieve peak concentrations of at least 100 ng/mL and maintain therapeutic efficacy over 90 minutes, with a maximum plasma concentration of at least 200 ng/mL. The formulations are designed to release the drug in the stomach environment, where 5-azacytidine is primarily metabolized, and achieve this therapeutic window without enteric coating.

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| Company | Opposition Date | Representative |
|---|---|---|
| GENERICS UK | Aug 8, 2024 | ELKINGTON AND FIFE |
| HOFFMANN EITLE | Aug 8, 2024 | - |
| STADA ARZNEIMITTEL | Aug 8, 2024 | KERNEBECK |
| TEVA PHARMACEUTICALS | Aug 8, 2024 | D YOUNG |
| HAMM & WITTKOPP | Jul 30, 2024 | - |
The dossier documents provide a comprehensive record of the patent's prosecution history - including filings, correspondence, and decisions made by patent offices - and are crucial for understanding the patent's legal journey and any challenges it may have faced during examination.
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