Otsuka has been granted a patent for a solid oral dosage form containing specific ingredients that provide plasma levels of decitabine equivalent to intravenous administration. This innovation allows for effective treatment through oral medication, offering a convenient alternative to traditional IV methods. GlobalData’s report on Otsuka gives a 360-degree view of the company including its patenting strategy. Buy the report here.

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Data Insights Otsuka Holdings Co Ltd - Company Profile

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According to GlobalData’s company profile on Otsuka, was a key innovation area identified from patents. Otsuka's grant share as of April 2024 was 50%. Grant share is based on the ratio of number of grants to total number of patents.

Oral dosage form providing equivalent decitabine levels to iv infusion

Source: United States Patent and Trademark Office (USPTO). Credit: Otsuka Holdings Co Ltd

A recently granted patent (Publication Number: US11963971B2) discloses a solid oral dosage form designed for the administration of 100 mg cedazuridine and 35 mg decitabine to humans. The dosage form includes various excipients such as lactose monohydrate, hydroxypropyl methyl cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate, with the option of a coating. When taken daily, this dosage form is claimed to provide plasma levels of decitabine that result in a 5-day AUC equivalent to that of a daily intravenous dose of decitabine of 20 mg/m2 administered as a 1-hour infusion.

Furthermore, the patent claims that the solid oral dosage form can also deliver a pharmacodynamic effect comparable to that of the intravenous decitabine dose, specifically in terms of DNA demethylation. The dosage form can be in the form of a tablet or a capsule, with the possibility of including a coating, such as the specified Opadry II 85F15458 Red color coating. The ratio of AUC for decitabine on day 2 versus day 1 is also highlighted, falling within the range of about 1.5:1 to about 2:1 upon daily administration to humans. These claims emphasize the potential of this solid oral dosage form to provide an effective and convenient alternative to intravenous administration for the specified therapeutic purposes.

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData Patent Analytics tracks bibliographic data, legal events data, point in time patent ownerships, and backward and forward citations from global patenting offices. Textual analysis and official patent classifications are used to group patents into key thematic areas and link them to specific companies