Eagle Pharmaceuticals has patented a stable bendamustine-containing composition for long-term storage. The sterile vial contains bendamustine, a pharmaceutically acceptable fluid, and an antioxidant, with impurities less than 5% after 15 months of storage at 5-25°C. GlobalData’s report on Eagle Pharmaceuticals gives a 360-degree view of the company including its patenting strategy. Buy the report here.
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According to GlobalData’s company profile on Eagle Pharmaceuticals, Nanoparticle drug conjugates was a key innovation area identified from patents. Eagle Pharmaceuticals's grant share as of January 2024 was 43%. Grant share is based on the ratio of number of grants to total number of patents.
A recently granted patent (Publication Number: US11872214B2) discloses a sterile vial containing a liquid bendamustine-containing composition. The vial includes approximately 100 mg of bendamustine, with a concentration of about 25 mg/mL, along with a pharmaceutically acceptable fluid comprising polyethylene glycol and optional additives like propylene glycol, ethanol, benzyl alcohol, and glycofurol. An antioxidant, specifically monothioglycerol, is added in a stabilizing amount to ensure that the total impurities resulting from bendamustine degradation are less than 5% peak area response after at least 15 months at temperatures ranging from 5°C to 25°C. This composition demonstrates stability over an extended period, making it suitable for pharmaceutical use.
Furthermore, the patent also covers a liquid bendamustine-containing composition comprising 100 mg of bendamustine, or its salt, with an antioxidant in a pharmaceutically acceptable fluid. The fluid consists of polyethylene glycol and optional additives like propylene glycol, ethanol, benzyl alcohol, and glycofurol, with a bendamustine concentration of about 25 mg/mL. Similar to the previous claim, the composition must exhibit total impurities of less than 5% peak area response after at least 15 months at temperatures between 5°C to 25°C. The inclusion of monothioglycerol as the antioxidant ensures the stability of the composition, with an optional addition of ethanol for further enhancement. This patent highlights the importance of maintaining the integrity and efficacy of bendamustine-containing pharmaceutical formulations for an extended period, catering to the needs of patients and healthcare providers.
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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
