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. GlobalData’s report on Eagle Pharmaceuticals gives a 360-degree view of the company including its patenting strategy. Buy the report here.
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 February 2024 was 45%. 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 composition includes about 100 mg of bendamustine, a pharmaceutically acceptable salt, with a concentration of approximately 25 mg/mL. The formulation also comprises a pharmaceutically acceptable fluid, such as polyethylene glycol, and an antioxidant to ensure stability. The patent specifies that the total impurities resulting from bendamustine degradation should be less than 5% peak area response after at least 15 months at temperatures ranging from 5°C to 25°C.
Furthermore, the patent details the inclusion of monothioglycerol as the antioxidant in the composition, with a concentration of around 5 mg/mL. The formulation is designed to remain stable for a minimum of 15 months at either 5°C or 25°C. Additionally, the liquid bendamustine-containing composition may also contain ethanol, providing a comprehensive overview of the components and conditions necessary for maintaining the integrity and efficacy of the pharmaceutical product over an extended period.
To know more about GlobalData’s detailed insights on Eagle Pharmaceuticals, buy the report here.
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