Hikma Pharmaceuticals has been granted a patent for a ready-to-administer intravenous formulation of hydromorphone. The formulation includes specific concentrations of hydromorphone hydrochloride, sodium chloride, sodium citrate dihydrate, and citric acid, and is designed for stability and terminal sterilization in a polymeric infusion container. GlobalData’s report on Hikma 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 Hikma Pharmaceuticals, was a key innovation area identified from patents. Hikma Pharmaceuticals's grant share as of July 2024 was 64%. Grant share is based on the ratio of number of grants to total number of patents.
Ready-to-administer hydromorphone intravenous liquid formulation
The granted patent US12011440B2 describes a ready-to-administer parenteral liquid formulation designed for pain management, specifically containing 0.2 mg/mL of hydromorphone hydrochloride, along with sodium chloride, sodium citrate dihydrate, and citric acid monohydrate. The formulation is characterized by a pH range of 3.5 to 4.2 and has been terminally sterilized in a polymeric infusion container, achieving an F0 value between 5 and 15. Notably, the formulation demonstrates stability for at least six months when stored at 25°C ± 2°C and relative humidity not exceeding 40%. Additional claims specify that the formulation can retain a high percentage of hydromorphone, with options for pH adjustment and autoclave sterilization.
The patent also encompasses the use of this liquid formulation in clinical settings, allowing for parenteral administration to patients experiencing moderate to severe pain due to various conditions, including surgery, cancer, and trauma. Furthermore, the formulation is packaged in intravenous infusion bags, which may include ports for ease of administration. The claims highlight the formulation's osmolality, stability, and sterilization methods, ensuring its suitability for medical use. Overall, this patent presents a comprehensive approach to delivering a stable and effective pain management solution in a sterile format.
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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
