Hikma Pharmaceuticals has been granted a patent for a ready-to-administer intravenous formulation of hydromorphone hydrochloride. The formulation, which includes sodium chloride and other components, is terminally sterilized and stable for at least six months under specified storage conditions. 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 June 2024 was 65%. 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 detail the formulation's ability to retain a high percentage of hydromorphone, with specific thresholds for degradation products after the storage period.
The patent also outlines methods for administering the formulation to patients experiencing moderate to severe pain due to various conditions, including surgery, cancer, and trauma. The liquid formulation can be packaged in an intravenous infusion bag, which may include ports for ease of use. The claims further specify that the formulation can be adjusted for pH and that terminal sterilization may be conducted via autoclave at temperatures ranging from 115°C to 130°C. Overall, the patent provides a comprehensive framework for a stable, sterile, and effective parenteral pain management solution.
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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
