Endo International has filed a patent for a storage-stable, sterile, ready-to-administer pharmaceutical composition containing isoproterenol, tartaric acid buffer, chelating agent, tonicity agent, and water. The formulation has a pH of 3.0-4.5, with minimal impurities after storage at high temperatures, suitable for intravenous administration without antioxidants. GlobalData’s report on Endo International 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 Endo International, was a key innovation area identified from patents. Endo International's grant share as of January 2024 was 64%. Grant share is based on the ratio of number of grants to total number of patents.

Isoproterenol pharmaceutical composition for intravenous administration with stability characteristics

Source: United States Patent and Trademark Office (USPTO). Credit: Endo International Plc

The patent application (Publication Number: US20240024260A1) describes a storage-stable sterile ready-to-administer pharmaceutical composition for intravenous administration. The composition includes isoproterenol at a concentration between 1 and 10 mcg/mL, a buffer with tartaric acid, a chelating agent, a tonicity agent, and water. The pH of the composition ranges from 3.0 to 4.5, with minimal impurities formed from isoproterenol degradation after storage at elevated temperatures. The formulation is free of antioxidants to ensure stability.

Furthermore, the patent application details a method for preparing the composition, involving sterilization through thermal processes. The composition can also include buffers like acetic acid or glutamic acid, along with ethylenediamine tetraacetic acid as the chelating agent. The tonicity agent, typically NaCl, is present in specific concentrations to achieve the desired tonicity level for intravenous administration. The composition is designed to maintain stability and sterility even after storage under challenging conditions, making it suitable for clinical use.

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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