Natco Pharma has been granted a patent for an improved process to prepare Sugammadex sodium with high purity levels. The process ensures more than 98.5% purity, less than 1.0% monohydroxy Sugammadex sodium, and less than 0.15% impurities by HPLC analysis. GlobalData’s report on Natco Pharma 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 Natco Pharma, Cancer treatment biomarkers was a key innovation area identified from patents. Natco Pharma's grant share as of January 2024 was 36%. Grant share is based on the ratio of number of grants to total number of patents.

High purity process for preparing sugammadex sodium formula

Source: United States Patent and Trademark Office (USPTO). Credit: Natco Pharma Ltd

A recently granted patent (Publication Number: US11845811B2) discloses an improved process for the preparation of Sugammadex sodium, a pharmaceutical compound used for reversing the effects of neuromuscular blocking agents during surgery. The process involves specific steps using various organic solvents such as toluene, cyclohexane, N,N-Dimethylformamide, and others to ensure the purity of the final product. The patent also details the specific mole equivalents of reagents required and identifies known impurities that need to be controlled during the manufacturing process.

Furthermore, the patent describes the creation of a unique crystalline form of Sugammadex sodium, designated as Form-N, with specific X-ray powder diffraction patterns. This crystalline form is obtained through a precise process involving the precipitation of Sugammadex sodium from an aqueous solution using ethanol, filtration, and drying at controlled temperatures. The patent also covers the inclusion of this crystalline Form-N in a pharmaceutical composition along with a pharmaceutically acceptable carrier, highlighting its potential application in the development of new medications 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