Aurobindo Pharma has been granted a patent for a solid dispersion of Naloxegol oxalate and an improved process for its preparation. The process involves stereoselective reduction and purification steps, ultimately converting 3-O-MEM Naloxegol to Naloxegol or its salt. GlobalData’s report on Aurobindo 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 Aurobindo Pharma, Nanoparticle drug conjugates was a key innovation area identified from patents. Aurobindo Pharma's grant share as of June 2024 was 74%. Grant share is based on the ratio of number of grants to total number of patents.
Solid dispersion and improved process for naloxegol oxalate
The granted patent US11974996B2 outlines a detailed process for the preparation of Naloxegol or its salts, emphasizing a stereoselective reduction method. The process begins with the stereoselective reduction of 3-O-MEM naloxone using Lithium tri-tert-butoxy aluminium hydride (LTBA) as the reducing agent and 2-Methoxyethanol as an additive to yield 3-O-MEM a-Naloxol. The method includes optional purification steps involving an acid and a base, followed by the reaction of 3-O-MEM a-Naloxol with a side chain derived from either 22-bromo-heptaoxadocosane or 22-OMs-heptaoxadocosane to produce 3-O-MEM Naloxegol. The final step involves converting 3-O-MEM Naloxegol to Naloxegol or its salt through treatment with an acid.
Additionally, the patent describes a purification process for 3-O-MEM a-Naloxol, which includes treating the compound with an acid in a solvent to form an acid addition salt, specifically 3-O-MEM a-Naloxol oxalate, which is noted to be crystalline. The purification process aims to isolate the acid addition salt with less than 1% of the ß-epimer, followed by treatment with a base to regenerate 3-O-MEM a-Naloxol. The patent specifies that the purity of the final product should be approximately 99% or greater, with the acid being an organic acid and the base being an inorganic base.
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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
