MUMBAI, India, June 26 -- Intellectual Property India has published a patent application (202641072512 A) filed by Dr. Naveen Mulakayala; Katam Reddy Vinod Kumar Reddy; Mrs. Yamini Tanuja; Mrs. Manjeera Amavasya; Ravi Shekar Reddy Nadipati; Nandyala Malyadri Reddy; and Dr. Krs Prasad on June 11, 2026, for A Process Of Preparation Of Lenvatinib Dimer And Dicarbonyl Impurities Of Kinase Inhibitor Against Vegfr1, Vegfr2, And Vegfr3 Kinases.
Inventors include Dr. Naveen Mulakayala; Katam Reddy Vinod Kumar Reddy; Mrs. Yamini Tanuja; Mrs. Manjeera Amavasya; Ravi Shekar Reddy Nadipati; Nandyala Malyadri Reddy; and Dr. Krs Prasad.
The application for the patent was published on June 19, 2026, under issue no. 25/2026.
Abstract: The present invention relates to the field of pharmaceutical chemistry and impurity profiling of active pharmaceutical ingredients, and more particularly to a process for the preparation of lenvatinib dimer and related impurities useful as analytical reference standards. Lenvatinib is a multi-targeted kinase inhibitor employed in the treatment of various cancers through inhibition of vascular endothelial growth factor receptors VEGFR1, VEGFR2, and VEGFR3. During the synthesis, processing, and storage of lenvatinib, structurally related impurities may be generated that require identification, characterization, and monitoring to ensure product quality and regulatory compliance. The invention provides an efficient and reproducible process for preparing N,N'-(propane-1,1-diyl)bis(4-(3-chloro-4-(3- cyclopropylureido)phenoxy)-7 methoxyquinoline-6-carboxamide), commonly referred to as the lenvatinib dimer impurity. The process comprises dissolving 4-(3- chloro-4-(3-cyclopropylureido) phenoxy)-7-methoxyquinoline-6-carboxamide in dimethyl sulfoxide, followed by reaction with propanaldehyde in the presence of sulfuric acid under controlled temperature conditions. The resulting product is isolated through solvent extraction and purified using chromatographic techniques to obtain the impurity in high purity and yield. The synthesized impurity is characterized using analytical methods including Mass Spectrometry, Nuclear Magnetic Resonance spectroscopy, and High-Performance Liquid Chromatography. The prepared impurity serves as a reliable analytical reference standard for impurity profiling, method validation, stability studies, quality control testing, and regulatory compliance of lenvatinib active pharmaceutical ingredients and pharmaceutical formulations. The invention improves impurity monitoring and supports the production of safe, effective, and high-quality lenvatinib-based pharmaceutical products.
Disclaimer: Curated by HT Syndication.
