MUMBAI, India, Sept. 22 -- Intellectual Property India has published a patent application (202521021725 A) filed by Embio Limited on March 11, 2025, for “process For Preparation Of Lisdexamphetamine”.
Inventors include Kotharkar Sandeep Anilrao; Dendukuri Venkata Padmanabha Kishore; Gole Pradeep Laxman; and Haldankar Siddhesh Suresh.
The application for the patent was published on September 18, 2026, under issue no. 38/2026.
Abstract: 5 Formula-I The present invention provides an efficient and improved process for the preparation of Lisdexamphetamine and its pharmaceutically acceptable salts. The process involves the conversion of l-norephedrine to (2S)-2-amino-1- phenylpropane via a chiral intermediate, (4S, 5R)-4-Methyl-5-Phenyl-2- 10 oxazolidinone, synthesized by treating l-norephedrine with dimethyl carbonate in the presence of alkali alkoxides, such as sodium methoxide. (2S)-2-amino-1- phenylpropane is then coupled with amine- and hydroxyl-protected L-Lysine, specifically Di-Boc-L-Lysine-p-nitrophenyl ester (Di-Boc-L-Lysine-ONP), to form Lisdexamphetamine. The process concludes with deprotection and conversion to 15 pharmaceutically acceptable salts. The invention offers advantages such as high yield, improved purity, and scalability, making it cost-effective and suitable for large-scale pharmaceutical manufacturing. Additionally, the use of specific protection groups, including Boc for amines and p-nitrophenol for hydroxyls, ensures efficient coupling and synthesis. The described process is ideal for 20 producing Lisdexamphetamine for therapeutic applications.
Disclaimer: Curated by HT Syndication.
