全球已上市的氘代药物及其专利分析

Globally approved deuterated drugs and patent research thereof

摘要

本文对全球已上市的7个氘代药物及其专利信息分别进行了梳理。首先简要介绍7个氘代药物的原研厂家及开发厂家、首次批准国家及上市时间、适应证、主要优势以及在中国进入《国家基本医疗保险、工伤保险和生育保险药品目录》的情况;其次,详细分析和解读了原研厂家、开发厂家和其他申请人针对这些创新药物在不同技术主题如化合物、药物制剂、药物组合物、药物新用途等方面的专利情况,包括中国上市药品专利信息登记平台公示情况、技术内容、全球布局等,重点介绍了不同技术主题在中国的专利申请基本信息及法律状态,并分析了中国上市氘代药物的化合物专利到期日、相关药物专利技术布局的薄弱环节,以期为我国医药企业在进行氘代药物产品立项与开发以及进行新的专利挖掘、专利保护与布局时,提供有效的专利信息参考。

Abstract

This article reviews the patent information of seven deuterated drugs approved globally. It first briefly introduces, for each of the seven deuterated drugs, the originator and developing companies, the country and date of first approval, indications, main advantages, and inclusion status in China's National Reimbursement Drug List (NRDL). It then provides a detailed analysis and interpretation of the patents filed by the originator companies, developing companies, and other applicants in various technical fields, such as compounds, pharmaceutical formulations, pharmaceutical compositions, and new therapeutic uses. The analysis covers the information published on the China Patent Information Registration Platform for Marketed Drugs, the technical content, and the global patent portfolio strategies, with a focus on the basic information and legal status of patent applications in China in different technical fields. The article also analyzes the expiration dates of compound patent for deuterated drugs approved in China and identifies vulnerabilities in the associated patent technology landscapes, so as to provide an effective patent information reference for Chinese pharmaceutical enterprises in project selection, new development initiatives, patent mining, patent protection, and patent portfolio construction involving deuterated drugs.

关键词

氘代药物 / 氘丁苯那嗪 / 甲苯磺酸多纳非尼 / 氢溴酸氘瑞米德韦 / 氘可来昔替尼 / 磷酸氘芦可替尼 / 氘恩扎鲁胺 / 吉卡昔替尼 / 专利分析

Key words

deuterated drugs / deutetrabenazine / donafenib tosilate / deuremidevir hydrobromide / deucravacitinib / deuruxolitinib phosphate / deutenzalutamide / gecacitinib / patent analysis

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