摘要
目的为经皮给药系统(TDDS)药物后续研究的开展提供参考。方法检索incoPat数据库2011年至2021年TDDS药物专利相关信息,分析专利申请及公开、专利持有人国别分布、专利持有人全球分布、我国专利持有人分布情况;检索国家药品监督管理局数据库,分析我国TDDS药物上市情况;检索美国食品和药物管理局数据库,分析相关药物美国上市情况;检索ClinicalTrials数据库2011年至2021年相关药物中美两国临床试验开展情况,分析相关药物上市/临床试验开展状况。结果2011年至2021年,共有TDDS药物相关专利4386件,其中我国居首(878件,20.02%,未统计中国澳门特别行政区数据),美国次之(599件,13.66%);全球TDDS药物相关专利持有人排名前10中有企业6家、高等院校2所、个人(持有者)2名,我国仅有中国药科大学入围;我国TDDS药物相关专利持有人排名前10中包括高等院校/科研院所8家及企业2家。我国已上市的TDDS药物共5种,其中国产药物2种(涉及5家企业)、进口药物3种;处于临床试验阶段的共8种,其中7种处于临床试验Ⅰ期、1种处于临床试验Ⅲ期。美国已上市的TDDS药物共21种,涉及生产企业69家;2种处于正在试验新的适应证阶段;2种处于临床试验Ⅱ期,1种处于临床试验Ⅲ期。结论TDDS有广阔的应用潜力,我国在该领域专利数量虽为全球最多,但当前仍转化乏力,药品生产企业应深化与医疗机构/高校院所的合作,提高专利技术转化成效。
Objective To provide a reference for the follow-up research of transdermal drug delivery system(TDDS)drugs.Methods Information related to TDDS drug patent in the incoPat database from 2011 to 2021 was searched to analyze the patent application and disclosure,country distribution of patentees,distribution in the world and China.The related information in the National Medical Products Administration was searched to analyze the marketing of TDDS drugs in China,and the related information in the Food and Drug Administration was searched to analyze the marketing of related drugs in the United States of America(USA).The clinical trials of related drugs in China and the USA in the ClinicalTrials database from 2011 to 2021 were searched to analyze the marketing and clinical trial development of related drugs.Results From 2011 to 2021,there were 4386 patents related to TDDS drugs.China had the most related patents(878 patents,20.02%),with no data from the Macao Special Administrative Region,China followed by the USA(599 patents,13.66%).Among the top 10 patentees holding more TDDS drug-related patents in the world,there were six enterprises,two universities and two individuals,and only China Pharmaceutical University in our country was shortlisted.Among the top 10 patentees holding more TDDS drug-related patents in China,there were eight universities/research institutes and two enterprises.There were five TDDS drugs marketed in China,including two domestic drugs(involving five enterprises)and three imported drugs.There were eight TDDS drugs in the clinical trial stage in China,of which seven were in the phaseⅠand one was in the phaseⅢ.There were a total of 21 TDDS drugs marketed in the USA,involving 69 enterprises.Among the above TDDS drugs,two were in the stage of new indication research,two were in the phaseⅡclinical trial,and one was in the phaseⅢ.Conclusion TDDS has broad potential for clinical application.Although China has the most related patents in the world,the current transformation is weak.Pharmaceutical
作者
杜海涛
李新辰
赵志刚
DU Haitao;LI Xinchen;ZHAO Zhigang(Beijing Tiantan Hospital,Capital Medical University,Beijing,China 100070)
出处
《中国药业》
CAS
2023年第14期22-26,共5页
China Pharmaceuticals
基金
中国药品监督管理研究会研究课题。
