美国食品和药物管理局提供的竞争性仿制药治疗和专利挑战排他性下仿制药开发和批准程序失败的风险评估

Q4 Pharmacology, Toxicology and Pharmaceutics
M. V. Reddy, Gnk Ganesh, B. Babu, Ramesh Jagadeesan, P. Mr
{"title":"美国食品和药物管理局提供的竞争性仿制药治疗和专利挑战排他性下仿制药开发和批准程序失败的风险评估","authors":"M. V. Reddy, Gnk Ganesh, B. Babu, Ramesh Jagadeesan, P. Mr","doi":"10.2478/amma-2022-0004","DOIUrl":null,"url":null,"abstract":"Abstract Objective: The United States Food and Drug Administration implemented two exclusivity programs Competitive generic therapy and Patent Challenge exclusivity to develop generic drugs, which provide a 180-day monopoly market for first generic applicants in the United States of America. The aim of the present study is to find the root cause of failures in developing and filing the first generic drugs under these exclusivities and to compare both the exclusivities to find the merits and demerits. Methods: We used descriptive statistics for data analysis of both the exclusivities and Risk assessment was conducted on 14 industries to find the root cause of failures in every stage of the approval procedure by FMECA (Failure mode, Effects and Criticality Analysis). Results: We found 44% of rejections in competitive generic therapy drugs and 30% of rejections in patent challenge exclusivity drugs. The risk analysis conducted on failures found that, in drug selection, 6% of failures are occurred due to rare diseases. In drug development, 9% of failures are occurred due to formulation failures. In pre-approval, 10% of failures are occurred due to secondary patents. In post-approval, 6% of failures are occurred due to product changes after approval. Conclusion: We hope this study can give an idea for small and medium companies in developing countries for the early development of generic drugs for life-threatening diseases.","PeriodicalId":36282,"journal":{"name":"Acta Marisiensis - Seria Medica","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"Risk Assessment of Failures in Generic Drug Development and Approval Procedure under Competitive Generic Drug Therapy and Patent Challenge Exclusivities Provided by the United States Food and Drug Administration\",\"authors\":\"M. V. Reddy, Gnk Ganesh, B. Babu, Ramesh Jagadeesan, P. Mr\",\"doi\":\"10.2478/amma-2022-0004\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Abstract Objective: The United States Food and Drug Administration implemented two exclusivity programs Competitive generic therapy and Patent Challenge exclusivity to develop generic drugs, which provide a 180-day monopoly market for first generic applicants in the United States of America. The aim of the present study is to find the root cause of failures in developing and filing the first generic drugs under these exclusivities and to compare both the exclusivities to find the merits and demerits. Methods: We used descriptive statistics for data analysis of both the exclusivities and Risk assessment was conducted on 14 industries to find the root cause of failures in every stage of the approval procedure by FMECA (Failure mode, Effects and Criticality Analysis). Results: We found 44% of rejections in competitive generic therapy drugs and 30% of rejections in patent challenge exclusivity drugs. The risk analysis conducted on failures found that, in drug selection, 6% of failures are occurred due to rare diseases. In drug development, 9% of failures are occurred due to formulation failures. In pre-approval, 10% of failures are occurred due to secondary patents. In post-approval, 6% of failures are occurred due to product changes after approval. Conclusion: We hope this study can give an idea for small and medium companies in developing countries for the early development of generic drugs for life-threatening diseases.\",\"PeriodicalId\":36282,\"journal\":{\"name\":\"Acta Marisiensis - Seria Medica\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Acta Marisiensis - Seria Medica\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2478/amma-2022-0004\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"Pharmacology, Toxicology and Pharmaceutics\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Acta Marisiensis - Seria Medica","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2478/amma-2022-0004","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Pharmacology, Toxicology and Pharmaceutics","Score":null,"Total":0}
引用次数: 1

摘要

摘要目的:美国食品药品监督管理局(fda)实施了竞争性仿制药治疗(Competitive generic therapy)和专利挑战(Patent Challenge)两项仿制药独占计划,为美国首次申请仿制药的申请人提供了180天的垄断市场。本研究的目的是找出在这些专有权下首次仿制药开发和申请失败的根本原因,并比较两种专有权的优缺点。方法:采用描述性统计对14个行业的数据进行独占性分析和风险评估,通过FMECA (Failure mode, Effects and Criticality analysis,失效模式、影响和临界性分析)找出审批过程中各阶段失效的根本原因。结果:我们发现竞争性仿制药的拒绝率为44%,专利挑战专用性药物的拒绝率为30%。对失败进行风险分析发现,在药物选择中,6%的失败是由于罕见病造成的。在药物开发中,9%的失败是由于配方失败造成的。在预批准中,10%的失败是由于二次专利造成的。在批准后,6%的失败是由于批准后的产品变更而发生的。结论:希望本研究能为发展中国家的中小企业及早开发危及生命疾病的仿制药提供思路。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Risk Assessment of Failures in Generic Drug Development and Approval Procedure under Competitive Generic Drug Therapy and Patent Challenge Exclusivities Provided by the United States Food and Drug Administration
Abstract Objective: The United States Food and Drug Administration implemented two exclusivity programs Competitive generic therapy and Patent Challenge exclusivity to develop generic drugs, which provide a 180-day monopoly market for first generic applicants in the United States of America. The aim of the present study is to find the root cause of failures in developing and filing the first generic drugs under these exclusivities and to compare both the exclusivities to find the merits and demerits. Methods: We used descriptive statistics for data analysis of both the exclusivities and Risk assessment was conducted on 14 industries to find the root cause of failures in every stage of the approval procedure by FMECA (Failure mode, Effects and Criticality Analysis). Results: We found 44% of rejections in competitive generic therapy drugs and 30% of rejections in patent challenge exclusivity drugs. The risk analysis conducted on failures found that, in drug selection, 6% of failures are occurred due to rare diseases. In drug development, 9% of failures are occurred due to formulation failures. In pre-approval, 10% of failures are occurred due to secondary patents. In post-approval, 6% of failures are occurred due to product changes after approval. Conclusion: We hope this study can give an idea for small and medium companies in developing countries for the early development of generic drugs for life-threatening diseases.
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Acta Marisiensis - Seria Medica
Acta Marisiensis - Seria Medica Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (all)
CiteScore
0.40
自引率
0.00%
发文量
0
审稿时长
24 weeks
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信