Data from: Time to market for drugs approved in Canada between 2014-2018: an observational study
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Objectives: This study examines the length of time between when a patent application is filed in Canada for a new drug and when it is available for patients (time to market) and various components of that time. It also looks at whether various factors explain the time between patent application to New Drug Submission and compares Canadian and American times. Drugs approved between January 1, 2014 and December 31, 2018 are examined. Design: Descriptive study Data Sources: Websites from Health Canada, Food and Drug Administration, Merck Index, United States Patent and Trademark Office, World Health Organization and previously published articles. Interventions: None Primary and Secondary Outcomes: The primary outcomes are time to market, time from patent application to New Drug Submission (pre-NDS time), review time, time from approval to availability (postapproval time) and factors that may influence the pre-NDS time. The secondary outcome is a comparison of Canadian and American review times and times between patent application and approval. Results: There were 113 drugs available for analysis. The median time to market was 11.80 years (inter-quartile range (IQR) 9.40, 14.05). The component median times were pre-NDS 10.00 years (IQR 8.05, 12.80), review time 0.96 years (IQR 0.75, 1.15) and postapproval time 0.15 years (IQR 0.08, 0.28). Less than 8% of the pre-NDS time was explained by the factors that were analyzed in a multiple linear regression equation. There was no statistically significant difference between Canadian and American pre-NDS times. Conclusion: On average, once a drug reaches the market companies have a median of 8.2 years before the patent expires and generics can reach the market. Most of the time between the filing of a patent application and when a drug is marketed is determined by decisions that are largely under the control of the company.
研究目的：本研究旨在分析新药在加拿大提交专利申请至患者可及（即上市时间（time to market））的时长及其各组成环节，同时探讨影响专利申请至新药申报（New Drug Submission）时长的各类因素，并对比加拿大与美国的相关时长。本研究纳入2014年1月1日至2018年12月31日期间获批的药品进行分析。 研究设计：描述性研究 数据来源：加拿大卫生部（Health Canada）、美国食品药品监督管理局（Food and Drug Administration）、默克索引（Merck Index）、美国专利商标局（United States Patent and Trademark Office）、世界卫生组织（World Health Organization）及已发表文献的公开数据。 干预措施：无 主要与次要结局指标：主要结局指标包括上市时间（time to market）、专利申请至新药申报（New Drug Submission）时长（以下简称pre-NDS时长）、审评时长、获批至患者可及时长（postapproval time，下称获批后时长）以及可能影响pre-NDS时长的相关因素；次要结局指标为加拿大与美国的审评时长、专利申请至获批时长的对比分析。 结果：本研究共纳入113种药品进行分析。上市时间的中位数为11.80年（四分位距（inter-quartile range，简称IQR）：9.40~14.05年）。各环节时长的中位数分别为：pre-NDS时长10.00年（IQR：8.05~12.80年）、审评时长0.96年（IQR：0.75~1.15年）、获批后时长0.15年（IQR：0.08~0.28年）。通过多元线性回归模型分析的相关因素仅可解释不足8%的pre-NDS时长变异。加拿大与美国的pre-NDS时长无统计学显著性差异。 结论：平均而言，药品上市后，企业可在中位时长8.2年内保有专利排他权，随后仿制药方可进入市场。从专利申请提交至药品上市的绝大多数时长，由企业可自主把控的决策所决定。
