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 (NDS) and compares Canadian and American times. Drugs approved between 1 January 2014 and 31 December 2018 are examined.
Design: Descriptive study.
Data sources: Websites from Health Canada, Food and Drug Administration, Merck Index, United States Patent and Trademark Office, WHO and previously published articles.
Interventions: None.
Primary and secondary outcomes: The primary outcomes are time to market, time from patent application to NDS (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 (IQR 9.40-14.05). The component median times were pre-NDS 10 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 analysed in a multiple linear regression equation. There was no statistically significant difference between Canadian and American pre-NDS times.
Conclusion: 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.
Keywords: clinical trials; health economics; health policy.
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