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Data from: Time to market for drugs approved in Canada between 2014-2018: an observational study

Citation

Lexchin, Joel (2021), Data from: Time to market for drugs approved in Canada between 2014-2018: an observational study, Dryad, Dataset, https://doi.org/10.5061/dryad.c2fqz616t

Abstract

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.

Methods

The dataset was collected from published literature, Health Canada's Summary Basis of Decision website, Merck Index, United States Patent and Trademark Office, World Health Organization Collaborating Centre for Drugs Statistics Methodology, Government of Canadad Patent Register, and Health Canada Drug Product Database.

Usage Notes

There are no missing values. All of the information needed to generate the data used in the paper is in the dataset.