Abstract
Time to Marketing of Generic Drugs After Patent Expiration in Canada
Highlights
Pharmaceutical companies argue that 20-year patent protection is not long enough to compensate for the time spent in drug development and the regulatory process
For drugs with generic competition, the mean time for market exclusivity until patent expiration was 8.08 years
The mean time from patent expiration until generic drug marketing was 1.53 years, for a mean difference of 9.61 years between the start of brand name and generic drug marketing
Summary
Pharmaceutical companies argue that 20-year patent protection is not long enough to compensate for the time spent in drug development and the regulatory process. Patents in the United States can be extended for up to 5 years or a maximum of 14 years after US Food and Drug Administration approval.[1] Canada offers up to 2 extra years of patent protection.[2] One previous Canadian study examined the time to generic competition but used approval dates rather than actual marketing dates.[3] The objectives of this study using marketing dates were to: 1. 2. Calculate the following times: brand name marketing to patent expiration, patent expiration until generic marketing, and brand name to generic marketing for drugs with generic competition
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