Time from brand drug launch to generic patent challenges U.S. 1995-2014

This statistic shows the average time from the launch of a new brand drug to the time that the patent is challenged by generic companies under paragraph IV certifications in the U.S. from 1995 to 2015. The average time from launch to having a drug patent challenged has decreased from 14.3 years as of 1995 to just 5.2 years as of 2014.

Time from launching a brand drug to meeting a paragraph IV patent challenge in the U.S. from 1995 to 2014

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Release date

July 2019


United States

Survey time period

1995, 2005, and 2014

Supplementary notes

All numbers are 3-year moving averages for brand medicines with more than $250 million in annual sales in 2008 dollars, which account for 92% of sales of the brand medicines analyzed.

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Statistics on "Generics and biosimilars"

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