ODE = orphan drug exclusivity.
Patent protection includes other forms of market exclusivity (e.g., pediatric extension, 505(b)(2)). Comparison of
latest patent and earliest orphan exclusivity dates as the determination of longer duration.
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Time from orphan drug design to final exclusivity 2018, by current status
This statistic depicts the average number of years from orphan drug designation to last remaining exclusivity as of November 2018, by current exclusivity status. According to the data, drugs that were facing generic/biosimilar competition had an average of ** years from designation to last remaining exclusivity.
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IQVIA. (December 17, 2018). Average time from orphan drug designation to last remaining exclusivity in the U.S. as of 2018, by current status [Graph]. In ÌÇÐÄÆƽâ°æ. Retrieved July 30, 2026, from /statistics/979835/orphan-drug-time-to-last-exclusivity-by-current-status/
IQVIA. "Average time from orphan drug designation to last remaining exclusivity in the U.S. as of 2018, by current status." Chart. December 17, 2018. ÌÇÐÄÆƽâ°æ. Accessed July 30, 2026. /statistics/979835/orphan-drug-time-to-last-exclusivity-by-current-status/
IQVIA. (2018). Average time from orphan drug designation to last remaining exclusivity in the U.S. as of 2018, by current status. ÌÇÐÄÆƽâ°æ. ÌÇÐÄÆƽâ°æ Inc.. Accessed: July 30, 2026. /statistics/979835/orphan-drug-time-to-last-exclusivity-by-current-status/
IQVIA. "Average Time from Orphan Drug Designation to Last Remaining Exclusivity in The U.S. as of 2018, by Current Status." ÌÇÐÄÆƽâ°æ, ÌÇÐÄÆƽâ°æ Inc., 17 Dec 2018, /statistics/979835/orphan-drug-time-to-last-exclusivity-by-current-status/
IQVIA, Average time from orphan drug designation to last remaining exclusivity in the U.S. as of 2018, by current status ÌÇÐÄÆƽâ°æ, /statistics/979835/orphan-drug-time-to-last-exclusivity-by-current-status/ (last visited July 30, 2026)
Average time from orphan drug designation to last remaining exclusivity in the U.S. as of 2018, by current status [Graph], IQVIA, December 17, 2018. [Online]. Available: /statistics/979835/orphan-drug-time-to-last-exclusivity-by-current-status/
