This statistic depicts the number of orphan drugs in the U.S. that were protected by patents or other distinctions as of 2018. According to the data, 205 drug were still protected by orphan drug exclusivity and patent exclusivity.
Number of orphan drugs with patent protection and orphan drug exclusivity in the U.S. as of 2018
Characteristic
Number of drugs
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ODE = orphan drug exclusivity.
Patent protection includes other forms of market exclusivity (e.g., pediatric extension, 505(b)(2)). The 101 therapies no longer
protected by either ODE or patent exclusivity did not have generic competitors as of June 2018. The 116 therapies no longer protected by either ODE or patent
exclusivity currently have one or more generic or biosimilar competitors in the market.
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IQVIA. (December 17, 2018). Number of orphan drugs with patent protection and orphan drug exclusivity in the U.S. as of 2018 [Graph]. In Statista. Retrieved July 22, 2024, from https://www.statista.com/statistics/979753/orphan-drug-patient-protections-and-orphan-exclusivity-us/
IQVIA. "Number of orphan drugs with patent protection and orphan drug exclusivity in the U.S. as of 2018." Chart. December 17, 2018. Statista. Accessed July 22, 2024. https://www.statista.com/statistics/979753/orphan-drug-patient-protections-and-orphan-exclusivity-us/
IQVIA. (2018). Number of orphan drugs with patent protection and orphan drug exclusivity in the U.S. as of 2018. Statista. Statista Inc.. Accessed: July 22, 2024. https://www.statista.com/statistics/979753/orphan-drug-patient-protections-and-orphan-exclusivity-us/
IQVIA. "Number of Orphan Drugs with Patent Protection and Orphan Drug Exclusivity in The U.S. as of 2018." Statista, Statista Inc., 17 Dec 2018, https://www.statista.com/statistics/979753/orphan-drug-patient-protections-and-orphan-exclusivity-us/
IQVIA, Number of orphan drugs with patent protection and orphan drug exclusivity in the U.S. as of 2018 Statista, https://www.statista.com/statistics/979753/orphan-drug-patient-protections-and-orphan-exclusivity-us/ (last visited July 22, 2024)
Number of orphan drugs with patent protection and orphan drug exclusivity in the U.S. as of 2018 [Graph], IQVIA, December 17, 2018. [Online]. Available: https://www.statista.com/statistics/979753/orphan-drug-patient-protections-and-orphan-exclusivity-us/
