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doi:10.1530/eje.0.1390552PMID:9849822 [4] Gobburu JV, Agers H, Jusko WJ, Ynddal L

The mean diameter of cardiomyocytes

10.1016/j.bmc.2014.04.016 81

For a compound whose CoM has expired, orphan drug designation creates a new exclusivity window that no generic can challenge via an ANDA the exclusivity is regulatory, not patent-based, and it blocks approval of the same drug for the same orphan indication