Ann: IHL Provides Shareholder Information Events for Redomiciling, page-324

Orphan Drug Exclusivity (ODE) - 7 years:
• Granted to drugs designated and approved to treat diseases or conditions affecting fewer than 200,000 in the U.S. (or
more than 200,000 and no hope of recovering costs)
• Runs from time of approval of NDA or BLA
• Bars FDA from approving any other application (ANDA, 505(b)(2) or “full” NDA or BLA) for the same drug for thesame
orphan disease or condition for seven years
• Covered under the Orphan Drug Act and 21 CFR 316.31