US FDA “Pursuant to section 526 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bb), your orphan-drug designation request of octreotide is granted for treatment of idiopathic intracranial hypertension.” July 19, 2021
EU EMA “The medicinal product ‘Octreotide acetate’ is designated as an orphan medicinal product for the indication: Treatment of idiopathic intracranial hypertension. This medicinal product will be entered in the Community Register of Orphan Medicinal Products under number EU/3/21/2554.” December 10, 2021
Upon drug approval, Orphan Exclusivity lasts for 7 years in the U.S. and 10 years in the EU.