Ferumoxytol is protected in the U.S. by three issued patents covering the composition and dosage form of the product. Each issued patent is listed in the FDA’s Orange Book. These patents are set to expire in 2020; a request for patent term extension has been filed, which, if granted, may extend the patent term to 2023 for one of the patents.Ferumoxytol received marketing approval in Canada in December 2011, where it is marketed by Takeda as Feraheme, and in the European Union in June 2012 and Switzerland in August 2012, where it is marketed by Takeda as Rienso®.
AMAG Pharmaceuticals Announces Positive Preliminary Results From An Extension Study Evaluating The Safety And Efficacy Of Repeat Dosing With Ferumoxytol In Patients With Persistent Or Recurring Iron Deficiency Anemia, Regardless Of The Underlying Cause
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