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news.The United States Patent and Trademark Office (USPTO) has issued a new US patent to AMAG Pharmaceuticals (AMAG) for ferumoxytol, US Patent No. 8,591,864, Polyol and Polyether Iron Oxide Complexes as Pharmacological and/or MRI Contrast Agents, expiring in March 2020.
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The patent is directed to compositions that include the chemical structure and to 500mg to 600mg unit doses of ferumoxytol and it is listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the US Food and Drug Administration (FDA).
AMAG COO Frank Thomas said, "We are pleased to announce this new patent for ferumoxytol that is especially important for the long-term value of a product that generated 28 percent revenue growth last year in the United States."
Currently, the company has five Orange Book-listed patents for ferumoxytol, with patent protection through March 2020, without patent term extension.
The company has also applied for a patent term extension for an Orange Book-listed ferumoxytol patent, which would lengthen that patent term through June 2023.
In the US, Feraheme (ferumoxytol) Injection for Intravenous (IV) use is indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have failed oral iron therapy.
The drug received marketing approval from the FDA in June 2009 for the treatment of IDA in adult chronic kidney disease (CKD) patients and was commercially launched by AMAG in the US shortly thereafter.