AMAG Pharmaceuticals, Inc., a specialty pharmaceutical company, announced that the United States Patent and Trademark Office (USPTO) has issued a US patent term extension certificate extending the term of US Patent No. 6,599,498 by 1,209 days. With this extension the '498 patent will now expire June 30, 2023. This patent is directed to reduced polysaccharide iron oxide complexes, including ferumoxytol. The '498 patent is listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the United States Food and Drug Administration.
The patent term extension certificate was granted under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984. The patent term certificate extends the term of the '498 patent from its original expiration date of 2020.
"This patent extension for ferumoxytol further lengthens our intellectual property protection and enhances the long-term value of a product that generated 28 per cent revenue growth in the US in 2013 for our company," said William Heiden, chief executive officer of AMAG.
AMAG has five Orange Book-listed patents relating to ferumoxytol, including the '498 patent.
In the United States, 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. Feraheme received marketing approval from the FDA on June 30, 2009 for the treatment of IDA in adult chronic kidney disease (CKD) patients and was commercially launched by AMAG in the US shortly thereafter.
Ferumoxytol is protected in the US by five 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 March 2020, with one patent expiring in June 2023.
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, Inc. is a specialty pharmaceutical company that markets Feraheme (ferumoxytol) Injection and MuGard Mucoadhesive Oral Wound Rinse in the United States.