WIXOM, Mich.—The U.S. Patent and Trademark Office has issued a patent to Rockwell Medical for its propriety GMP (good manufacturing process) formulation for its iron drug Soluble Ferric Pyrophosphate (SFP).
The patent, "Methods for the Preparation and Use of Ferric Pyrophosphate Citrate Chelate Compositions," covers the synthesis and formulation for Rockwell's pharmaceutical-grade SFP formula.
The patent provides protection for Rockwell's proprietary SFP formulation through April 17, 2029. Additionally, the patent may be eligible for an extension under 35 U.S.C. 156, which is equal to the period of time from patent issuance to FDA approval. Further patent applications are pending in Europe, Japan and Canada.
SFP is a novel, investigational, continuous iron therapy in late-stage clinical development, designed to treat iron deficiency anemia in ESRD patients.
"This patent issuance is an important step in strengthening our intellectual property portfolio, while further safeguarding SFP against potential infringement. It also provides patent protection for the multiple indications Rockwell intends to develop using the SFP technology," said Robert L. Chioini, chairman, CEO and president of Rockwell Medical.
