Rockwell Medical (Nasdaq:RMTI), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia, announced today that it has received notice from the U.S. Patent and Trademark Office for patent issuance on its proprietary GMP formulation for Soluble Ferric Pyrophosphate (SFP), the Company's lead-drug candidate for treating iron deficiency anemia in ESRD patients.
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.
"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," stated Robert L. Chioini, Chairman, CEO and President of Rockwell Medical.