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news.The US Patent and Trademark Office (USPTO) has awarded a patent to Rockwell Medical in relation to product claims that require its anemia drug Soluble Ferric Pyrophosphate (SFP) dissolved in a bicarbonate solution held in a polyolefin container, such as an HDPE container.
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SFP is an investigational, continuous iron therapy in late-stage clinical development designed to treat end-stage renal disease (ESRD) patients.
Clinical trial data suggests that SFP, delivered via dialysate during each dialysis treatment, maintains optimal iron balance and avoids liver toxicity while decreasing associated drug administration costs.
The patent, ‘Packaging of Ferric Pyrophosphate for Dialysis,’ also includes method claims using the claimed product.
The patent provides protection through 2029.
Additionally, the patent may be eligible for an extension under 35 USC 156, which is equal to the period of time from patent issuance to FDA approval.