Iterum Therapeutics, a clinical-stage pharmaceutical company, announced the filing of a US national phase patent application directed to the composition of the bilayer tablet of sulopenem etzadroxil and probenecid and its related uses with the US Patent and Trademark Office (USPTO).“If approved, this US patent application related to the bilayer tablet, which includes both sulopenem etzadroxil as well as probenecid, could provide US patent coverage for Iterum’s commercial formulation out to 2039, excluding any additional term for patent term adjustment or patent term extension, thereby extending the current patent protection afforded by the existing sulopenem etzadroxil patent estate,” said Corey Fishman, chief executive officer. “We are encouraged by the Written Opinion of the International Search Authority, which indicates that several claims directed to the composition of the tablet are novel and inventive. We anticipate additional patent filings in countries outside the US, including Europe and China, which should help facilitate partnering discussions in those regions.”The sulopenem bilayer tablet contains sulopenem etzadroxil, a prodrug of sulopenem that enables oral bioavailability, and probenecid, a renal tubular transport blocking agent, which together enhance the exposure of sulopenem to the bacterial pathogen responsible for the infection. These claims encompass the oral formulation used in the phase 3 registration studies to support the safety and efficacy of sulopenem etzadroxil and probenecid. An extension of the life of the patent estate would enable pursuit of claims related to our previously granted QIDP indications such as pneumonia
