DUBLIN and CHICAGO — February 13, 2026 — Leads & Copy — Iterum Therapeutics plc (Nasdaq: ITRM) provided a business update today, highlighting expanded market access and patent protection for ORLYNVAH™ and correspondence from the FDA regarding its potential use as step-down therapy.
Iterum Therapeutics, focused on delivering next-generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens, announced that it has secured another signed rebate agreement with one of the top three Medicare Part D Pharmacy Benefit Managers. This agreement, in addition to existing agreements with the other two of the top three, positions ORLYNVAH™ for inclusion on their Medicare Advantage Prescription Drug and Medicare Prescription Drug formularies. Coverage is expected to begin as early as this quarter, potentially reaching more than 3.5 million lives.
Iterum has been granted U.S. Patent No. 12,544,337, titled “Combinations of Beta-Lactam Compounds and Probenecid and Uses Thereof.” The patent covers a bilayer tablet comprising sulopenem etzadroxil and probenecid, a method of making the bilayer tablet, and methods of treating diseases, including uncomplicated urinary tract infection. The patent is projected to expire in December 2039, absent any patent term extensions and assuming timely payments of all maintenance fees. This patent is Orange Book listable, and if added, will total five U.S. patents listed in the FDA’s Orange Book.
The FDA has responded to Iterum’s request to discuss the use of ORLYNVAH™ as step-down therapy and the collection of real world data to support the proposed claim. The FDA determined that Iterum would need to provide substantial evidence of effectiveness from an adequate and well-designed clinical trial in a supplemental new drug application (sNDA) to support the proposed indication for ORLYNVAH™ as step-down treatment of complicated urinary tract infections (cUTI). The FDA recommends that Iterum request a Type C meeting to discuss the design and endpoints of any proposed clinical investigation to support the proposed indication.
Iterum Therapeutics plc is focused on delivering differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens. Iterum is advancing the development of its first compound, sulopenem, a novel penem anti-infective compound, with an oral formulation and IV formulation. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. The FDA has approved Iterum’s New Drug Application (NDA) for ORLYNVAH™ (oral sulopenem) for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women with limited or no alternative oral antibacterial treatment options and has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.
ORLYNVAH™ (oral sulopenem) is a novel oral penem antibiotic for the treatment of uUTIs. ORLYNVAH™ possesses potent activity against species of Enterobacterales including those that encode ESBL or AmpC-type ß-lactamases that confer resistance to third generation cephalosporins.
Source: Iterum Therapeutics plc
