Iterum Secures Medicare Part D Deal Covering 3.5M Lives, Gains Patent Expiring 2039
Iterum secured a rebate deal with a top-three Medicare Part D PBM, adding ORLYNVAH™ to formularies covering over 3.5 million lives starting this quarter. The US Patent No. 12,544,337 on a bilayer sulopenem-probenecid tablet was granted, expiring December 2039, while FDA requires an sNDA trial for step-down cUTI use.
1. Market Access Update
Iterum finalized a rebate agreement with one of the top three Medicare Part D Pharmacy Benefit Managers, joining existing deals with the other two. This arrangement places ORLYNVAH™ on Medicare Advantage Prescription Drug and Medicare Prescription Drug formularies, extending coverage to more than 3.5 million beneficiaries as early as this quarter.
2. Patent Portfolio Expansion
The US Patent and Trademark Office granted Patent No. 12,544,337 covering a bilayer tablet of sulopenem etzadroxil and probenecid, methods of manufacture and treatment of infections such as uncomplicated urinary tract infections. This patent, which is eligible for Orange Book listing, is set to expire in December 2039, bolstering Iterum’s intellectual property protection.
3. FDA Guidance on Step-Down Therapy
The FDA has communicated that support for ORLYNVAH™ as step-down therapy for complicated urinary tract infections will require substantial evidence of effectiveness from an adequately designed clinical trial submitted via a supplemental New Drug Application. The agency recommended that Iterum request a Type C meeting to align on trial design and endpoints for the proposed indication.