ITRM Broadens Market Access with ORLYNVAH as Coverage Now Reaches 60 Million Insured Lives
Reimbursement Expansion Accelerates as 25% of U.S. Insured Lives Gain Access
Iterum Therapeutics (NASDAQ: ITRM) has made major headway with its oral antibiotic ORLYNVAH™. As of December 5, the company’s flagship drug has gained coverage for nearly 25% of insured lives in the U.S., equivalent to more than 60 million people. This rapid growth comes from increasing adoption by both commercial payers and government programs, including key state Medicaid plans and large insurance networks.
| Coverage Milestone | Insured Lives Covered (millions) | Major Payers / Channels |
|---|---|---|
| National Coverage Expansion | 60 | Blue Cross Blue Shield, Aetna, California & NY Medicaid, Veterans Affairs/Tricare |
| Medicare Part D (starting Q1 2026) | TBD (significant, top 3 PBM) | Medicare Advantage Rx Drug Plans |
| Specialty Distributor Access | - | McKesson, Cencora |
Key PBM and Medicare Milestones Set Up Long-Term Growth
One standout update is Iterum’s new rebate agreement with a leading Medicare Part D pharmacy benefit manager, which sets ORLYNVAH up for broader inclusion on Medicare prescription drug formularies as soon as early 2026. This gives Iterum a foothold in the crucial senior market—where urinary tract infections are a persistent and costly problem—and cements its competitive positioning with both commercial and government payers.
Specialty Distribution Expansion Enhances Physician Access
Beyond reimbursement, ORLYNVAH is now stocked at major specialty distributors McKesson and Cencora, making it easier for healthcare providers to directly obtain the product according to their practice needs. This expanded distribution is a practical step that can improve prescription fill rates and patient outcomes as payer coverage widens.
Patent Strength in Europe Adds Protection Through 2039
Iterum also announced that the European Patent Office will soon grant a patent covering the bilayer formulation of sulopenem and probenecid (the components of ORLYNVAH), protecting its product until December 2039. Strong patent coverage in the U.S. and abroad gives Iterum strategic leeway for both commercialization and partnering discussions going forward.
Focus Remains on Combatting Drug-Resistant Infections
Iterum’s business model is rooted in fighting antibiotic resistance with next-generation therapies. ORLYNVAH has FDA approval for complicated urinary tract infections in adult women who have limited alternatives—a clear and urgent unmet medical need. Recent milestones reflect not only operational progress but a response to persistent demand for new options against resistant bacteria.
Investor Takeaway: Coverage Wins May Unlock Near-Term Value
Iterum’s rapid market access gains, strategic PBM wins, and extended European patent protection present an evolving opportunity for stakeholders. As ORLYNVAH transitions into wider use—with expected Medicare expansion in early 2026 and continued pharmacy adoption—investors and clinicians alike will be watching for signs of commercial momentum and long-term franchise value.
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