Upcoming Launch of ORLYNVAH
Iterum Therapeutics is set to launch ORLYNVAH around August 20, 2025, ahead of the previously announced timeline. This is significant as it will be the first new branded product launched in the uncomplicated urinary tract infection space in over 25 years.
Market Potential and Addressable Market
The uncomplicated urinary tract infection market in the U.S. generates approximately 40 million prescriptions annually. ORLYNVAH targets at-risk patients, approximately 26 million prescriptions annually, who are most in need of new therapies.
Strategic Geographic Launch Plan
The first phase of the launch will cover 20 targeted geographic territories in 7 states with a focus on high-value physician prescribers. These include New York, New Jersey, Connecticut, Pennsylvania, Georgia, Florida, and Texas.
Strong Manufacturing and Supply Agreement
Iterum has executed a commercial supply agreement with ACS Dobfar, a leading manufacturer, ensuring a world-class FDA-approved manufacturer for ongoing production. The current stock is expected to satisfy commercial requirements into mid-to-late 2026.
Extended Market Exclusivity and Patent Protection
ORLYNVAH has been granted market exclusivity in the U.S. until October 2034, with patents scheduled to expire between 2039 and 2041, providing a long runway for value creation.
Financial Extension Agreement with Pfizer
The $20 million regulatory payment to Pfizer has been extended to October 2029, removing a near-term financial obligation and allowing more revenue to be used for ORLYNVAH commercialization.