Early Launch of ORLYNVAH
Iterum Therapeutics expects to launch ORLYNVAH on August 20, ahead of the previously announced timeline, marking the first new branded product in the uncomplicated urinary tract infection space in over 25 years.
Large Addressable Market for ORLYNVAH
The U.S. uncomplicated urinary tract infection market generates approximately 40 million prescriptions annually, with about 26 million for at-risk patients, representing a significant addressable market for ORLYNVAH.
Commercial Supply and Manufacturing Agreement
Iterum has executed a commercial supply agreement with ACS Dobfar in Italy, securing a world-class FDA-approved manufacturer for ORLYNVAH with a shelf life of 6 years, satisfying commercial requirements into mid- to late 2026.
Extension of Regulatory Payment to Pfizer
The $20 million regulatory payment to Pfizer has been extended from 2026 to 2029, easing near-term financial obligations and allowing more revenue for commercialization.
Market Exclusivity and Patent Protection
ORLYNVAH has market exclusivity until 2034 and patents extending to 2041, providing a long runway to create value.