CorMedix announces issuance of U.S. patent on Defencath

CorMedix announced that the United States Patent and Trademark Office, USPTO, has issued U.S. Patent No. 11,738,120 with claims directed to the composition of a catheter lock solution for preventing infection and reduced blood flow in central venous catheters. This newly issued U.S. Patent, for which CorMedix previously announced the allowance of patent claims, reflects the unique and proprietary nature of DefenCath, and will extend the Company’s current intellectual property protection with an expiration date of April 15, 2042. The newly issued patent claims supplement CorMedix’s existing licensed U.S. Patent No. 7,696,182, and provide an additional layer of patent protection for DefenCath. The Company also expects DefenCath to be eligible for 10.5 years of statutory marketing exclusivity in the U.S. beginning upon potential FDA approval of the New Drug Application, which includes 5 years for New Chemical Entity designation, an additional extension of 5 years for Qualified Infectious Disease Product designation, and 6 months upon completion of a pediatric hemodialysis clinical trial post-approval of the NDA. As part of the NDA approval process, the Company plans to seek listing of patent No. 11,738,120 in FDA’s publication Approved Drug Products with Therapeutic Equivalence Evaluations, known as the Orange Book, which identifies approved drug products and includes related patent and exclusivity information.