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CorMedix Inc. Announces Notice of Allowance for U.S. Patent Application Covering Lead Product DefenCath
BERKELEY HEIGHTS, N.J., May 01, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing
About this update from Cormedix Inc.
[{"type":"text","content":"BERKELEY HEIGHTS, N.J., May 01, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced that the United States Patent and Trademark Office (USPTO) allowed its patent claims directed to the composition of a catheter lock solution for preventing infection and also preventing reduced blood flow in central venous catheters. CorMedix’s newly allowed U.S. Patent Application (No. 17/721,699) reflects the unique and proprietary formulation of its product, DefenCath™, for which the Company expects to resubmit its New Drug Application (NDA) to the Food and Drug Administration (FDA) by mid-May. Joe Todisco, CorMedix CEO stated, “We are pleased to have received this Notice of Allowance that highlights the novelty of DefenCath which has been formulated and demonstrated in clinical trials to reduce Catheter Related Bloodstream Infections (CRBSIs) in hemodialysis patients with central venous catheters. As we updated last week, CorMedix intends to resubmit the DefenCath NDA by mid-May and is focused on building out plans for commercialization following an anticipated FDA approval later this year.” The newly allowed application provides patent coverage that supplements CorMedix’s existing licensed U.S. Patent No. 7,696,182, and has the potential to provide an additional layer of patent protection for DefenCath through 2042. 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 NDA, 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 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. About CorMedix CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-thre...