Fennec receives FDA Orphan Drug Exclusivity for PEDMARK; 7-year market exclusivity until 2029

FENNEC PHARMACEUTICALS INC.

FDA granted Orphan Drug Exclusivity to PEDMARK, providing 7-year market exclusivity from Sept. 20, 2022 to Sept. 20, 2029.
PEDMARK is the first and only FDA-approved therapy to reduce cisplatin-induced ototoxicity in pediatric solid tumor patients.
Company holds three Orange Book patents for PEDMARK, with protection until 2038-2039.
FDA explicitly directed that PEDMARK is not substitutable with other sodium thiosulfate products.

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