Fennec Pharmaceuticals Inc. (NASDAQ: FENC) announced it reached a settlement agreement with Cipla Limited and Cipla USA Inc. to resolve litigation regarding Cipla's application for approval to market a generic version of PEDMARK, according to a company statement.

Under the settlement terms, the lawsuit will be dismissed with each party bearing their own costs. Cipla agreed not to enter the market with its generic sodium thiosulfate product until September 1, 2033, or earlier under certain circumstances.

The litigation stemmed from Cipla's application to the FDA for approval to market a generic version of Fennec's PEDMARK (sodium thiosulfate injection) product. The case was filed in the U.S. District Court for the District of New Jersey.

PEDMARK is approved by the FDA to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors. The drug received FDA approval in September 2022 and European Commission approval in June 2023.

Fennec holds patents providing protection for PEDMARK until 2039 in both the U.S. and internationally. The product has received Orphan Drug Exclusivity in the U.S.

The specialty pharmaceutical company focuses on commercializing treatments to reduce the risk of platinum-induced ototoxicity in cancer patients receiving cisplatin-based chemotherapy. In March 2024, Fennec entered into an exclusive licensing agreement with Norgine Pharmaceuticals Ltd. to commercialize the product in Europe, the U.K., Australia and New Zealand.