Spectrum Pharmaceuticals, a biotechnology company, has settled its ANDA patent litigation relating to Folotyn (pralatrexate injection). As a result of the settlement with the last remaining ANDA filer, Fresenius Kabi USA, LLC, and the previously reported settlements with Teva Pharmaceuticals USA, Inc., Dr Reddy's Laboratories, Ltd. & Dr Reddy's Laboratories, Inc. and Sandoz Inc., absent certain circumstances, generic versions of Folotyn will not be permitted to be marketed in the United States until November 15, 2022.
The company will submit the settlement agreement to the Federal Trade Commission and the Department of Justice. Details of the settlement are confidential.
Spectrum Pharmaceuticals is a leading biotechnology company focused on acquiring, developing, and commercializing drug products, with a primary focus in hematology and oncology.