DS-300

DS-300 is an injectable nutritional product for neonates. Eton Pharmaceuticals acquired exclusive U.S. rights to commercialize DS-300 from an unnamed third-party licensor on November 17, 2017. The licensor is responsible for obtaining FDA approval, while Eton handles U.S. commercialization. In December 2019, Eton filed a first-to-file Abbreviated New Drug Application (ANDA) for DS-300. An amendment to the licensing agreement in February 2020 increased Eton's share of product profits from 50% to 62.5% in exchange for Eton managing Paragraph IV litigation related to the product. The initial term of the agreement is 10 years from the first commercial sale. DS-300 is also described as an injectable DESI product, indicating it is a generic version of an older drug.