Generics to Become Available for Epclusa and Harvoni

December 1, 2018 – According to Asegua Therapeutics, a subsidiary of Gilead Sciences, generic versions of Epclusa® (sofosbuvir/velpatasvir) and Harvoni® (ledipasvir/sofosbuvir) should be available on the U.S. market in January 2019. Both Epclusa and Harvoni are Gilead products, and Asegua’s generics will be considered authorized generics.

The U.S. FDA first approved Harvoni in 2014, and Epclusa in 2016. Harvoni is indicated to treat chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6 infection in certain adult and pediatric patients. Epclusa is approved to treat certain adult patients only who have chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection.

The expected list price for both generics is $24,000 per course of treatment.