Posted from: Wednesday, July 17, 2019 - 08:52 AM - Present

Faslodex Generic Launched

May 30, 2019 – Sandoz has announced the launch of its generic version of AstraZeneca’s Faslodex® (fulvestrant). Fulvestrant is U.S. FDA approved for use as either a monotherapy or in combination with a CDK4/6 inhibitor to treat certain women who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

In 2016, Sandoz entered a settlement with AstraZeneca that prevented it from launching a Faslodex generic prior to March 25, 2019. At the time, Sandoz was seeking but had not yet received FDA approval for its generic. The U.S. patents for Faslodex are expected to expire in 2021.

Faslodex first received FDA approval in 2002. Sandoz’s product is the first generic version available in the United States, although additional manufacturers have sought and received FDA approval for their own generic fulvestrant products.

Sandoz’s generic is available at an average wholesale price (AWP) of $2,181.45 per box of 10 syringes, compared to $2,326.86 for the brand name.


Last Updated Thursday, October 17, 2019 - 04:05 AM.