FDA Gives Amneal's Generic Alzheimer’s & Parkinson’s Patch a Thumbs-Up

The U.S. Food and Drug Administration (FDA) approved Bridgewater, NJ-based Amneal Pharmaceuticals’ generic version of Novartis’ Exelon Patch (Rivastigmine Transdermal System) for dementia related to Alzheimer’s and Parkinson’s diseases. The two companies were involved in patent litigation over the Exelon Patch in 2015 and 2016, but the two companies worked out a deal in October 2016. Shortly afterward, in November 2016, there were rumors that Novartis was considering acquiring Amneal for about $8 billion. This would have expanded Novartis’ Sandoz unit, which, like Amneal, focuses on generics. However, the deal never happened. The generic patch comes in three different doses, 4.6 mg/24 hours, 9.5 mg/24 hours, and 13.3 mg/24 hours. U.S. annual market for the 12 months ended November 2018 was estimated by IQVIA to be $225 million.