Amneal Announces Approval of Rivastigmine Transdermal System

Amneal Pharmaceuticals has received FDA approval for a generic version of Exelon Patch (Rivastigmine Transdermal System), 4.6 mg/24 hours, 9.5 mg/24 hours, and 13.3 mg/24 hours. The company is planning to commercialize its Rivastigmine Transdermal System shortly.

"We are pleased to receive approval on the company's first transdermal product, which demonstrates our commitment to develop and bring to market complex generic products," said Rob Stewart, President and CEO of Amneal. "Our diverse pipeline of approximately 220 products is expected to deliver additional complex product approvals this year and help us achieve our goal of launching up to 50 generic products in 2019."

According to IQVIA, U.S market annual sales for the 12 months ended November 2018 for Rivastigmine Transdermal System is estimated to be approximately $225 million.

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