HERTFORDSHIRE, England and PITTSBURGH: Mylan N.V. announced the U.S. launch of Rivastigmine Transdermal System, 4.6 mg/24 hrs, 9.5 mg/24 hrs and 13.3 mg/24 hrs, a generic version of Novartis’ Exelon® Patch.
Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of dementia associated with mild, moderate and severe Alzheimer’s disease and the treatment of mild to moderate dementia associated with Parkinson’s disease.
Mylan President Rajiv Malik said, “The launch of generic Exelon® Patch is another example of the investment Mylan is continuing to make into products that are difficult to develop and manufacture, particularly in transdermal drug-delivery systems. The launch of this product also strengthens the company’s growing central nervous system portfolio, which is a therapeutic area of continued focus for Mylan as we strive to provide better health for a better world.”
Rivastigmine Transdermal System, 4.6 mg/24 hrs, 9.5 mg/24 hrs and 13.3 mg/24 hrs, had U.S. sales of approximately $248 million for the 12 months ending May 31, 2018, according to IQVIA.
Currently, Mylan has 196 ANDAs pending FDA approval representing approximately $88.2 billion in annual brand sales, according to IQVIA. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $45.5 billion in annual brand sales, for the 12 months ending December 31, 2017, according to IQVIA.