Breckenridge Announces Final Approval of ANDA for Rivastigmine Transdermal System

Breckenridge Pharmaceutical announced the U.S. Food and Drug Administration (FDA) has granted final approval for its Abbreviated New Drug Application for Rivastigmine Transdermal System in 4.6mg/24 hours, 9.5mg/24 hours and 13.3mg/24 hours strengths (generic for Exelon® Patch by Novartis). Breckenridge's Rivastigmine Transdermal System was developed in collaboration with Welding GMBH & Co. KG and SK Chemicals Co. Exelon® Patch and its therapeutic equivalents generated annual sales of $161 million during the twelve months ending September 30, 2019, according to industry sales data. Breckenridge plans to launch the product immediately.

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