Breckenridge gets FDA clearance for generic Exelon Patch

Breckenridge has received the Food and Drug Administration’s green light for rivastigmine transdermal system in dosage strengths of 4.6mg/24 hours, 9.5mg/24 hours and 13.3mg/24 hours.

The product is the generic of Novartis’ Exelon Patch. 

Breckenridge's product was developed in collaboration with Welding GMBH & Co. KG and SK Chemicals. 

The Exelon Patch and its generics had a market value of $161 million during the 12 months ended Sept. 30, 2019, according to industry sales data.

Breckenridge plans to launch the product immediately.