Posted from: Monday, October 05, 2015 - 04:26 PM - Present

Generic Exelon Patch Launched

September 10, 2015 – Alvogen announced the launch of the first generic equivalent the Exelon patch (rivastigmine transdermal system). Exelon, manufactured by Novartis, was first approved by the FDA on July 7, 2005 as a transdermal delivery system of rivastigmine, a reversible acetylcholinesterase inhibitor indicated for the treatment of mild, moderate, and severe memory problems associated with Alzheimer’s disease, and mild to moderate dementia associated with Parkinson’s disease. The generic version of the Excelon Patch will be available in three strengths (4.6mg/24 hours, 9.5mg/24 hours, and 13.3mg/24 hours) even though 13.3mg/24 hours strength has received full FDA approval. Alvogen has 180 days of marketing exclusivity for the 13.3mg/24 hours strength. It is recommended that the rivastigimine transdermal system be initiated at a dose of 4.6mg/24 hours, titrated to a dose of 9.5mg/24 hours, and could be increased to 13.3mg/24 hours due to the incidence and severity of serious stomach side effects like nausea, vomiting, and ulcers being dose related. Based on IMS data, there was approximately $400 million in U.S. sales of Norvatis’ Exelon patch in 2014.

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Last Updated Wednesday, October 16, 2019 - 03:08 PM.