Court of Appeal upholds District Court decision on Par Pharma's Exelon generic

The US Court of Appeals for the Federal Circuit has upheld the District Court of Delaware’s earlier ruling on Par Pharmaceuticals’ generic of Exelon (rivastigmine transdermal system), manufactured by Swiss pharma giant Novartis (NOVN: VX).

Par’s filing of an Abbreviated New Drug Application for the generic of Novartis’ Exelon patch does not infringe US Patent numbers 6,316,023 or 6,335,031, according to the court. The appeals court also affirmed the district court’s finding that the patents are not invalid. This means Par can launch its product upon receiving final approval from the US Food and Drug Administration.

The patch is used for the treatment of mild, moderate and severe Alzheimer’s disease-related dementia, and mild to moderate dementia related to Parkinson’s disease. IMS Health data puts annual US sales of Exelon at $626 million.