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news.Barr Pharmaceuticals' subsidiary Barr Laboratories has received tentative approval from the FDA for its generic version of Janssen Pharmaceutica Products' dementia drug Razadyne 4mg, 8mg and 12mg tablets.
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The FDA cannot give final approval until a dispute with Janssen, the new drug application (NDA) holder, Synaptech, the patent owner, and Barr is resolved. In June 2005, Janssen and Synaptech filed suit against Barr Laboratories in the District Court of Delaware to formally initiate the patent challenge process. Trial is set for May 21, 2007.
Razadyne is indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. The product had annual sales of approximately $140 million for the twelve months ending March 2007, according to IMS sales data.