Savient Pharmaceuticals filed a lawsuit against Barr Laboratories (BRL) in New Jersey federal court for infringing patents related to Savient's Oxandrin drug, which promotes weight gain after surgery or trauma.
Barr plans to market a generic version of the drug, and has filed an Abbreviated New Drug Application with the Food and Drug Administration.
Barr said later Tuesday it filed its ANDA with the FDA in June 2006, and received notification of the application's acceptance for filing in August 2006. After receiving notice from the FDA, Barr notified Savient, the patent owner and New Drug Applications holder.
Barr said it believes it is the first to file an ANDA with the FDA for the product.
Oxandrin had annual sales of approximately $62 million for the twelve months ended July 2006, according to Barr's citation of IMS sales data.
Shares of Barr closed Tuesday up 74 cents to $51.70.