Barr filed its abbreviated new drug application (ANDA) containing a paragraph IV certification for a generic Prevacid SoluTab product with the FDA in November 2007. Following receipt of the notice from the FDA that Barr’s ANDA had been accepted for filing, Barr notified the new drug application and patent holder.
On June 9, 2008, Ethypharm, Takeda Pharmaceutical and TAP Pharmaceuticals filed suits in the US District Court of Delaware to prevent Barr from proceeding with the commercialization of its product.