Barr Pharmaceuticals, Inc confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by TAP Pharmaceuticals Inc. in connection with its Prevacid SoluTab delayed-release orally disintegrating tablets (lansoprazole), 15mg and 30mg.
Barr filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic Prevacid SoluTab product with the US Food & Drug Administration (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 (NDA) and patent holder.
On June 9, 2008, Ethypharm, SA, Takeda Pharmaceutical Co., Ltd. and TAP Pharmaceuticals Inc. filed suits in the US District Court for the District of Delaware to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.
Prevacid SoluTab (lansoprazole) had annual sales of approximately $428 million in the US, based on IMS sales data for the 12-month period ending March 2008.