MONTVALE, N.J., June 10 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) today confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by TAP Pharmaceuticals Inc. in connection with its Prevacid(R) SoluTab(TM) 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 U.S. 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, S.A., Takeda Pharmaceutical Co., Ltd. and TAP Pharmaceuticals Inc. filed suits in the U.S. 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 U.S., based on IMS sales data for the 12-month period ending March 2008.
About Barr Pharmaceuticals, Inc.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company
that operates in more than 30 countries worldwide and is engaged in the
development, manufacture and marketing of generic and proprietary
pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients.
A holding company, Barr operates through its principal subsidiaries: Barr
Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its
subsidiaries. The Barr Group of companies markets more than 120 generic and
|SOURCE Barr Pharmaceuticals, Inc.|
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