Barr Pharmaceuticals, Inc. confirmed that its subsidiaries, Barr Laboratories, Inc. and Pliva-Hrvatska D.O.O., have initiated a challenge of the patent listed by UCB Inc. in connection with its Xyzal tablets (levocetirizine dihydrochloride), 5mg.
The company filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic Xyzal product with the US Food & Drug Administration (FDA) in January 2008. Following receipt of the notice from the FDA that its ANDA had been accepted for filing, the company notified the New Drug Application (NDA) and patent holder.
On July 30, 2008, Sepracor Inc., UCB S.A., and UCB, Inc. filed suit in the US District Court for the Eastern District of North Carolina to prevent the company from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.
Xyzal (levocetirizine dihydrochloride) had annual sales of approximately $74 million in the US, based on IMS sales data for the twelve month period ending May 2008.
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.