Sepracor, UCB file suit against Perrigo partner

ALLERGAN, Mich. A generic pharmaceutical company has filed for Food and Drug Administration approval of a generic version of a drug used to treat allergies and hives, provoking a lawsuit by the companies that control the branded version.

Perrigo Co. announced Wednesday that its partner, Synthon Pharmaceuticals, had filed for approval of levocetirizine solution in the 2.5-mg per 5-ml strength. The drug is a generic version of Sepracor’s and UCB’s Xyzal, which has sales of about $10 million a year, according to Wolters Kluwer Health data.

In response to the approval application, UCB and Sepracor filed suit against Synthon in the U.S. District Court for the Eastern District of North Carolina, alleging patent infringement. Synthon’s application contained a Paragraph IV certification, asserting that Sepracor’s patent is invalid, unenforceable or won’t be infringed by a generic version of Xyzal. As presumably the first company to seek approval for a generic version, Synthon could receive 180 days of market exclusivity after obtaining final approval from the FDA.