Sepracor prepared to defend patent rights for Xopenex

By Lisa Kerner

Erie, Pa., Jan. 12 - Sepracor Inc. said it plans to "vigorously defend" its patent rights for Xopenex after being notified that the Food and Drug Administration has received an Abbreviated New Drug Application from Dey, LP for a generic version of levalbuterol hydrochloride inhalation solution.

Dey's submission includes a Paragraph IV certification alleging that Sepracor's patents listed in the Orange Book for Xopenex inhalation solution are invalid, unenforceable or not infringed by Dey's proposed product, according to a company news release.

Sepracor said it believes that its patent position for Xopenex is strong.

Sepracor announced in September that the FDA had received an Abbreviated New Drug Application from Breath Ltd. for levalbuterol hydrochloride inhalation solution.

Sepracor owns five U.S. patents on methods of treating patients with levalbuterol. These patents expire between 2010 and 2013.

Sepracor's sixth patent covering stable levalbuterol formulations expires in 2021.

Sepracor is a pharmaceutical company based in Marlborough, Mass.

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