Sepracor Sues Barr Over Generic Xopenex Plans

Sepracor initiated a lawsuit against Barr Laboratories after Barr filed an abbreviated new drug application (ANDA) seeking approval for a generic version of Sepracor’s asthma treatment Xopenex, Barr confirmed this week.

Barr said it submitted its ANDA containing Paragraph IV certification seeking to market generic Xopenex (levalbuterol HCl) in March, and the FDA accepted its application in May. Barr then notified the patent owner.

Sepracor filed suit July 12 in the U.S. District Court for the District of Delaware. Sepracor alleges that Barr’s product would infringe on its various method-of-use patents covering Xopenex. The company is asking the court to enjoin Barr from making generic Xopenex and to rule that Barr’s ANDA may not be approved until the last of its Xopenex patents expire, according to the complaint.

Xopenex is an inhaled product indicated for the treatment or prevention of bronchospasm in adults, adolescents and children over age 6 with reversible obstructive airway disease. The product had U.S. sales of approximately $609 million during the 12-month period that ended in May, Barr said, citing IMS Health data.