Court clears Teva’s application for generic Uceris in patent-infringement suit

JERUSALEM — A possible forthcoming generic from Teva has been cleared of a big hurdle. The U.S. District Court for the District of Delaware ruled Tuesday that the company’s application for approval of a generic of Valeant’s Uceris (budesonide) ER extended-release tablets does not infringe on Valeant’s patent.

“We are pleased to have another legal win on one of our first-to-file PIV patent challenges brought in through the Actavis Generics acquisition,” Teva president and CEO global generic medicines Dipankar Bhattacharjee said. “This presents another first generic opportunity for Teva and we look forward to offering this product to our customers when otherwise able to.”

Teva said that if it’s application is approved, its Uceris generic may be entitled to 180-day exclusivity, as it believes it was the first company to file for approval on the product. Uceris had U.S. sales of $191 million for the 12 months ended September 2017, according to QuintilesIMS data.