Amneal’s Early Win Delists Five Teva Orange Book Inhaler Patents

Teva Pharmaceuticals Industries Ltd.‘s patents for its ProAir HFA asthma inhaler must be stricken from the US Food and Drug Administration’s Orange Book, where they are listed among patents that protect name-brand drugs from generic competitors, a New Jersey federal judge ruled.

The five inhaler patents at issue are listed based on an improper interpretation of the listing statute, Judge Stanley R. Chesler found, according to an opinion and order filed Monday in the US District Court for the District of New Jersey.

“The court concludes that Teva’s patents are not properly listed in the Orange Book as a ...