In our previous article, we reported that the Federal Circuit affirmed the district court’s decision requiring Teva to delist certain patents related to its Teva’s ProAir® HFA metered-dose inhaler from the FDA’s Orange Book. Following a request from Teva for an en banc rehearing, the Federal Circuit stayed the delisting order on January 22, 2025. This stay delays the delisting of Teva’s patents from the Orange Book, allowing Teva to maintain its current patent listings pending resolution of the petition for rehearing en banc. The outcome of this en banc rehearing will have significant implications for both brand name drug product developers and generic drug developers. We will continue to monitor further developments in this case and provide insight and updates as they become available.
