In our previous articles, we reported that the Federal Circuit affirmed the district court’s decision on December 20, 2024 ordering Teva Pharmaceuticals (“Teva”) to delist certain patents related to Teva’s ProAir® HFA metered-dose inhaler from the FDA’s Orange Book, and that the Federal Circuit subsequently stayed that delisting order on January 22, 2025 following a request from Teva for an en banc rehearing. On March 3, 2025, the U.S. Court of Appeals for the Federal Circuit denied Teva’s request for en banc rehearing.
With the denial of this petition, Teva is required to follow the district court’s delisting order and remove its inhaler patents — including U.S. Patent Nos. 8,132,712; 9,463,289; 9,808,587; 10,561,808; and 11,395,889 — from the Orange Book. It remains to be seen if Teva will now seek Supreme Court review.
The case is Teva Branded Pharmaceutical Products R&D Inc. v. Amneal Pharmaceuticals of New York LLC, case number 24-1936, in the United States Court of Appeals for the Federal Circuit. We will continue to monitor further developments in this case and provide insight and updates as they become available.