On December 20th, 2024, the Court of Appeals for the Federal Circuit issued an important decision in Teva Branded Pharmaceutical Products R&D v. Amneal Pharmaceuticals that impacts Orange Book (OB) listings for patents related to FDA-approved drug/device combination products. Patentees and sponsors of New Drug Applications (NDAs) directed to drug/device combinations should review this decision to ensure that their OB listing processes comply with the standards outlined by the Federal Circuit….
By: Wolf, Greenfield & Sacks, P.C.
By: Wolf, Greenfield & Sacks, P.C.
