On November 24, 2025, the U.S. District Court for the District of New Jersey entered a Consent Judgment and Injunction resolving the denosumab BPCIA litigation between Amgen, Inc. and Amgen Manufacturing Limited (“Amgen”), Hikma Pharmaceuticals USA Inc. (“Hikma”), and Gedeon Richter Plc., Gedeon Richter (Schweiz) AG, and Gedeon Richter USA, Inc. (“Gedeon”). The Consent Judgment and Injunction recognizes that Amgen, Hikma, and Gedeon have entered into a confidential settlement agreement, and that as part of the agreement, Hikma and Gedeon agreed to the entry of judgment and an injunction. Hikma and Gedeon agreed to be enjoined from selling their denosumab biosimilar products until January 1, 2026, at which time the injunction expires.
As we reported previously, Amgen filed its BPCIA complaint against Hikma and Gedeon on June 25, 2025, alleging that Hikma and Gedeon’s denosumab biosimilars would infringe 32 patents. Hikma and Gedeon received FDA approval on September 26, 2025, for ENOBY (denosumab-qbde) and XTRENBO (denosumab-qbde), referencing Amgen’s PROLIA and XGEVA, respectively.
This settlement follows Amgen’s settlement of denosumab litigations with Celltrion, Sandoz, Fresenius, Accord, Samsung Bioepis, and Biocon. Amgen’s denosumab BPCIA litigations against Alkem, Dr. Reddy’s/Alvotech, Amneal, and Shanghai Henlius Biotech remain pending.
Stay tuned to Big Molecule Watch and follow our BPCIA Litigations Tracker to stay up to date on denosumab and other BPCIA litigation news.