The FDA issued a tentative approval for Lantheus’ abbreviated new drug application PNT2003 — a planned generic alternative to Novartis’ radioligand Lutathera — even though Novartis has active patent litigation against Lantheus and Curium. The dispute centers on multiple formulation and process patents protecting Lutathera; the case has drawn unusually broad disagreement, Judge Maryellen Noreika said during court proceedings. Under Hatch‑Waxman procedures the ANDA filing triggered infringement litigation, which could invoke patent‑related stays and a protracted legal timeline despite the tentative FDA action. Novartis’ key patent for Lutathera runs to 2038, complicating immediate market entry. The decision highlights growing tensions as radiopharmaceuticals attract generic and 505(b)(2) challengers. Outcomes will influence pricing and access for peptide‑receptor radionuclide therapies and set precedent for complex biologic‑adjacent IP battles in radiopharma.