The FDA issued a tentative approval for Lantheus’ ANDA for PNT2003, a potential generic version of Novartis’ radioligand Lutathera (lutetium Lu 177 dotatate), while active patent litigation continues. Novartis sued Lantheus in 2024 for alleged infringement across multiple patents, setting up an extended Hatch‑Waxman style dispute. The case exposes unique IP fault lines in radiopharmaceuticals, where formulations and process patents, not novel antibodies, often protect market exclusivity. Legal proceedings in Delaware and the statutory patent‑challenge timelines will determine whether tentative approval converts into full market entry. Sources: FDA tentative approval notice, Delaware District Court filings and legal expert commentary.