The FDA issued a tentative approval for Lantheus’ ANDA for PNT2003, a generic version of Novartis’ radioligand Lutathera (lutetium Lu 177 dotatate). Lantheus, Novartis and Curium are now locked in litigation over formulation and process patents, and a Delaware federal judge has flagged the case’s unusually large number of disputes. Under Hatch‑Waxman rules a tentative approval does not translate into market entry while active patent litigation persists. The development signals rising competition pressure in the radiopharmaceutical space and underscores how formulation/process patents, not new molecules, are shaping exclusivity for radioligand therapies.