The FDA issued a tentative approval for Lantheus’ ANDA for PNT2003, a generic version of Novartis’ radioligand therapy Lutathera (lutetium Lu 177 dotatate), while Novartis continues active patent litigation. Lantheus filed the abbreviated new drug application under the Hatch‑Waxman framework and now faces a multi‑patent infringement suit from Novartis that could determine whether tentative approval becomes final. Legal experts note the dispute is unusually complex for an ANDA case because radiopharmaceuticals rely heavily on formulation and process patents. The litigation will determine if Lantheus can bring a lower‑cost alternative to market before Lutathera’s patents expire in 2038. A final outcome would reshape competition in radiopharmaceuticals and could influence pricing and access for somatostatin receptor–positive neuroendocrine tumor therapies worldwide.