On Friday, Lantheus Holdings, Inc. confirmed that it, along with its subsidiary Lantheus Medical Imaging, Inc., were facing a lawsuit for patent infringement. The legal action was initiated by Advanced Accelerator Applications USA, Inc., and Advanced Accelerator Applications SA, both of which are Novartis entities.
The lawsuit arises due to Lantheus' submission of Abbreviated New Drug Application No. 217060 for a generic equivalent of Lutathera, formally named Lutetium Lu 177 Dotatate.
Lutathera is a treatment designed for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). These include foregut, midgut, and hindgut neuroendocrine tumors in adults.
Lantheus believes that it is the first entity to put forward a substantially complete ANDA for the generic version of Lutetium Lu 177 Dotatate. If true, this puts them in a position to enjoy 180 days of exclusive generic marketing rights within the U.S.
