Lantheus Sued By Novartis Entities For Patent Infringement

(RTTNews) - Lantheus Holdings, Inc. Friday confirmed that the company and its subsidiary, Lantheus Medical Imaging, Inc., were sued by Advanced Accelerator Applications USA, Inc. and Advanced Accelerator Applications SA, each a Novartis entity, for patent infringement.

The lawsuit is in response to Lantheus' filing of Abbreviated New Drug Application No. 217060 for Lutetium Lu 177 Dotatate, a generic version of Lutathera.

Lutathera is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.

Lantheus said it believes it is the "first applicant" to have filed a substantially complete ANDA for Lutetium Lu 177 Dotatate, which makes it eligible for 180 days of generic marketing exclusivity in the U.S.