FDA accepts Lantheus's application for generic Lutathera

Grandbrothers Lantheus ( NASDAQ: LNTH ) said the FDA has accepted its Abbreviated New Drug Application for a generic version of Lutathera, also known as Lutetium Lu 177 Dotatate and Lu PNT2003. The drugmaker said it believes it is the first applicant to have filed a substantially complete ANDA for the product, which would give the company 180 days of market exclusivity in the US if it is approved.

Lantheus licensed worldwide commercial rights, except for certain areas of Asia, for Lu PNT2003 from POINT Biopharma in December 2022. Lutathera is marketed by Novartis ( NVS ) in the US. POINT was recently acquired by Eli Lilly ( LLY ). The product is used to treat gastroenteropancreatic neuroendocrine tumors.

More on Lantheus Lantheus Stock: Looking To Add After SPLASH's Belly Flop Lantheus: SPLASHdown, Navigating Waves In MCRPC Treatment Lantheus Holdings: Huge Catalysts Ahead And Cheap Valuation Lantheus says FY23 worldwide revenue is expected to be in the range of $1.295 1.297B William Blair downgrades Lantheus to market perform.