“Based on the most recent update to the FDA’s online paragraph IV database listings,1 Lantheus believes it is the first applicant to have filed a substantially complete ANDA for Lutetium Lu 177 Dotatate containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Should its ANDA be approved by the FDA, Lantheus believes it will be eligible for 180 days of generic marketing exclusivity in the U.S. Lantheus licensed exclusive worldwide commercialization rights (excluding certain Asian territories) to 177Lu-PNT2003 from POINT Biopharma Global, Inc. in December of 2022.”
