Lantheus PNT2003 Lutathera Radioequivalent: 30-Month Hatch-Waxman Stay Expires June 2026, Final FDA Approval Within Reach
Lantheus's lutetium-177 dotatate ANDA (PNT2003), the first radioequivalent to Novartis's Lutathera, received FDA tentative approval on March 2, 2026; full approval is gated by the expiration of the 30-month Hatch-Waxman stay in June 2026. PNT2003 would launch into the gastroenteropancreatic neuroendocrine-tumor (GEP-NET) market alongside Lutathera and ahead of ITM-11 (Lu-edotreotide-177), which carries an August 28 PDUFA. Lantheus licensed PNT2003 from POINT Biopharma in December 2022, before Lilly's POINT acquisition.