What was filed
Advanced Accelerator Applications USA, Inc. and Novartis Pharmaceuticals Corporation v. Curium US LLC and Curium US Holdings LLC, No. 1:26-cv-14983 (D. Mass.), is a complaint filed November 5, 2026, with a jury demand. The complaint says ADACAP (Advanced Accelerator Applications USA, Inc.) markets, sells, and distributes LUTATHERA, and that Novartis Pharmaceuticals Corporation assists in marketing it. It describes LUTATHERA as a radioligand therapy, given by intravenous infusion, that treats somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, and BEXLUTRY as Curium's competing radioligand therapy for those tumors. It alleges, on information and belief, that Curium US LLC and Curium US Holdings LLC both have global headquarters in Boston, Massachusetts. Jurisdiction is pleaded under 15 U.S.C. § 1121 and 28 U.S.C. § 1331, with supplemental jurisdiction over the Massachusetts claims under 28 U.S.C. § 1367(a).
What the complaint alleges
The complaint says the FDA approved ADACAP's new drug application for LUTATHERA on January 26, 2018, and approved Curium US LLC's new drug application for BEXLUTRY on September 14, 2026, under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. It alleges that the BEXLUTRY approval did not include a determination that the two drugs are therapeutically equivalent. According to the complaint, immediately after that approval Curium began making equivalence claims on its BEXLUTRY website for healthcare providers, and made similar statements in a September 14, 2026, press release. The complaint quotes the website as calling BEXLUTRY "[t]he FDA-approved lutetium Lu 177 dotatate radioligand equivalent" and "the FDA-approved Lutetium Lu 177 dotatate with equivalent clinical benefits," and as stating that "BEXLUTRY established clinical equivalence through the FDA’s 505(b)(2) approval pathway." The complaint alleges these statements falsely convey that the FDA has determined BEXLUTRY is equivalent to LUTATHERA and that reliable studies show the two drugs have equivalent clinical benefits. It alleges, on information and belief, that "radioligand equivalent" is a term of Curium's own invention, and, on information and belief, that the challenged advertising was willfully made with knowledge of its falsity and intent to deceive consumers.
The counts and relief
Count One alleges false advertising and unfair competition under Section 43(a) of the Lanham Act, 15 U.S.C. § 1125(a). It also alleges that Curium's claim that BEXLUTRY is a radioligand equivalent "supported by published evidence and targeted bridging data" is a false establishment claim, conveying that reliable scientific evidence shows the two drugs are clinically or therapeutically equivalent. Count Two alleges unfair and deceptive trade practices under Mass. Gen. Laws Ann. ch. 93A, §§ 2 and 11, and pleads the establishment-claim theory on information and belief. Count Three alleges commercial disparagement under Massachusetts common law. The prayer asks for judgment on each count; a preliminary and permanent injunction against advertising that falsely communicates that the FDA has determined BEXLUTRY to be "equivalent" to LUTATHERA, and that evidence and data show the two drugs are equivalent; damages, multiple damages, and attorneys' fees under 15 U.S.C. § 1117(a) and Mass. Gen. Laws Ann. ch. 93A, § 11; the defendants' profits, including enhanced amounts under § 1117(a); costs and attorneys' fees; pre- and post-judgment interest; and other relief.
Docket
Through November 6, 2026, the docket shows the complaint, a corporate disclosure statement, four pro hac vice filings, a report on the filing of a patent or trademark case, a notice of case assignment to a magistrate judge, another clerk's notice, and a refusal to consent to proceed before a magistrate judge. No district judge appears on the docket yet. Watch for a judge assignment, service on the Curium defendants, and their response to the complaint.