Bayer Sues Johnson & Johnson Over Competing Prostate Cancer Drug Marketing Claims

Whippany-based Bayer filed a federal lawsuit against New Brunswick-headquartered Johnson & Johnson, alleging the rival pharmaceutical company falsely advertised its competing prostate cancer drug in ways that harm Bayer’s own product sales.

The complaint, filed February 23 in U.S. District Court for the Southern District of New York, claims J&J’s new marketing campaign for its drug Erleada threatens to damage trust and sales prospects for Bayer’s competing medication Nubeqa, according to court documents.

Bayer alleges that J&J made “false claims regarding the efficacy of Nubeqa … in an effort to increase its market share in a concentrated and increasingly competitive prostate cancer treatment market,” the lawsuit states.

The dispute centers on a February 2 press release from J&J that promoted what the company called a “real-world head-to-head analysis” comparing survival rates between patients treated with either Erleada or darolutamide, the active ingredient in Nubeqa, according to the complaint.

J&J’s retrospective analysis of U.S. medical and insurance databases concluded that patients with metastatic castration-sensitive prostate cancer who first received Erleada experienced a 51% reduction in risk of death compared to those who initially received Nubeqa, according to the company’s findings.

The analysis showed that about 92% of 1,460 Erleada patients were still living at the 24-month mark, compared to just under 86% of 287 Nubeqa patients, according to J&J’s data.

J&J has promoted these findings through a slideshow presentation and on its Medical Connect website for healthcare providers, according to Bayer’s complaint.

Bayer disputes the validity of J&J’s comparison, arguing that the two patient groups weren’t truly comparable because most Nubeqa patients were treated off-label, creating selection bias that undermines any superiority claim, according to the lawsuit. Bayer also noted that J&J’s study included five times as many patients.

The complaint argues that the U.S. Food and Drug Administration does not sanction the retrospective, real-world analysis that J&J used as a substitute for traditional clinical trials, according to Bayer.

Bayer also claims that online searches, including AI-generated summaries in Google, are repeating J&J’s claims that Erleada is superior and that Nubeqa carries a higher risk of death, according to the lawsuit.

The legal action followed J&J’s “refusal to cease and desist its promotion of a scientifically flawed real-world evidence analysis that misinforms healthcare providers and patients,” according to Bayer’s complaint.

Bayer maintains that J&J’s claims violate the federal Lanham Act, which prohibits companies from making false or misleading statements about a product’s safety, efficacy or characteristics, according to the lawsuit.

The pharmaceutical company seeks a permanent injunction stopping J&J from disseminating the analysis and its claims, as well as an order requiring J&J to issue a “corrective press release” dispelling the claims, according to court documents.

Bayer also requests that J&J pay “unjust profits,” compensatory and threefold punitive damages, and court costs, according to the lawsuit.

Both drugs are androgen receptor inhibitors used to slow prostate cancer growth. Nubeqa won initial FDA approval in 2019 and received expanded approvals in 2022 and 2025, according to regulatory records. Erleada received its first FDA approval in 2018 with expanded approval in 2019.

The financial stakes are substantial. Nubeqa generated approximately $1.92 billion in sales during the first nine months of 2025, while Erleada pulled in $2.62 billion over the same period, according to company reports.

The lawsuit comes shortly after both companies launched competing marketing campaigns, with Bayer unveiling a Nubeqa promotion featuring NFL quarterback-turned-commentator Tony Romo just before J&J’s Erleada campaign began last month, according to the complaint.