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The basics:

• Bayer sued Johnson & Johnson over advertising claims tied to prostate cancer drug Erleada
• Lawsuit alleges false claims harmed sales of Bayer’s Nubeqa
• Dispute centers on real-world data showing a 51% lower death risk with Erleada
• Bayer seeks injunction, corrective statement and monetary damages under the Lanham Act

Whippany-based Bayer is suing New Brunswick-headquartered Johnson & Johnson over claims the rival pharmaceutical company falsely advertised a competing prostate cancer drug.

In a complaint filed Feb. 23 in U.S. District Court for the Southern District of New York, Bayer said the new marketing campaign for Erleada is causing irreparable harm that threatens to erode trust and sales prospects in its own Nubeqa.

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.”

For evidence, Bayer cited a Feb. 2 press release from J&J in which the firm touted a “real-world head-to-head analysis” comparing overall survival rates after 24 months in patients treated either with Erleada or with darolutamide – the active ingredient in Nubeqa – both without the chemotherapy docetaxel.

Alleged Lanham Act violations

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

At the 24-month mark, about 92% of the 1,460 Erleada patients included in the analysis were still living, compared to just under 86% of 287 Nubeqa patients, J&J said.

The company has also promoted the findings in a slideshow presentation and on its Medical Connect website for health care providers, according to Bayer. The pharmaceutical company said its 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 the lawsuit, Bayer believes the two patient groups weren’t truly comparable because most Nubeqa patients were treated off-label, creating selection bias that undermines any superiority claim. It also noted J&J’s study included five times as many patients.

Bayer also said the U.S. Food and Drug Administration does not sanction the retrospective, real-world analysis that Johnson & Johnson allegedly used as a substitute for traditional clinical trials.

Additionally, the complaint argues that online searches, including ones through AI-generated summaries in Google, are repeating or amplifying J&J’s claims that Erleada is better and Nubeqa carries a higher risk of death.

Bayer’s complaint maintains that the nature of J&J’s claims regarding Nubeqa’s efficacy violate the Lanham Act. Under that federal law, companies are prohibited from making false or misleading statements about a product’s safety, efficacy or characteristics.

What Bayer wants

In the lawsuit, Bayer requested a permanent injunction stopping J&J from disseminating the analysis and its claims, as well as an order for its rival to put out a “corrective press release” dispelling the claims.

Additionally, the lawsuit seeks a judgment that would order J&J to pay Bayer its “unjust profits,” as well as compensatory and threefold punitive damages and reimbursement for court costs.

Both Erleada and Nubeqa are androgen receptor inhibitors used to slow prostate cancer growth, often alongside other treatments.

A key product for Bayer, Nubeqa won initial approval from the FDA in 2019. It was then OK’d for expanded uses in 2022 and 2025. One of J&J’s faster-growing oncology products, Erleada received its first FDA approval in 2018 and then expanded approval in 2019.

Nubeqa sales totaled about $1.92 billion in the first nine months of 2025, while Erleada pulled in $2.62 billion over the same period.

‘Litigation does not change data’

Shortly before J&J launched its advertising campaign for Erleada last month, Bayer unveiled a marketing push for Nubeqa that included a partnership with NFL quarterback-turned-sports commentator Tony Romo. The effort included a series of online videos in which Romo talks with a patient taking Nubeqa, a caregiver of a person with advanced prostate cancer and an oncologist.

In a statement to NJBIZ, J&J said, “Johnson & Johnson stands by the rigor and integrity of our real-world, head-to-head analysis that shows a 51% reduction in risk of death for patients with metastatic castration-sensitive prostate cancer treated with ERLEADA (apalutamide) versus darolutamide without docetaxel through 24 months. Litigation does not change data.”

The company also said, “Our analysis was designed to meet rigorous regulatory guidance on real-world evidence, and this legal action demonstrates Bayer’s obvious misunderstanding of methodological frameworks and real-world evidence principles.”