Bayer AG initiated legal action Monday in the U.S. District Court in New York, accusing Johnson & Johnson of airing false and deceptive advertisements that the suit says damage sales prospects for Bayer’s prostate cancer therapy Nubeqa.
At issue is J&J’s February 2026 marketing effort asserting that Erleada demonstrated a 51% reduction in the risk of death compared with Nubeqa based on what J&J described as a "real world head-to-head analysis." Bayer has asked the court to order J&J to retract or correct those representations.
Both medicines are androgen receptor inhibitors administered alongside androgen deprivation therapy (ADT) to treat metastatic castration-sensitive prostate cancer, a condition noted in the complaint as responsible for more than 35,000 deaths annually in the United States.
Regulatory timelines for the two drugs are part of the suit’s factual background. Bayer’s Nubeqa (NYSE:BAY) earned FDA approval for use as a doublet with ADT in June 2025. J&J’s Erleada (NYSE:JNJ) received approval for the same doublet indication in September 2019. Bayer reported global Nubeqa sales of 21.63 billion in the first nine months of 2025, which the complaint converts to approximately $1.81 billion using a September 30, 2025 conversion rate.
The core legal argument centers on whether J&J’s analysis satisfies the FDA standard that substantial evidence is required to support claims of superior efficacy between prescription products. Bayer says it does not.
According to the complaint, J&J based its advertised mortality advantage on a retrospective observational study that mined real-world data from electronic medical records and administrative claims. Bayer asserts this methodology falls short of the randomized controlled clinical trial standard that would be necessary to demonstrate one drugs superiority over another.
Bayer highlights aspects of the underlying dataset it says undermine comparability. The suit states that for 97% of the study period - from August 5, 2022 to June 30, 2025 - Nubeqa was being prescribed off-label as part of doublet therapy prior to its FDA approval on June 2, 2025. Bayer further alleges the analysis compared 1,460 patients treated with Erleada to just 287 patients who received Nubeqa.
The complaint contends that many of the smaller cohort of Nubeqa patients were treated off-label for specific clinical reasons that are not captured in the available electronic records and claims data. Bayer says that selection bias and the resulting non-comparability between the groups render J&Js mortality comparison invalid.
In its filing Bayer is seeking judicial relief to correct the marketing claims. The lawsuit frames the dispute as a question of whether a retrospective, observational, real-world analysis can support a direct superiority claim in promotional materials for prescription drugs.
Contextual note: The complaint sets out factual allegations and legal claims; the outcome will depend on judicial review of the underlying data and the parties legal arguments.