#United States #CARY #CINVANTI #Heron Therapeutics #Mylan Pharmaceuticals

Heron Therapeutics and Mylan Settle Patent Disputes

On May 6, 2025, Heron Therapeutics, Inc. announced a significant settlement with Mylan Pharmaceuticals, a subsidiary of Viatris Inc., concerning the ongoing patent litigations for their flagship products, CINVANTI® and APONVIE®. These injectable emulsions, primarily used for preventing chemotherapy-induced nausea and vomiting (CINV), have been at the heart of legal battles since late 2023.

The settlement allows Mylan to obtain a license under Heron’s Orange Book-listed patents, which will enable it to market generic versions of CINVANTI® and APONVIE® in the United States starting June 1, 2032, or in certain standard circumstances potentially earlier. This resolution is part of a comprehensive strategy by Heron to safeguard its intellectual property while also navigating the competitive landscape of the pharmaceutical market.

In late 2023 and early 2024, Heron initiated patent litigations after Mylan submitted abbreviated new drug applications, seeking FDA approval for generic counterparts to its products before the expiration of Heron’s patents in 2035. Heron’s legal team argued that Mylan's attempts to enter the market prematurely would infringe upon its intellectual innovation and compromise patient access to high-quality medications developed through significant research investment.

As a result of the recent settlement, both companies intend to file a proposed Stipulation and Order of Dismissal with the U.S. District Court for the District of Delaware, effectively concluding the current legal proceedings between them. This closure not only clears the way for Mylan’s entry into the market but also reaffirms Heron’s commitment to advancing its oncology-focused portfolio without the distraction of contentious litigation.

Heron Therapeutics, positioned as a commercial-stage biotechnology firm, has dedicated itself to enhancing patients' lives through innovative therapeutic solutions. With a focus on patent-protected drugs that aim to elevate standards of care in acute medicine and oncology, the company has crafted a diverse portfolio of therapeutic options that include CINVANTI® and APONVIE®. Heron’s emphasis on advanced science and innovation is evident in its approach to drug discovery and delivery.

Moving forward, the partnership with Mylan may offer new opportunities for collaboration in addressing unmet medical needs in oncology care, while ensuring that patients have access to cost-effective medication alternatives. Market dynamics will inevitably evolve with Mylan’s introduction of generics, prompting discussions on pricing, patient access, and health outcomes associated with the transition from branded to generic products.

Heron Therapeutics acknowledges the risks involved in the pharmaceutical sector, which it openly addresses in its communications to stakeholders. The company provides transparency regarding potential uncertainties that could impact performance, as it continues to develop and commercialize therapeutic innovations responsive to real-world healthcare challenges.

For further insights about Heron Therapeutics and its settlement with Mylan, visit their official platform at www.herontx.com. Investors and stakeholders should remain informed of the developments that may arise as both companies implement this settlement agreement and adapt to a new competitive landscape in the pharmaceutical industry.

In conclusion, this settlement marks a strategic pivot for Heron Therapeutics as it seeks to balance innovation with market realities in a complex healthcare environment. As Mylan prepares to launch its generics, both entities will likely engage in a dialogue aimed at improving patient care through affordable treatment options.