Exelixis Settles CABOMETYX® Patent Dispute with Cipla

Exelixis, Inc. (Nasdaq: EXEL), an oncology company based in Alameda, California, has recently finalized a Settlement and License Agreement with Cipla Ltd. and Cipla USA, Inc. This agreement resolves two legal disputes initiated by Exelixis in response to Cipla's attempt to gain approval for generic versions of CABOMETYX® (cabozantinib) tablets before the expiry of the relevant patents.

The first lawsuit, filed in March 2023, was related to Cipla’s Abbreviated New Drug Application (ANDA) for a 60 mg dosage of cabozantinib. The second lawsuit, filed in May 2024, addressed a recent amendment to Cipla’s ANDA, which sought additional approvals for 20 mg and 40 mg dosages of cabozantinib.

Under the terms of the agreement, Exelixis will permit Cipla to market generic versions of CABOMETYX in the United States starting January 1, 2031, contingent upon approval from the U.S. Food and Drug Administration (FDA). This permission is subject to common conditions and exceptions typical of agreements of this nature.

Moreover, as part of the settlement, both parties have decided to cease all ongoing Hatch-Waxman litigation concerning CABOMETYX patents in the U.S. District Court for the District of Delaware. The agreement itself remains confidential and is pending review by the U.S. Federal Trade Commission (FTC) and the U.S. Department of Justice. Following this review period, the lawsuits are expected to be dismissed.

Exelixis is a prominent oncology-focused company known for pioneering next-generation cancer treatments. The company prides itself on its robust drug discovery and development capabilities, which have allowed it to build a comprehensive portfolio targeting a wide range of tumor types. Exelixis’s flagship product, CABOMETYX® (cabozantinib), is a testament to its commitment to developing clinically differentiated therapies. The company is dedicated to creating transformative treatments that offer hope and improved outcomes for cancer patients worldwide.

This settlement marks a significant step for Exelixis as it continues to protect its intellectual property while expanding access to its novel therapies. The resolution of these patent litigations not only secures the company's market position but also sets a clear timeline for the introduction of generic versions, ensuring continued innovation and patient access to life-saving treatments.

Exelixis’s approach combines decades of scientific research with strategic partnerships to advance its investigational programs. The company remains steadfast in its mission to revolutionize cancer care and improve patient survival rates. By 2031, if the generics are approved by the FDA, patients will have more affordable options for cabozantinib, potentially increasing the accessibility of this important medication.

In summary, the Settlement and License Agreement between Exelixis and Cipla signifies a crucial development in the pharmaceutical landscape, balancing the protection of innovative drug patents with the introduction of affordable generic alternatives. This agreement underscores Exelixis's ongoing dedication to advancing cancer treatments and providing hope to patients across the globe.