Exelixis (EXEL) said Monday that the US Court of Appeals for the Federal Circuit has affirmed a key portion of the 2024 judgment of the US District Court for the District of Delaware in its favor in the lawsuit Exelixis vs. MSN Laboratories.
The Federal Circuit's decision upheld the validity of three patents covering the crystalline malate salt of cabozantinib, preserving market exclusivity for Exelixis' cabozantinib, and dismissed the appeal regarding the validity dispute over another Exelixis patent covering low-impurity cabozantinib formulations, ruling the matter moot.
Given the decision, the earliest that MSN may be permitted to commercially launch its proposed generic product in the US is Jan. 15, 2030, subject to any additional appeals or regulatory exclusivity, the company added.
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