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Home » Still targeting Xtandi, groups ask CMS to do what NIH wouldn’t
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Still targeting Xtandi, groups ask CMS to do what NIH wouldn’t

April 10, 2024
By Mari Serebrov
Having failed in their efforts to get the U.S. NIH to march in on Xtandi’s patents under the Bayh-Dole Act because of price, Knowledge Ecology International and two other advocacy groups are now asking the Centers for Medicare & Medicaid Services (CMS) to do what the NIH refused to do. But rather than pressing for a march-in, which can be a lengthy process, the groups are pushing for CMS to use other statutory tools to clear the way for Xtandi (enzalutamide) generics to launch in the U.S. before Astellas Pharma Inc.’s three remaining patents for the prostate cancer drug expire in 2026 and 2027.
BioWorld Regulatory Cancer Generic U.S. CMS NIH Patents

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