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Injunction Junction, What’s Your Function under the Patent Safe Harbor?

Summary by FDA Law Blog
By Sara W. Koblitz —In yet another installment of the drama that is Jazz v. Avadel, the Federal Circuit recently reviewed a decision from the U.S. District Court for the District of Delaware that addressed the scope of an injunction under the patent safe harbor imposed on Avadel’s Lumryz (sodium oxybate).   Specifically, the District Court enjoined Avadel from (1) offering open-label extensions to clinical trial participants, (2) applying for FD…
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FDA Law Blog broke the news in on Thursday, May 29, 2025.
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