Drug Safety Patent Fight: Avadel Sues US FDA Over Interpretation Of Xyrem REMS Patent Use Code
Executive Summary
Avadel challenges FDA requirement that it submit patent certification, asks court to direct the agency to issue final approval of its narcolepsy drug Lymryz. Having often criticized the use of REMS to delay competition, FDA now finds itself defending an Orange Book listing.
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Delisting Of Jazz’s Xyrem Patent In Orange Book Could Spur More Infringement Counterclaims
Jazz’s REMS patent on distribution of Xyrem does not belong in the Orange Book because it is directed to systems rather than a method of using the drug, court rules, agreeing with FTC’s analysis.
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