Drug Safety Patent Fight: Avadel Sues US FDA Over Interpretation Of Xyrem REMS Patent Use Code

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.

Narcolepsy
Avadel sues FDA over patent decision that will delay approval of its narcolepsy treatment • Source: Shutterstock

Avadel Pharmaceuticals plc contends the US Food and Drug Administration wrongly required it to submit a patent certification to the patent covering Jazz Pharmaceuticals plc’s Xyrem Risk Evaluation and Mitigation Strategy, which will delay final approval of its competing sodium oxybate narcolepsy drug Lumryz.

In a 21 July complaint against the FDA, Avadel says the agency concluded that it must submit patent certification...

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