In Jazz Case, FTC Urges Court To Delist Patent on Blockbuster Xyrem .

 

As Jazz Pharmaceuticals Works To Hold Off Forthcoming Competition to its Top-Selling Drug, Antitrust Regulators in The U.S. Government Are Calling Out Its Tactics .

Fierce Pharma . By Eric Sagonowsky , Nov 14, 2022 .

In a Court Filing (PDF), the U.S. Federal Trade Commission (FTC) took issue with a Jazz Patent that covers a system for distributing Jazz's twice-nightly narcolepsy drug Xyrem under an FDA-required program to curb treatment-related risks .

Specifically, the agency says the company's patent doesn't qualify for listing in the FDA's Orange Book. Once a patent is listed in the book, the FDA can't approve potential rivals for 30 months, the FTC notes.

The patent details a Risk Evaluation and Mitigation Strategy program for distributing Jazz's drug, not a "a method of using the drug for treatment," the FTC says. The agency argues the patent should be delisted from the Orange Book, which would allow the FDA to give its final endorsment to a once-nightly rival from Avadel Pharmaceuticals.

Avadel won a tentative FDA approval for its extended-release rival to Jazz's narcolepsy drug Xyrem over the summer. The company is gearing up to launch the product, called Lumryz, by June 2023. But it could launch sooner if it prevails in its legal clash with Jazz . ...