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November 18, 2022

FTC Says Patents Improperly Included in “Orange Book” Block Drug Competition

In an amicus brief filed last week, the FTC requested that a Delaware federal district court remove a patent related to the narcolepsy drug Xyrem from the FDA’s “Orange Book.”

 The Orange Book lists approved prescription drugs, patent and exclusivity information, and evaluations of therapeutic equivalence. When a patent is listed in the Orange Book, a brand company can file an infringement suit against a competitor and block competition for up to two and a half years. In its amicus brief, the FTC argued that Jazz Pharmaceuticals’ patent for Xyrem was impermissibly listed in the Orange Book, and that its improper inclusion blocks other competing products that could improve quality and lower prices for consumers. Since Jazz acquired Xyrem in 2005, it has filed multiple patent suits related to the drug and has stalled competitors’ efforts to bring another narcolepsy product to market.

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