Xyrem (sodium oxybate) Xyrem is approved to treat narcolepsy and generates more than $1 billion in yearly US sales for Jazz Pharmaceuticals. To delay generic competition (and cheaper prices), Jazz filed baseless patent infringement litigation against several manufacturers who applied to market generic versions of Xyrem. In April, 2017, when Roxane was poised to launch its generic version, Jazz made an unlawful reverse payment deal with Roxane to delay generic competition until at least 2023. Jazz also filed baseless “citizen petitions” asking the FDA to refrain from approving generic versions of Xyrem, and Jazz abused the FDA’s Risk Evaluation and Mitigation Strategies (“REMS”) program, which caused further delay. Absent Jazz’s unlawful conduct, generic competition for Xyrem would have appeared as early as January 2018.
This article was originally published under the firm’s former name, Spector Roseman & Kodroff, P.C. (“SRK”). The firm is now known as Spector Caldes & Corrigan, PC (“SCC”).
