Bystolic (nebivolol HCL)AbbVie’s blood pressure drug, Bystolic, accountsfor nearly $1 billion in yearly US sales. In December2011, manufacturers began applying to market genericversions of Bystolic. AbbVie’s subsidiary, Forest, sued those manufacturers for patent infringement. Such lawsuits cause an automatic stay of FDA approvals, meaning a generic version of Bystolic could not be approved until at least June 2015. Between October 2012 and November 2013, AbbVie and Forest made unlawful reverse payment deals with at least 7 generic manufacturers to stay off the market. As a result, generic competition for Bystolic has been suppressed until 2021.
Xyrem (sodium oxybate)Xyrem is approved to treat narcolepsy and generates morethan $1 billion in yearly US sales for Jazz Pharmaceuticals.To delay generic competition (and cheaper prices), Jazzfiled 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.