Federal Circuit Upholds Shire’s Patents for ADHD Drug
A federal appeals court has affirmed Shire Pharmaceuticals’ patents for Vyvanse, blocking efforts by five drugmakers to market generic versions of the attention deficit hyperactivity disorder drug.
The Federal Circuit last week upheld a New Jersey federal judge’s June 2014 summary judgment against Amneal Pharmaceuticals, Roxane Laboratories, Sandoz, Mylan and Actavis — allowing Shire’s patents to remain in place until 2023.
Vyvanse is a blockbuster for Shire, bringing in $425 million during the second quarter of this year, about 27 percent of company revenues. The drugmaker has been involved in litigation since 2011 to keep generic Vyvanse from getting FDA approval.
In 2014, Shire agreed to pay the federal government $56.5 million to settle allegations it peddled outlandish superiority claims for Vyvanse and its other ADHD drugs. Among other things, the company claimed that Vyvanse could prevent traffic accidents, divorce, arrests and unemployment. — John Bechtel