- Kapvay (clonidine) is a non-stimulant treatment for ADHD in pediatric patients aged 6 to 17.
- According to Federal Trade Commission (FTC) allegations, Concordia agreed not to sell a generic version of Kapvay in exchange for a share of Par's revenues. The firms have now settled the charges with the FTC.
- Concordia Pharmaceuticals was the brand manufacturer of Kapvay before patent expiry in 2013. After that, Concorida and Par Pharmaceuticals were the only two firms permitted by the FDA to sell generic Kapvay.
The FTC has been aggressively policing pay-to-delay activity since the Supreme Court decision in FTC v. Actavis in 2013. In fact, the FTC estimates that pay-to-delay deals cost American consumers roughly $3.5 billion. And while the Generic Pharmaceutical Association has pointed out that patent settlements between brand manufacturers and generics companies are not illegal, anticompetitive behavior is.
In this case, Concordia agreed not to sell generic Kapvay, based on an agreement sold in September 2013, shortly after the patent had expired. As part of this deal, which lasted roughly 14 months before the FTC shut it down, Concordia received roughly 35% to 50% of the profits.
"By agreeing not to compete," reads the FTC's complaint, "Concordia and Par… reduced the number of competing generic Kapvay products available to consumers. The agreement, therefore, deprived consumers of the lower prices that occur with generic competition."
Now both companies will be selling generic Kapvay, and have settled with the FTC.