FTC Settles with Par, Concordia Over Sale of ADHD Drug

The Federal Trade Commission has reached a settlement with Par Pharmaceuticals and Concordia Pharmaceuticals that, if finalized, would prohibit them from restraining trade in the sale of generic Kapvay, an attention deficit hyperactivity disorder drug.

Until May 15, Par and Concordia were the only two companies with FDA approval to market generic Kapvay. The FTC claims the drugmakers entered into an illegal agreement not to compete in selling the generic version of Kapvay (clonidine), resulting in higher prices.

Specifically, the FTC says that rather than competing against one another, Concordia agreed not to sell an authorized generic version of Kapvay in exchange for 35 percent to 50 percent of Par’s revenues.

The settlement would prohibit the companies from agreeing with other drugmakers to bar or delay entry of an authorized generic after the brandname drug’s patents have expired. It would also require them to provide notice to the FTC of any patent settlement that restricts entry of an authorized generic and to establish compliance programs to prevent future abuses.

The FTC will decide whether to finalize the proposed consent order after considering public input. Comments are due by Sept. 17.

Concordia’s spokeswoman Marija Mandic said that the settlement doesn’t constitute an admission of wrongdoing. Par did not respond to a request for comment by press time. — Jonathon Shacat