Pharmalot: WSJBy Ed Silverman04/29/2015
Otsuka Pharmaceuticals was dealt a setback yesterday when the FDA approved four generic versions of its best-selling Abilify® antipsychotic pill, following an unusual and protracted legal battle. Shortly thereafter, Teva Pharmaceuticals announced that it was launching a copycat medicine. The move comes after Otsuka cited complex regulatory law to thwart generics, but the agency rejected the argument and decided that generic versions meet the standard for approval… And Otsuka also has a great deal at stake – Abilify® generated $4.9 billion in U.S. sales last year.
As we wrote previously, the FDA late last year approved Abilify® for treating children with Tourette syndrome, a neurological disorder that causes tics. Since Abilify® had a so-called orphan designation, which refers to a drug used to treat a rare malady like Tourette’s, Otsuka won another seven years of exclusive marketing rights – through late 2021 – before low-cost generics could appear.
But in February, the FDA surprised Otsuka by approving Abilify® to treat adults with Tourette syndrome. This widened the market, but Otsuka contends FDA law would trigger a labeling change that could usher in generics. Otsuka filed a lawsuit claiming the FDA isn’t allowed to approve an indication for which a drug maker didn’t apply and charged the agency was actually attempting to usher in generic copies.For its part, the FDA backpedaled and earlier this month told Otsuka that Abilify® was now approved to treat Tourette syndrome, but only for children. However, the agency also indicated it may use a so-called carve-out approach to approve generics for treating psychiatric disorders, but not Tourette syndrome. And that is what the FDA did Tuesday…