Shire model to defend Adderall exclusivityShire has written to the FDA demanding that makers of drugs rivaling its attention deficit hyperactivity disorder (ADHD) treatment for children, Adderall, conduct lengthy clinical trials to prove their drugs have the same effect.
According to published reports, analysts are uncertain the FDA will order the trials, but they suspect that its deliberations could delay approval for rival drugs beyond fall 2006, when generic versions of Adderall are expected on the market.
Shire said in a petition to the FDA that rival Barr Laboratories and others should have to prove their drug versions are metabolized by children in exactly the same way and over the same number of hours.
A similar petition by Johnson & Johnson on its ADHD drug Concerta has delayed approval of generic versions for more than a year.
Other efforts to extend exclusivity of Adderall include suing Barr for patent infringement in a U.S. case that is set to begin in January.