Otsuka v. U.S. Food and Drug Administration, Re Expanded Indication For Abilify

On April 15, 2015, the pharmaceutical company Otsuka sued the United States Food and Drug Administration (FDA) for its unsought decision in February 2015 to expand an age-specific orphan drug treatment indication for Otsuka’s atypical antipsychotic Abilify to all age groups, negating the patent protection of orphan drug exclusivity. In December 2014, the FDA had approved Otsuka’s application to market Abilify as a treatment for children diagnosed with Tourette syndrome. In February 2015, the FDA broadened the earlier approval to include adults with Tourette syndrome, although Otsuka had not applied to market the medication for this indication . . .