The U.S. Food and Drug Administration (FDA) has approved the first AB-rated generics to Lilly’s Strattera® (atomoxetine), a drug approved for the treatment of attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients. Generic exclusivity was not granted. Generics were approved from Apotex, Aurobindo, Glenmark and Teva.
Strattera is a non-stimulant drug originally approved by the FDA in 2002. The last patent for Strattera expired on May 26, 2017. As a result, the FDA was able to approve all eligible atomoxetine abbreviated new drug applications (ANDAs).
Shipments of the generics have already begun.