Actavis has received approval from the United States Food & Drug Administration (FDA) to market Atomoxetine HCl capsules for the treatment of ADHD (attention deficit / hyperactivity disorder).
No release date has been set for Atomoxetine, Actavis’ generic equivalent to Eli Lilly and Company’s Strattera®. The US Court of Appeals for the Federal Circuit is reviewing a ruling from 12 August that invalidated Lilly’s patent, which is due to expire in 2017.
Actavis intends to market Atomoxetine HCl in 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg strengths.
According to IMS Health data, US sales of Strattera® were USD532 million for the 12-month period ended June 2010.