Shire settles with Sandoz over ADHD drug

PHILADELPHIA A British branded drug maker and one of the world’s largest generic drug makers have settled a lawsuit over the latter’s attempts to market a generic version of an attention deficit hyperactivity disorder drug.

Shire announced Tuesday that it had reached a settlement with Sandoz, the generics arm of Novartis, over the drug Adderall XR (mixed amphetamine salts). Sandoz had attempted to file an approval application with the Food and Drug Administration to market a generic version of the drug, prompting a patent infringement lawsuit from Shire.

Under the settlement, Shire gave Sandoz a license to market a generic version of the drug once it gets FDA approval, though Sandoz will pay Shire a royalty from sales. Impax Pharmaceuticals and Barr Labs – now a subsidiary of Teva – make authorized generic versions of Adderall XR, though no generic version has received FDA approval.