Generic version of ADHD drug reaches market early

April 7, 2009

Teva is now selling generic versions of Shire Plc's ADHD drug Adderall XR in the US, years before its patent expires.

Teva has started selling generic versions of Shire plc's Adderall XR drug (mixed amphetamine salts) in the U.S. years prior to the patent expiration, due to a licensing settlement.

In 2006, Shire of Ireland and Barr Pharmaceuticals, now a Teva-owned entity, co-signed a licensing agreement. The agreement opened the door to commercial shipment of generic forms of the drug used for attention deficit hyperactivity disorder prior to the patent's expiration to settle patent litigation over the drug that dates to 2003.

Specifically, the agreement enabled Barr to launch (via Teva, in this case) generic capsules in forms ranging from 5- to 30-mg doses with exclusivity for 180 days, effective April 1, 2009. This settlement allows generics to be sold a full nine years prior to the drug's patent expiration in 2018.