Shire Laboratories sues Andrx Pharmaceuticals

Shire Laboratories, a subsidiary of Shire, has announced that is has filed a lawsuit against Andrx Pharmaceuticals and its parent, Andrx.

The lawsuit relate to an abbreviated new drug application by Andrx for 5-30mg generic versions of Adderall XR, with the application an alleged infringement on the US Patent Nos 6,322,819 and 6,605,300 (the 819 patent and 300 patent).

Adderall XR is an extended-release mixed amphetamine salt developed by Shire for the treatment of attention deficit hyperactivity disorder.

Andrx has given notice that it would aim to market its generic version of Adderall XR before the 819 and 300 patents are due to expire in 2018. Watson Pharmaceuticals, which recently acquired Andrx, has also been named in the legal proceedings.

“Pursuant to Hatch-Waxman legislation, there will be a 30-month stay with respect to Andrx’s generic products,” Shire reports.

In August, British-based Shire announced that it settled its expected litigation with Barr Laboratories relating to that company’s new drug application for the marketing of generic forms of Adderall XR.

The companies entered into a development and license agreement, with Barr being barred from marketing generic forms of Adderall XR in the US until April 2009, unless certain conditions change, such as the launch of a similar generic product by another pharmaceutical company.