The second letter of notice sent to Shire by Teva advises of an amendment to Teva’s existing application for generic versions of Adderall XR. The amendment is directed to additional strengths of 5mg, 15mg, and 20mg dosages. Teva’s previous letter was directed only to 10mg and 30mg dosages.
Barr Laboratories, Impax Laboratories, and Colony Pharmaceuticals have also sought to market generic versions of the Shire drug. Shire has filed lawsuits against Barr and Impax and is currently reviewing Teva’s new application. Shire previously chose not to sue Teva for the application directed to the 10mg and 30mg dosages.
While the Barr court case is scheduled to go to trial in January 2006, the Impax case has been consolidated and is scheduled to go to trial in February 2006.
Adderall XR is an important product in Shire’s portfolio of treatments for ADHD and is said to be protected by two patents which expire in 2018.