Shire Receives VYVANSE Paragraph IV Notice Letters

Shire SHPGY announces that its subsidiary Shire LLC has received Paragraph IV Notice Letters from Amneal Pharmaceuticals and Watson Laboratories, advising of the filing of Abbreviated New Drug Applications by each company for generic version of all strengths of lisdexamfetamine dimesylate capsules, VYVANSE. These are the second and third Paragraph IV Notice Letters directed to VYVANSE received by Shire. The first Paragraph IV Notice Letter for Vyvanse was received by Shire on May 18, 2011 from Sandoz. VYVANSE is protected by sixteen FDA Orange Book listed patents, all of which expire in 2023. Shire is currently reviewing the details of Amneal's and Watson's Paragraph IV Notice Letters, which were directed to the patents listed in the Orange Book. Under the Hatch-Waxman Act, Shire has 45 days from the receipt of each of the Notice Letters to determine if it will file patent infringement suits against Amneal and Watson. If Shire brings suit pursuant to the Hatch-Waxman regulations, a 30-month stay of approval will be imposed by the FDA on Amneal's and Watson's ANDA.