Shire plc, the global specialty biopharmaceutical company, announces that its subsidiary Shire LLC has received a Paragraph IV Notice Letter from Sandoz Inc. (Sandoz) advising of the filing of an Abbreviated New Drug Application (ANDA) for a generic version of all strengths of lisdexamfetamine dimesylate capsules, Vyvanse. This is the first Paragraph IV Notice Letter directed to Vyvanse received by the company.
Vyvanse is protected by sixteen FDA Orange Book listed patents, all of which expire in 2023.
Shire is currently reviewing the details of Sandoz’s Paragraph IV Notice Letter, which was directed to all of the patents listed in the Orange Book.
Under the Hatch-Waxman Act, Shire has 45 days from the receipt of the Notice Letter to determine if it will file a patent infringement suit. If Shire brings suit pursuant to the Hatch-Waxman regulations, a 30-month stay of approval will be imposed by the FDA on Sandoz’s ANDA.
The Hatch-Waxman exclusivity period for Vyvanse runs until February 23, 2012.
Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions.