DUBLIN — Sandoz is looking to market a generic version of a Shire drug for treating attention deficit hyperactivity disorder.
Shire said Thursday that it received a notice letter from Sandoz, the generics division of Swiss drug maker Novartis, that the latter had filed a regulatory approval application with the Food and Drug Administration for a generic version of Vyvanse (lisdexamfetamine dimesylate). The application contained a Paragraph IV certification, a legal assertion that the patents covering Vyvanse — all of which expire in 2023, according to the FDA Orange Book — are invalid, unenforceable or won’t be infringed.
Under the Hatch-Waxman Act of 1984, Shire has 45 days in which to review Sandoz’s letter and determine if it will file a patent infringement suit, which would result in the FDA placing a 30-month stay of approval on the generic. In many cases of generic drug companies challenging branded drug patents, however, the generic and branded company will reach a settlement that allows the generic launch to occur before the patents expire.