Sandoz files for generic of Shire's Vyvanse; FDA warning

Ireland-headquartered biopharmaceutical company Shire (LSE: SHP) yesterday revealed that its US subsidiary has received a Paragraph IV Notice Letter from Sandoz, the generics unit of Swiss drug major Novartis (NOVN: VX) advising of the filing of an Abbreviated New Drug Application for a generic version of all strengths of its attention-deficit hyperactivity disorder (ADHA) treatment Vyvanse (lisdexamfetamine dimesylate) , thus challenging the patents on the drug.

This is the first Paragraph IV Notice Letter directed to Vyvanse received by Shire, which says the drug is protected by 16 Food and Drug Administration Orange Book listed patents, all of which expire in 2023. Although there is little near-term threat, as legal action could take as long as 40 months, Shire’s share yesterday closed down 1.4% at £19.22, cancelling out some of the gains made the day before when the drugmaker announced it was buying the regenerative medicines firm Advanced BioHealing for $750 million (The Pharma Letter May 18).

Shire is currently reviewing the details of Sandoz's 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.