Shire LLC has received Paragraph IV notice letters from Amneal Pharmaceuticals, LLC and Watson Laboratories, Inc. advising of the filing of Abbreviated New Drug Applications (ANDA) 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 Vynanse 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.
The Hatch-Waxman exclusivity period for VYVANSE runs until February 23, 2012.
Shire expects to receive additional Paragraph IV certifications filed against Vyvanse on terms similar to those already received. Shire will provide details of any further Paragraph IV certifications received, and any litigation that is subsequently initiated, in its periodic filings on Forms 10-Q and 10-K.
Release Date: May 25, 2011
Filed Under: Drug Discovery