Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Shire has filed lawsuits against Amneal Pharmaceuticals and Novartis’ generic arm Sandoz for infringing certain VYVANSE patents in the US District Court for the District of New Jersey.
Subscribe to our email newsletter
VYVANSE is a prescription medicine for the treatment of attention deficit hyperactivity disorder (ADHD).
Efficacy was based on two controlled trials in children aged six to 12 and two controlled trials in adults.
Reportedly, Amneal and Sandoz filed abbreviated new drug applications (ANDAs) with FDA to market and sell generic versions of all currently approved doses of VYVANSE.
Under the Hatch-Waxman Act, the FDA must refrain from approving the Sandoz and Amneal ANDAs for 30 months (expiring 23 August 2014), or until a district court decision finding that the patents are invalid or not infringed, whichever occurs earlier.