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 Pharmaceuticals Group has filed a second complaint against Impax Laboratories in the ongoing dispute over generic versions of Shire's ADHD drug Adderall XR.
Subscribe to our email newsletter
Shire previously announced a pending suit against Impax based on Impax’s notice letter for a 30mg generic version of Adderall XR. Shire has now filed a second complaint based on an additional notice letter from Impax advising of the filing of an abbreviated new drug application (ANDA) for a generic version of the 5mg, 10mg, 15mg, 20mg and 25mg strengths of the mixed amphetamine product.
Shire has also received notice letters regarding generic versions of all strengths of Adderall XR from Barr Laboratories and from Colony Pharmaceuticals. Shire has filed lawsuits against Barr, the first company to send a notice letter, but has chosen not to sue Colony.
Barr, Impax and Colony may not launch a generic version of Adderall XR before receiving final approval of their respective ANDAs from the FDA. Should Barr receive a tentative approval from the FDA, it cannot lawfully launch its generic version before either the expiration of the currently pending 30-month stays or a district court decision in its favor.
Neither Impax nor Colony will be able to lawfully launch a generic version of Adderall XR without the necessary final approval from the FDA and the expiration of the “first to file’s” exclusivity rights. The FDA may grant 180 days of generic market exclusivity to the “first to file”.
The Barr court case is scheduled to go to trial in January 2006 while the Impax case has an October 2005 trial date.
Adderall XR is a key product in Shire’s portfolio of treatments for ADHD and is protected by two patents, which expire in 2018.