Shire said that the lawsuit results from abbreviated new drug applications (ANDAs) filed by Impax and Watson for generic versions of 4mg guanfacine hydrochloride extended release tablets, INTUNIV, which seek to market such generic products before the expiration of the ‘290, ‘599, and ‘794 patents.
The regulatory exclusivity period for INTUNIV runs through 2 September 2012.
Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions.
Shire’s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights.