Shire LLC, a subsidiary of Shire plc., has settled its litigation against Teva Pharmaceuticals USA Inc. in connection with Teva’s Abbreviated New Drug Application (ANDA) for a generic version of Shire’s Intuniv (guanfacince) extended release tablets for the treatment of Attention Deficit Hyperactivity Disorder.
The settlement provides Teva with a license to market in the United States either its own generic versions of Intuniv or authorized generic versions of Intuniv supplied by Shire. The license takes effect after the expiration of the 180 day exclusivity period granted to Actavis, as the first ANDA filer. Actavis is licensed by Shire to market generic product beginning on December 1, 2014.
The litigation involves a patent infringement lawsuit relating to US patents 6,287,599 (599 Patent), and 6,811,794 (794 Patent). A bench trial against Actavis and Teva was held in September 2012. As Shire has previously settled with Actavis, and has now settled with Teva, the court will not be issuing a decision on the trial. As part of the settlement, Teva has confirmed that its proposed generic products infringe Shire’s ’599 and ’794 Patents and that the two patents are valid and enforceable with respect to those proposed generic products.
The agreements, which are effective immediately, have been submitted to the US Federal Trade Commission for its review as required by law.