May 31, 2013
Shire LLC has settled its litigation against Teva Pharmaceuticals
Inc. ("Teva") 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 U.S. patents 6,287,599 ("the '599 Patent"), and 6,811,794 ("the '794 Patent"). A bench trial against Actavis and Teva was held in
. 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.
NOTES TO EDITORS
Shire enables people with life-altering conditions to lead better lives.
Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs.
We provide treatments in Neuroscience, Rare Diseases, Gastrointestinal, Internal Medicine and Regenerative Medicine and we are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas.