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Shire Licenses Teva to Sell Genereic Version of INTUNIV treatment for ADHD

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/By Ilan Shavit/

Pharmaceutical company Shire LLC announced on May 31st it has settled its litigation against Israeli company Teva Pharmaceutical’s US subsidiary, Teva Pharmaceuticals USA Inc., (“Teva”) in connection with Teva’s Abbreviated New Drug Application for a generic version of Shire’s INTUNIV®,   extended release tablets of the chemical substance guanfacince, for the treatment of Attention Deficit Hyperactivity Disorder – known as ADHD or sometimes just as ADD.
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 will take effect after the expiration of a 180 day exclusivity period granted to another generic drug manufacturer Actavis, which was the first abbreviated new drug application filer for generic versions of INTUNIV.  Actavis is now licensed by Shire to market their generic product beginning onDecember 1, 2014.  
The litigation involved 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 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.

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