September 6, 2012
Shire plc (LSE: SHP, NASDAQ: SHPG), announces that its subsidiary, Shire LLC, has settled all pending litigation with Anchen Pharmaceuticals, Inc., and Anchen, Inc.("Anchen") and TWi Pharmaceuticals, Inc. ("TWi") in connection with TWi's Abbreviated New Drug Application ("ANDA") for a generic version of Shire's INTUNIV
( guanfacine hydrochloride) for the treatment of Attention Deficit Hyperactivity Disorder. Anchen is TWi's authorized distributor and its filing agent with the US Food and Drug Administration.
The settlement provides TWi with a license to make, and Anchen a license to market, TWi's generic versions of INTUNIV in
the United States
July 1, 2016
, or earlier in certain limited circumstances. Such sales will require the payment of a royalty to Shire, except in certain circumstances. Also as part of the settlement, under certain circumstances Shire may authorize Anchen to sell authorized generic versions of INTUNIV supplied by Shire, on which Shire will receive a significant royalty. To date, the US Food and Drug Administration has not granted final approval for any generic version of INTUNIV.
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"). As part of the settlement, Anchen and TWi have agreed to a consent judgment confirming that their 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 and any other generic version of INTUNIV.
Shire's litigation with Teva Pharmaceuticals
, Inc and Actavis Inc. in the US District Court in
in connection with their ANDAs, and attempt to market generic versions of Shire's INTUNIV, is not affected by this settlement. The lawsuits against those parties asserting infringement of Shire's '599 and '794 Patents are ongoing and a trial is scheduled to begin on
September 17, 2012
The agreements, which are effective immediately, will be submitted to the US Federal Trade Commission and Department of Justice for review as required by law.