UK pharmaceuticals titan Shire has settled all pending litigation relating to TWi Pharmaceuticals' application to produce a generic version of Shire's INTUNIV treatment for attention deficit hyperactivity disorder (ADHD).
The settlement provides Taiwanese company TWi with a licence to make generic versions of INTUNIV in the United States from July 1st, 2016, or earlier in certain limited circumstances. US pharmaceuticals company Anchen has been granted a licence to sell TWi's generic versions of INTUNIV in the US.
Every US sales will generate a royalty payment to Shire, except in certain circumstances. Also as part of the settlement, under certain circumstances Shire may sanction Anchen to sell authorised generic versions of INTUNIV supplied by Shire, on which Shire will receive a significant royalty.
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As of yet, the US Food and Drug Administration has not granted final approval for any generic version of INTUNIV.
The agreement brings to an end the dispute between the three parties, and has resulted in Anchen and TWi agreeing 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.
The agreements still need to be ratified by the US Federal Trade Commission and Department of Justice, but the market was happy with the news, with Shire's shares rising 32p to 1,974p.
JH
