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www.fdanews.com/articles/67802-european-ruling-blow-to-gsk-on-generic-antidepressant

EUROPEAN RULING BLOW TO GSK ON GENERIC ANTIDEPRESSANT

January 21, 2005

European Union (EU) judicial authorities have issued a decision allowing generic drugmakers to market cheap versions of UK drug major GlaxoSmithKline (GSK)'s Paxil depression therapy. The ruling confirmed earlier advice issued in September.

Glaxo had maintained that the generics producers had simply modified the active principle of the drug, known as Seroxat in the UK, in order to claim novelty. However, the judgment claimed that the generic versions fulfilled novelty criteria, adding that GSK would have benefited from arguing its case on the basis of the drug's therapeutic action.

The case centred on Danish drugmakers Synthon BV and Genthon BV, which were granted licences by local health authorities. GSK subsequently sued the authorities, and is unlikely to believe that the judgment marks the end of the dispute. GSK has already warned that increasing generic competition on its Wellbutrin and Paxil antidepressants in the US is likely to impact profitability.