Top US Generics Players Thwarted On August At-Risk Launch Of Fingolimod

 
• By Aidan Fry
  
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Difficulties around damages, fears over first-dose observations and criticism of invalidity challenges all contributed to a US district court judge issuing a preliminary injunction to stop leading generics players launching rivals to Novartis’ Gilenya fingolimod multiple sclerosis brand after the molecule patent expires in August this year.

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Leading US generics players have been hit by an injunction preventing launch of fingolimod pending trial over a dosage regimen patent • Source: Shutterstock

The prospect of “massive and immediate price erosion in the market for oral treatment of relapsing-remitting multiple sclerosis” if up to six generic fingolimods were launched at-risk in the US when a molecule patent protecting Novartis’ Gilenya expires in mid-August this year has persuaded a Delaware district judge to grant an preliminary injunction barring generic competition until a decision at trial.

Delaware District Judge Leonard Stark was not convinced by any of the three arguments brought by generics defendants including Accord...

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