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

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.

Injunction
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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