Novartis, which reportedly generates $3.8m per day in US Gilenya sales, is once again facing up to the prospect of imminent generic competition to its blockbuster treatment for relapsing-remitting multiple sclerosis, following the latest order by the US Supreme Court.

ANDA sponsors targeting Novartis’s Gilenya have been informed by the US Court of Appeals for the Federal Circuit that at an ‘at-risk’ launch is possible, after the originator’s latest petition to the court was denied as it seeks a ruling from the US Supreme Court.

Are US Gilenya generics set to flood the US market? HEC Pharm is hoping so, following a favorable Federal Circuit denial. However, in a bid to maintain its monopoly and avoid a potential $300m hit to its top line, Novartis is taking its fight to the US Supreme Court.

Novartis is sticking to its plan to continue fighting HEC Pharm in court, after it recently lost a key decision for its Gilenya (fingolimod) blockbuster treatment for multiple sclerosis.