Victory Swings Back To Gilenya Generics With Latest US Supreme Court Order
Topsy-Turvy Case Saw ‘Imminent’ Gilenya ANDA Launches Halted By Supreme Court
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.
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Justice Kavanaugh voted to grant Teva’s petition for certiorari. It is unknown if other justices voted with him. The high court last month declined to hear Novartis's Gilenya patent case and Sanofi’s antitrust allegations against Mylan’s EpiPen rebate agreements.
Novartis has been rejected in its attempt to convince the US Supreme Court to review litigation over Gilenya, the outcome of which has seen generic versions of fingolimod hit the market.
In a dramatic twist, Gilenya ANDA sponsors are now unable to launch their generic products in the US after the US Supreme Court intervened in favor of originator Novartis, superseding the US Federal Circuit.