Gilenya Generics May Be Imminent Amid US Federal Circuit Snub

HEC May Face US Supreme Court Date As Novartis Loses Again

21 Sep 2022

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.

US-Supreme-Court_V1_1200 — Novartis intends to take its fight to the Supreme Court • Source: Shutterstock

Generic versions of Novartis’ Gilenya (fingolimod) blockbuster treatment for multiple sclerosis, including lone litigator HEC Pharm’s ANDA product, may flood the US market imminently, following a favorable decision by the US Court of Appeals for the Federal Circuit.

Novartis’s concession came as HEC Pharm scored another legal victory over the Swiss originator in the firms’ long-running Gilenya patent-litigation...