ANDA Sponsors Silent As Novartis Confirms US Gilenya Generic Entries
Ten Generics Manufacturers Hold FDA-Approved Fingolimod ANDAs
Executive Summary
One of the largest small molecule opportunities in the US, Novartis’s Gilenya to treat relapsing-remitting multiple sclerosis, now has generic competition, the originator has confirmed following a series of favorable court rulings for ANDA sponsors.
You may also be interested in...
‘Imminent’ Gilenya ANDA Launches Halted By US Supreme Court
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.
US Federal Circuit Will Not Stand In Way Of Gilenya Generics
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.
Viatris Eyes Gilenya Generic Following ‘Unreliable’ Study Data
Viatris has bounced back from withdrawing its application for a generic version of Gilenya in the EU with a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use.