ANDA Sponsors Silent As Novartis Confirms US Gilenya Generic Entries
Ten Generics Manufacturers Hold FDA-Approved Fingolimod ANDAs
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.
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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.
Viatris’ Mylan and Teva are among firms holding approved ANDAs for generic Aubagio, as the product falls to generic competition in the US.
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.