While Novartis combats generic onslaught in the courts, FDA approves first Gilenya copycats
While Novartis is battling to weaken the challengers vying to market copycat versions of its blockbuster multiple sclerosis treatment Gilenya — the US drug regulator on Thursday approved a trifecta of the drug’s first knockoffs. When they will launch is another question altogether.
Known chemically as fingolimod, Gilenya was approved by the FDA in 2010 for relapsing-remitting multiple sclerosis. It generated sales of about $2.4 billion in sales in the first nine months of this year.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.