Judge rules against the sale of Gilenya generics amidst Novartis’ patent trial

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/Robert Daly)
(Image: Getty/Robert Daly)

Related tags: Novartis, Gilenya, Multiple sclerosis, Patent, court

US Federal court judge rules for Novartis to keep exclusivity of blockbuster MS drug until patent issues are settled.

The court ruled in favor of the Swiss drug-maker, Novartis, to keep exclusivity of its top-selling multiple sclerosis (MS) medicine Gilenya (fingolimod) in the US. The company had requested a preliminary injection to stop Dr. Reddy’s Laboratories, Mylan Pharmaceuticals, Torrent Pharma, and Aurobindo Pharma from producing or selling generic versions of the drug.

Novartis will be the only company to sell any version of Gilenya until a final decision on Novartis’ patent​ for the medicine is made.

A patent extension of Gilenya expires in 2019 and Novartis is currently in trial to establish a patent on the dosing of the drug that would then expire in 2027.

US District Judge Leonard Stark wrote in his published opinion​ that the sales of generic versions prior to the final patent decision would cause more damage to Novartis than it would to those seeking to introduce generic versions of the drug onto the market.

Stark explained that generic drug makers would lose around $50m (€43.97m) collectively by not producing or selling this drug in the next year, but Novartis will lose a US market for the drug which brings in $1.8bn a year.

In 2018 revenue for Gilenya totaled $3.3bn worldwide, making it Novartis’ top-selling medicine. The drug has a list price of $99,595 annually in the US.

Related topics: Regulatory & Safety, Regulations

Related news

Show more

Related suppliers