Novartis' Gilenya staves off generic challengers⁠—for now⁠—after federal injunction

Novartis’ multiple sclerosis med Gilenya is facing U.S. generic challengers on all sides to its blockbuster sales, and the company hoped a court order could stave them off. The Swiss drugmaker got what it asked for—and it might just keep the med at the top of Novartis’ bestseller list, at least for now.

A suite of Gilenya competitors, including Mylan, Dr. Reddy’s Laboratories and Aurobindo Pharma, have been barred from immediately launching generic versions of the drug after a U.S. district judge in Delaware issued a temporary injunction Monday at Novartis’ request. The judge, Leonard P. Stark, said allowing the generics to launch would compromise Gilenya’s ongoing patent litigation in federal court and potentially cost Novartis its $1.71 billion U.S. market share before a decision is reached.

"After what might be as long as a year of generic competition by the time we get to trial and I get a post-trial opinion done, Novartis will not be able to raise the price back to where it is now, or to where it would have been at that post-trial date in the absence of defendants’ at-risk infringement," Stark wrote.

The temporary injunction puts a hold on the doomsday clock for Gilenya, which was first approved to treat relapsing-remitting multiple sclerosis (RRMS) in 2010. Gilenya is competing with a growing pack of branded RRMS competitors, including Roche’s hot shot Ocrevus and Merck KGaA’s Mavenclad, which analysts have pegged as a potential blockbuster, among others.

Novartis' crusade against Gilenya generic challengers began in July 2018 after a U.S. Patent Office decision backed the drug’s patent protection until 2027. The drugmaker filed four lawsuits in federal court to put off generic launches, including the one Stark ruled on Monday, Novartis Pharmaceuticals Corporation v. Accord Healthcare, et al.

The initial patent decision was not only a win for Novartis, but also for Celgene, which was rushing its own MS candidate ozanimod to market to get ahead of the generic wave, and Biogen, which competes in the same indications as Gilenya.

In the meantime, Novartis can rest easy knowing Gilenya grew 4.4% on the year in 2018 and recently added another notch to its belt in October after besting Teva’s Copaxone in a head-to-head study in preventing patient relapses. That win was nothing to shrug at: Gilenya became the first disease-modifying MS drug to top Copaxone in preventing relapses.

That data will also help Novartis stay ahead of its competitors, including newcomer Mavenclad, a drug that's showing promise despite a black box warning for an increased risk of cancer and birth defects. After failing to get an FDA nod all the way back in 2011, Mavenclad received its RRMS approval in April with blockbuster sales forecasts already teed up. Bernstein analyst Wimal Kapadia, for one, predicted the drug could hit $1 billion in global sales by 2025.

Novartis isn't pinning all its MS sales hopes on Gilenya, though. It recently scored an approval for Mayzent, a drug specifically approved for the secondary progressive form of the disease and one analyst predicts will hit blockbuster heights.