FDA greenlights generics of Novartis' $3B MS star Gilenya amid legal fight

Novartis headquarters
Three newly approved Gilenya generics could eventually threaten Novartis' market share in multiple sclerosis. (Novartis)

In June, a U.S. district court judge temporarily shielded Novartis’ $3 billion-a-year multiple sclerosis (MS) drug Gilenya from generic competition—but that’s not preventing generics makers from lining up at the starting gate.

Thursday, the FDA approved the first three generic versions of Gilenya, which will be made by HEC Pharm, Biocon and Sun Pharmaceutical. They won't hit the market anytime soon due to the aforementioned ruling, but the approval starts the clock on a patent expiration Novartis investors have long been dreading.

Novartis turned to the U.S. courts to help it fight off generic competition to Gilenya in the summer of 2018, when the U.S. Patent Office issued a ruling that protected the branded version of the drug until 2027. The company filed four lawsuits in federal court to hold off generic launches.

U.S. District Judge Leonard P. Stark ruled in favor of Novartis in one of those cases, broadly stating that allowing generic launches would threaten the company’s ongoing patent cases in federal court. The timing of that litigation is uncertain—some analysts expect it won’t be resolved until the first half of next year at the earliest—so Stark ruled that Novartis should maintain its market exclusivity.

“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,” Stark wrote (PDF), “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.”

Novartis declined to comment in response to a query from FiercePharma.

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

The approval of Gilenya generics comes at a pivotal time in the MS market. Several new drugs to treat the neurological condition have premiered this year, including Merck’s Mavenclad, Biogen’s Vumerity and Novartis’ own Mayzent. Some analysts estimate that Mayzent could eventually hit blockbuster territory.

Novartis has certainly done its part to try to make Mayzent as popular among physicians as Gilenya has been. In May, the company rolled out data from a phase 3 study showing that Mayzent produces significant benefits in cognitive processing speed—the ability of patients to understand and respond to information. More recently, Novartis showed the new drug delays wheelchair use by four years when compared to placebo.

RELATED: Novartis, Merck KGaA and Biogen: Which new MS drug do doctors like best? You might be surprised

Still, the entry of Gilenya generics could be a threat to Mayzent and all of the other new MS products. In November, analysts at SVB Leerink polled five doctors who treat MS, and they all predicted future generics of “category pioneers” like Gilenya will be more popular in the market than newer entries.

The physicians SVB Leerink polled felt Mayzent was only slightly better than Gilenya based on the newer drug’s improved toxicity profile, but that might not be enough to justify premium pricing, the analysts concluded.

During Novartis’ third-quarter report, the company said Gilenya sales fell 3% in the first nine months of the year to $2.4 billion. The company still upped its expectations for the full year, forecasting that net sales in its innovative medicines unit would grow by the high single digits. But that’s assuming no Gilenya generics enter the market in 2019, the company said.

Suggested Articles

Pfizer isn't giving up in biosims. This week, it unveiled launches to three Roche blockbusters, with two already on the market.

Novo Nordisk is betting big on GLP-1 Saxenda in its global obesity push, but England's cost watchdog is unimpressed with the drug's long-term outlook.

Tecentriq didn’t show benefit against simple observation at delaying cancer recurrence or death in patients with muscle-invasive urothelial cancer.