FDA approves first generics of Novartis blockbuster MS drug

Dec. 6, 2019

The U.S. FDA has approved three applications for first generics of Gilenya capsules for the treatment of relapsing forms of multiple sclerosis in adults.

The approval allows HEC Pharm Co., Biocon and Sun Pharmaceutical to produce the drug.

Nearly a decade after its U.S. approval, Gilenya remains Novartis’ No. 2 revenue generator at $829 million in the third quarter. The drugmaker had been fending off generic rivals in the courts. It recently extended its exclusivity period to 2027 by asserting that a patent on how the drug is dosed.

The newly approved Gilenya generics will mostly like not be available in the the United States until 2021.

Read the FDA press release