FDA Approves First Gilenya Generics

December 17, 2019

Novartis’ blockbuster multiple sclerosis drug Gilenya (fingolimod) may soon face generic competitors in the U.S., following three FDA approvals.

Biocon, HEC Pharm and Sun Pharmaceutical all received the agency’s approval for their generic versions of the immunosuppressive drug, which is intended to treat relapsing forms of the chronic, inflammatory autoimmune disease in adult patients.

“Approving safe and effective generics so patients have more treatment options continues to be a priority for the FDA,” said CDER Director Janet Woodcock.

Gilenya raked in $3.3 billion in worldwide revenue for Novartis in 2018, making it the company’s top-earning drug.

Novartis is currently in court fighting to extend its exclusivity for the drug. Until the patent issues are sorted out, no generic versions of Gilenya may enter the U.S. market.

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