Generic versions of Novartis blockbuster MS drug Gilenya gets USFDA green flag

The approval allows HEC Pharm Co Ltd, Biocon Ltd and Sun Pharmaceutical Industries Ltd to produce Gilenya for the treatment of relapsing forms of MS in adult patients.

New Delhi: The U.S. Food and Drug Administration on Thursday approved three generic versions of Swiss drugmaker Novartis AG's top-selling multiple sclerosis (MS) medicine Gilenya.

The approval allows HEC Pharm Co Ltd, Biocon Ltd and Sun Pharmaceutical Industries Ltd to produce the drug for the treatment of relapsing forms of MS in adult patients.

Novartis was defending patents on Gilenya in the United States to block generic rivals.

Read Also: Novartis Expiry of Patent for Blockbuster Vildagliptin to Clear Way for Competitors

Earlier in June, U.S. federal court order had prevented rival generic makers from selling versions of Gilenya in the United States.

Nearly a decade after its U.S. approval, Gilenya remains Novartis's No. 2 revenue generator at $829 million in the third quarter.

Read Also: Amgen wins patent battle against Novartis for blockbuster arthritis drug Enbrel