Novartis wins patent protection for blockbuster MS drug

Aug. 18, 2020

Novartis has won an important victory in protecting a patent for its second-best selling medication. This week, unsealed documents showed that U.S. district court has upheld Novartis’ patent for Gilenya, a blockbuster treatment for multiple sclerosis.

The decision was a blow to several generic drugmakers, including HEC Pharm, which has an FDA-approved generic version of Gilenya. But Novartis is reportedly in settlement talks with several drug manufacturers involved in the lawsuit and may ultimately agree to let them release generic versions of Gilenya before its patent expires in 2027.

In anticipation of the $3-billion-a-year drug falling off the patent cliff, three generic drugmakers — HEC Pharm, Sun Pharmaceutical and Biocon — have already won FDA approval for their copycat versions of Gileyna.

Read the full Reuters report.