Novartis announces U.S. Court of Appeals for the Federal Circuit upholds validity of Gilenya dosage regimen patent.

In August 2020, the U.S. Federal District Court for the District of Delaware issued a favorable decision in the Gilenya patent litigation and a permanent injunction was granted against HEC Pharma until the expiration of the ‘405 patent in December 2027 (including pediatric exclusivity). HEC Pharma was the only remaining Abbreviated New Drug Application (ANDA) filer challenging this patent. This decision confirms the validity of the patent and allows that injunction to remain in place.

Previously, Novartis entered into settlement agreements with a number of ANDA filers. Those ANDA filers will not be able to launch a generic version of Gilenya, if approved by the FDA, before an agreed upon date that is prior to the expiration of the dosage regimen patent in December 2027. The potential generic entry date and other terms of the settlement agreement are confidential. With this decision, Novartis confirms that it expects no generic versions of Gilenya in the US market for at least the next two years.