Amicus Therapeutics Enters License Agreement With Teva, Resolving Galafold Patent Litigation; No Terms Disclosed

This Agreement resolves the patent litigation brought by Amicus in response to Teva's Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of GALAFOLD (migalastat) 123mg capsules prior to expiration of the applicable patents.

Pursuant to the terms of the Agreement, Amicus will grant Teva a license to market its generic version of GALAFOLD in the United States beginning on January 30, 2037, if approved by the U.S. Food and Drug Administration (FDA) and unless certain limited circumstances customarily included in these types of agreements occur.

In accordance with the Agreement, the parties will terminate all ongoing Hatch-Waxman litigation between Amicus and Teva regarding GALAFOLD patents pending in the U.S. District Court for the District of Delaware. The litigation will continue against Aurobindo1 as the remaining active party and the litigation stay remains in place for Lupin.