Amicus Therapeutics (Nasdaq: FOLD) announced that it has entered into a License Agreement (Agreement) with Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals, Inc. (collectively Teva). 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 Lupin².

As required by law, the companies will submit the confidential license agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.