Amicus Therapeutics (FOLD) has announced the resolution of its patent dispute with Teva Pharmaceuticals USA, Inc. through a License Agreement following Teva's submission of an Abbreviated New Drug Application (ANDA) for a generic version of GALAFOLD (migalastat) 123 mg capsules. This submission aimed to secure approval for the generic drug prior to the expiration of existing patents.
Under the agreement's terms, Amicus will provide Teva with a license to market its generic version of GALAFOLD in the United States starting on January 30, 2037, contingent on approval from the U.S. Food and Drug Administration (FDA). This timeline applies unless specific conditions typical in such agreements are met.
With this agreement, both companies have agreed to cease all ongoing litigation under the Hatch-Waxman Act in the U.S. District Court for the District of Delaware related to GALAFOLD patents. However, litigation will continue with Aurobindo as the remaining active defendant, while proceedings regarding Lupin remain on hold.
