Amicus Therapeutics settles Galafold patent litigation with Teva

Amicus Therapeutics has entered into a license agreement with Teva Pharmaceuticals USA and Teva Pharmaceuticals. This agreement resolves the patent litigation brought by Amicus in response to Teva’s Abbreviated New Drug Application seeking approval to market a generic version of Galafold (migalastat) 123 mg capsules before the expiration of the applicable patents.

Under the terms of the agreement, Amicus will grant Teva a license to market its generic version of Galafold in the United States beginning on Jan. 30, 2037, if approved by the Food and Drug Administration and unless certain limited circumstances customarily included in these types of agreements occur. 

Following 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 Aurobindo as the remaining active party and the litigation stay remains in place for Lupin.

[Read more: FDA gives tentative OK for Lupin’s generic Galafold]

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