Amicus Resolves Patent Litigation Over Aurobindo, Lupin Generic Filings For Galafold 123 mg Capsules

Pending U.S. Galafold IP Litigation Resolved 

Separately, Amicus has resolved the patent litigation it brought in response to Aurobindo Pharma's and Lupin Ltd.'s Abbreviated New Drug Applications seeking approval to market a generic version of Galafold 123 mg capsules prior to expiration of the certain Amicus patents.  In connection with the resolution of the patent litigation, Amicus entered into License Agreements with Aurobindo and Lupin for Galafold 123 mg capsules. Pursuant to the terms of the agreements, Amicus will grant Aurobindo and Lupin licenses to market generic versions 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. As required by law, the companies will submit the confidential license agreements to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. In accordance with the agreements, the parties will terminate all ongoing Hatch-Waxman litigation between Amicus and Aurobindo and Lupin regarding Galafold patents pending in the U.S. District Court for the District of Delaware.