UNITED STATES
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CURRENT REPORT PURSUANT TO
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Item 8.01 Other Events.
On October 15, 2024, Amicus Therapeutics, Inc. (the “Company”) and its subsidiary Amicus Therapeutics US, LLC (collectively, “Amicus”), entered into a license agreement with Teva Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc. (collectively, “Teva”) resolving the previously disclosed patent litigation concerning the submission by Teva of an Abbreviated New Drug Application (“ANDA”) seeking approval to market a generic version of Galafold® (migalastat) 123 mg oral capsules prior to the expiration of Amicus’s Orange Book listed patents (the “License Agreement”).
Under the terms of the License Agreement, among other things, Amicus granted Teva a non-exclusive, non-transferable, royalty-free, fully paid-up license to commercialize its generic version of Galafold in the United States commencing on January 30, 2037, or earlier in certain circumstances. The parties will file the License Agreement with the Federal Trade Commission and the Department of Justice, pursuant to applicable law, and will terminate their pending litigation pursuant to a consent judgment and permanent injunction that is subject to court approval. Similar patent litigation previously disclosed by the Company will continue against Aurobindo (Aurobindo Pharma LTD and Aurobindo Pharma USA, Inc.) as the remaining active party and the litigation stay remains in place for Lupin (Lupin LTD and Lupin Pharmaceuticals, Inc.).
Signature Page
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AMICUS THERAPEUTICS, INC. | ||
| Date: October 17, 2024 | By: | /s/ Ellen S. Rosenberg |
| Name: | Ellen S. Rosenberg | |
| Title: | Chief Legal Officer and Corporate Secretary | |