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3277270 in the European Patent Office.
+Added: An oral hearing is scheduled for February 6, 2024.
On February 13, 2023, FibroGen, Inc., or FibroGen , filed an opposition against our issued European Patent No.
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We do not expect the UK Court of Appeal’s judgment to have any effect on our commercialization of vadadustat in the UK because the patents expired in December 2022.
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 39
Legal Proceedings Relating to Auryxia
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In February 2023, Keryx Biopharmaceuticals, Inc., or Keryx , received a Paragraph IV certification notice letter regarding an Abbreviated New Drug Application, or ANDA , submitted to the U.S.
−Removed: Food and Drug Administration, or FDA by Zydus Worldwide DMCC, or Zydus, requesting approval for a generic version of Auryxia tablets (210 mg ferric iron per tablet).
−Removed: On March 24, 2023, Keryx and Panion & BF Biotech, Inc., or Panion, filed a complaint for patent infringement against Zydus, Zydus Pharmaceuticals (USA) Inc., and Zydus Lifesciences Limited in the Delaware District Court arising from Zydus’ ANDA filing with the FDA.
+Added: Food and Drug Administration, or FDA , by Zydus Worldwide DMCC requesting approval for a generic version of Auryxia tablets (210 mg ferric iron per tablet).
+Added: On March 24, 2023, Keryx and Panion & BF Biotech, Inc., or Panion , filed a complaint for patent infringement against Zydus Worldwide DMCC, Zydus Pharmaceuticals (USA) Inc., and Zydus Lifesciences Limited, or collectively Zydus , in the Delaware District Court arising from Zydus’ ANDA filing with the FDA.
+Added: On May 30, 2023, Keryx and Panion entered into a settlement and license agreement with Zydus, which resolved the patent litigation brought by Keryx and Panion.
+Added: Such settlement and license agreement, consistent with Keryx’s prior ANDA settlements, granted Zydus a license to market a generic version of Auryxia in the United States beginning on March 20, 2025 (subject to FDA approval), or earlier under certain circumstances customary for settlement agreements of this nature.
+Added: Additionally, in accordance with the settlement and license agreement, the parties terminated all ongoing litigation among Keryx, Panion, and Zydus regarding Auryxia patents pending in the Delaware District Court.
+Added: The settlement and license agreement is confidential and subject to review by the U.S.
+Added: Federal Trade Commission and the U.S.
+Added: Department of Justice.
+Added: On June 5, 2023, the Delaware District Court entered a stipulation and order of dismissal filed by the parties to terminate the action against Zydus.
Stockholder Litigation Relating to the Merger
−Removed: On June 28, 2018, we entered into an Agreement and Plan of Merger with Keryx and Alpha Therapeutics Merger Sub, Inc., or the Merger Sub, pursuant to which the Merger Sub would merge with and into Keryx, with Keryx becoming a wholly owned subsidiary of ours, or the Merger.
+Added: On June 28, 2018, we entered into an Agreement and Plan of Merger with Keryx and Alpha Therapeutics Merger Sub, Inc., or the Merger Sub , pursuant to which the Merger Sub merged with and into Keryx, with Keryx becoming a wholly owned subsidiary of ours, or the Merger.
On December 12, 2018, we completed the Merger.
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Briefing on defendants’ motion to dismiss the amended consolidated complaint was completed on April 5, 2023.
−Removed: Oral argument is currently scheduled to be held on June 21, 2023.
+Added: Oral argument is currently scheduled to be held on October 18, 2023.
We deny any allegations of wrongdoing and intend to continue vigorously defending against the one active stockholder lawsuit described in this Legal Proceedings section, the Consolidated State Action.
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A resolution of the Consolidated State Action in a manner adverse to us, however, could have a material effect on our financial position and results of operations in the period in which the action is resolved.
+Added: Akebia Therapeutics, Inc.
+Added: | Form 10-Q | Page 40
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.