Akebia Therapeutics Inc (AKBA)

[StkMktPirate]

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On September 24, 2020, Keryx Biopharmaceuticals, Inc. (“Keryx”), a wholly owned subsidiary of Akebia Therapeutics, Inc., and its licensors, Panion & BF Biotech, Inc. (“Panion”) and Chen Hsing Hsu, M.D. entered into a settlement and license agreement with Lupin Atlantis Holdings SA (“Lupin”) and Lupin Ltd. This settlement resolves patent litigation brought by Keryx and Panion in response to Lupin and Lupin Ltd.’s Paragraph IV certification notice letters regarding their Abbreviated New Drug Applications (“ANDAs”) seeking approval to market a generic version of Auryxia® (ferric citrate) tablets prior to the expiration of the applicable patents. Pursuant to the terms of the settlement, and consistent with Keryx’s prior ANDA settlements with Teva Pharmaceuticals USA, Inc. and its wholly owned, indirect subsidiary, Watson Laboratories, Inc., and with Par Pharmaceutical, Inc., Keryx and Panion will grant Lupin and Lupin Ltd. a license to market a generic version of Auryxia in the United States beginning on March 20, 2025 (subject to U.S. Food and Drug Administration approval), or earlier under certain circumstances customary for settlement agreements of this nature. Additionally, in accordance with the agreement, the parties will terminate all ongoing litigation among Keryx, Panion, Lupin, Lupin Ltd. and Dr. Hsu regarding Auryxia patents pending in the United States District Court for the District of Delaware. The settlement and license agreement is confidential and subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice.