Akebia Therapeutics Announces Settlement of Auryxia Patent Litigation with Par Pharmaceutical

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Akebia Therapeutics, Inc. (Nasdaq: AKBA), today announced that its wholly-owned subsidiary, Keryx Biopharmaceuticals, Inc., and its licensor Panion & BF Biotech, Inc., have entered into a Settlement and License Agreement (Agreement) with Par Pharmaceutical, Inc., an Endo International company (Par). This settlement resolves patent litigation brought by Keryx and Panion in response to Par’s Abbreviated New Drug Application (ANDA) 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 Agreement, the companies will grant Par a license to market its generic version of Auryxia in the United States beginning on March 20, 2025 (subject to U.S. FDA 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 Hatch-Waxman litigation between Keryx and Panion and Par regarding Auryxia patents pending in the U.S. District Court for the District of Delaware and the U.S. District Court for the Southern District of New York.

The Agreement is confidential and subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice.

“We are pleased to have reached this settlement and believe it reinforces the strength of our intellectual property, including the fifteen patents listed in the Orange-Book that cover Auryxia,” stated John P. Butler, President and Chief Executive Officer of Akebia.

About Akebia Therapeutics

Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people with kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release.

About Auryxia^® (ferric citrate) Tablets

Auryxia (ferric citrate) was approved by the FDA on September 5, 2014 for the control of serum phosphorus levels in adult patients with chronic kidney disease (CKD) on dialysis and approved by the FDA on November 6, 2017 for the treatment of iron deficiency anemia in adult patients with CKD not on dialysis. For more information about Auryxia and the U.S. full prescribing information, please visit www.auryxia.com.