AKBA - Akebia settles last patent lawsuit related to kidney disease therapy

2023-06-02 09:30:53 ET

Akebia Therapeutics ( NASDAQ: AKBA ) announced Friday that its subsidiary Keryx Biopharmaceuticals and licensing partner Panion & BF Biotech settled the last patent litigation related to generic versions of its kidney disease therapy Auryxia.

Counterparties to the latest settlement, Zydus Worldwide DMCC, Zydus Pharmaceuticals (USA) Inc., and Zydus Lifesciences Limited were previously on track to launch their generic before the expiry of certain Auryxia patents.

In response to an Abbreviated New Drug Application (ANDA) submitted by Zydus, Keryx and Panion have challenged its market entry, filing a lawsuit in a Delaware district court.

The settlement and license agreement resolved the ongoing litigation giving a license for Zydus to market an Auryxia generic starting on March 20, 2025, or earlier, subject to certain conditions, Akebia ( AKBA ) said.

The agreement signed on May 30 is in line with the previous settlements Keryx reached with generic drugmakers, including Teva Pharmaceuticals ( TEVA ) and Mylan Pharmaceuticals, the company noted.

With the Zydus deal, Keryx and Panion have resolved all patent litigations filed in response to attempts by third parties to market generic versions of Auryxia tablets before the expiry of relevant patents.

Auryxia, known as ferric citrate, is AKBA’s only commercial product, and the company generated $177.1M net product revenue in 2022, with ~25% YoY growth.

For further details see: