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7 August 2019Big PharmaSaman Javed

Akebia Therapeutics and Par Pharma settle Auryxia suit

A subsidiary of Akebia Therapeutics has entered into a settlement agreement with Endo-owned Par Pharmaceutical.

In an announcement on Monday, August 5, US-based Akebia said the agreement would end all patent litigation between the parties.

Its subsidiary, Keryx Biopharmaceuticals and licensor Panion & BF Biotech had brought the action against Par after it sought approval to market a generic version of Auryxia.

Keryx had argued that its patents covering the drug were still valid and not yet expired.

Auryxia is used to control phosphorus levels in adults with chronic kidney disease who are on dialysis. It is also used to treat anemia in adults with chronic kidney disease who are not on dialysis.

Under the terms of the confidential agreement, Keryx and Panion will grant Par a licence to market its generic version of Auryxia in the US beginning on March 20, 2025.

This will be subject to approval from the US Food and Drug Administration.

Additionally, the agreement will terminate all ongoing Hatch-Waxman litigation between the parties regarding Auryxia patents pending in the US District Court for the District of Delaware and the US District Court for the Southern District of New York.

John Butler, president and CEO of Akebia, welcomed the announcement.

“We are pleased to have reached this settlement and believe it reinforces the strength of our intellectual property, including the 15 patents that cover Auryxia,” he said.

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