Akebia Therapeutics, Inc. (NASDAQ: AKBA) announced that a new patent has been granted and listed in the FDA's Orange Book, while receiving notification of eligibility to extend the expiration of a composition of matter patent covering its drug Vafseo (vadadustat).

The company's vadadustat intellectual property portfolio now includes 14 patents listed in the Orange Book with expiration dates extending to 2036. The newly issued patent, U.S. Patent No. 12,569,474, expires in June 2034 and relates to a once daily dosing regimen for treating anemia secondary to or associated with chronic kidney disease.

A separate composition of matter patent covering vadadustat is eligible for patent term extension under 35 U.S.C. 156 for five years, extending the patent term to mid-2032 upon issuance of the Certificate of Extension by the United States Patent and Trademark Office.

Vafseo, an oral hypoxia-inducible factor-prolyl hydroxylase inhibitor, was approved by the FDA in March 2024 for treating anemia due to chronic kidney disease in adults who have been receiving dialysis for at least three months. The drug has been available in the U.S. since January 2025.

According to the company, there are no other oral HIF-PH inhibitors to treat anemia in the market or in development in the U.S. Vafseo is approved for use in 37 countries.

The company has additional patents listed in the Orange Book with expiration dates between 2027 and 2036, and has pending applications that could expire as late as 2042 if issued.