FDA Patent Review Notice Could Affect Generic Competition for VAFSEO
Published Date: 6/16/2025
Notice
Summary
The FDA has officially set the review period for the drug VAFSEO, which helps the company extend its patent protection. This means the drug maker could get extra time to keep their invention exclusive, potentially affecting when generic versions can enter the market. If anyone thinks the dates are wrong or wants to challenge the company’s effort during the review, they have until mid-2025 to speak up.
Analyzed Economic Effects
4 provisions identified: 1 benefits, 3 costs, 0 mixed.
FDA sets VAFSEO review period and extension request
FDA determined the regulatory review period for VAFSEO (vadadustat) is 5,336 days in total—4,241 days in the testing phase and 1,095 days in the approval phase. The applicant (Akebia Therapeutics, Inc.) seeks 1,094 days of patent term extension based on that period.
Specific dates that define the review period
FDA verified the investigational new drug (IND) effective date as August 19, 2009, the new drug application (NDA 215192) submission date as March 29, 2021, and the approval date as March 27, 2024. Those dates were used to calculate the 5,336-day regulatory review period.
Opportunities to challenge dates or due diligence
Anyone who believes the published dates are incorrect may submit comments and request a redetermination by August 15, 2025. Any interested person may petition FDA to determine whether the applicant acted with due diligence during the regulatory review period by December 15, 2025.
Patents named in the extension applications
The USPTO received patent term restoration applications for VAFSEO for U.S. Patent Nos. 7,811,595; 8,323,671; 8,343,952; 8,598,210; and 8,940,773 from Akebia Therapeutics, Inc., and asked FDA to determine eligibility for restoration.
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