FDA Grants Extra Patent Time for Mystery Drug GRAFAPEX
Published Date: 12/10/2025
Notice
Summary
The FDA has set the official review period for the drug GRAFAPEX, which helps the company extend its patent protection. This means the drug maker could get more time to exclusively sell GRAFAPEX, potentially affecting competition and profits. People can challenge the dates or the company’s effort in the review process by early to mid-2026.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
FDA sets GRAFAPEX review period
FDA determined the regulatory review period for the drug GRAFAPEX (treosulfan) is 9,906 days total: 8,281 days in the testing phase and 1,625 days in the approval phase. The key dates are: IND effective December 10, 1997; NDA submitted August 11, 2020; and approval on January 21, 2025. This determination establishes the maximum potential length of a patent extension and the applicant is seeking 5 years of patent term extension.
Public can challenge dates and diligence
Anyone with knowledge that the published dates are incorrect may ask FDA for a redetermination by February 9, 2026, and any interested person may petition FDA regarding whether the applicant acted with due diligence during the regulatory review period by June 8, 2026. Instructions for electronic and written submissions are provided in the notice.
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Key Dates
Department and Agencies
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