FDA Sets Review Clock for KEBILIDI Drug Patent Extension Purposes
Published Date: 2/13/2026
Notice
Summary
The FDA has set the official review period for KEBILIDI, a human biological product, so its patent holder can apply for extra patent time. This helps the company protect their invention longer, potentially affecting when generic versions can enter the market. If anyone thinks the dates are wrong or the company wasn’t diligent, they have until April or August 2026 to speak up.
Analyzed Economic Effects
5 provisions identified: 3 benefits, 1 costs, 1 mixed.
FDA Sets 1,612-Day Review Period
The FDA determined the regulatory review period for KEBILIDI is 1,612 days in total, with 1,368 days in the testing phase and 244 days in the approval phase. This determination establishes the maximum potential length of a patent extension that the patent holder may seek from the USPTO.
Applicant Requests Specific Extension Days
In its patent extension application to the USPTO, the applicant for KEBILIDI seeks either 277 days or 816 days of patent term extension. The USPTO will apply statutory limitations when calculating any actual extension.
Possible Delay to Generic Market Entry
The FDA notice states the determination lets the patent holder apply for extra patent time, which can protect the invention longer and potentially affect when generic versions can enter the market. That timing can influence when patients and purchasers may see generic alternatives.
FDA Identifies Key IND/BLA Dates
FDA records show the IND effective date for KEBILIDI was June 17, 2020 (the applicant claimed March 29, 2020), the biologics license application was initially submitted on March 15, 2024, and the application was approved on November 13, 2024. These specific dates were used to derive the testing and approval phase lengths that underlie the regulatory review period.
Deadlines to Challenge Dates or Diligence
Anyone who believes the published dates are incorrect must ask for a redetermination by April 14, 2026. Any interested person may petition FDA regarding whether the applicant acted with due diligence during the regulatory review period by August 12, 2026.
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