Determination of Regulatory Review Period for Purposes of Patent Extension; COBENFY
Published Date: 2/6/2026
Notice
Summary
The FDA has set the official review period for COBENFY, a human drug, so its patent holder can apply for extra patent time. This affects the drug company and anyone tracking patent protections, with deadlines to challenge dates or diligence claims by April 7 and August 5, 2026. It’s a key step to help the company protect its invention longer, potentially impacting when generic versions can enter the market.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
FDA sets COBENFY review period
FDA determined COBENFY's regulatory review period is 11,751 days total (testing phase 11,384 days and approval phase 367 days). FDA lists the IND effective date as July 27, 1992, the NDA initial submission as September 26, 2023, and the NDA approval as September 26, 2024; the applicant seeks 1,124 or 1,191 days of patent term extension and the USPTO will apply statutory limits when calculating the actual extension.
Deadlines to challenge dates or diligence
Anyone who believes the published dates are incorrect may ask FDA for a redetermination by April 7, 2026, and any interested person may petition FDA about whether the applicant acted with due diligence by August 5, 2026. Petitions and comments must follow the submission instructions in the notice (including using https://www.regulations.gov or written submissions).
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Key Dates
Department and Agencies
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