REVUFORJ Gets FDA Patent Timer: Generic Delays on Deck
Published Date: 2/26/2026
Notice
Summary
The FDA has set the official review period for the drug REVUFORJ, which helps the company extend its patent and protect their invention longer. This affects the drug maker and anyone tracking patent timelines, with deadlines to challenge or comment by April 27 and August 25, 2026. It’s a key step in making sure the patent extension process is fair and on schedule, potentially impacting when generic versions can enter the market.
Analyzed Economic Effects
4 provisions identified: 3 benefits, 0 costs, 1 mixed.
FDA Sets REVUFORJ Review Length
The FDA determined REVUFORJ had a regulatory review period of 1,969 days total: 1,674 days in the testing phase and 295 days in the approval phase. Those totals are based on an investigational exemption effective June 28, 2019, an NDA submission on January 26, 2024, and approval on November 15, 2024.
Applicant Requests 525-Day Patent Extension
The patent applicant (Vitae Pharmaceuticals, LLC) has applied to the USPTO seeking 525 days of patent term extension for U.S. Patent No. 10,683,302 covering REVUFORJ. FDA's determination of the regulatory review period establishes the maximum potential length of any extension the USPTO may consider.
Determination May Affect Generic Entry Timing
FDA’s determination establishes the maximum potential patent extension period that the USPTO may use when calculating any patent term restoration, and the USPTO will apply statutory limitations in its final calculation. That process can affect when generic versions of REVUFORJ are legally able to enter the market.
Deadlines to Challenge or Petition
Anyone who believes the published dates are incorrect may ask for a redetermination by April 27, 2026, and any interested person may petition FDA about the applicant's diligence during the regulatory review period by August 25, 2026. Petitions must meet the requirements in 21 CFR 60.30 and be timely and properly filed.
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