FDA Grants VYALEV Extra Patent Time for Regulatory Delay
Published Date: 6/29/2026
Notice
Summary
The FDA has officially set the review period for the drug VYALEV, which helps the company extend its patent protection. This means the patent clock can be paused, giving the drug maker more time to sell VYALEV exclusively. If anyone thinks the dates are wrong or the company wasn’t diligent, they can speak up by late 2026.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
FDA Sets VYALEV Patent Review Period
FDA determined the regulatory review period for the drug VYALEV is 2,871 days total — 1,989 days for testing and 882 days for approval. FDA lists the testing start date as December 8, 2016, the new drug application submission as May 19, 2022, and approval as October 16, 2024, and notes the applicant (AbbVie Inc.) seeks 1,091 days of patent term extension. This determination establishes the maximum potential length of a patent extension; interested parties may ask for a redetermination by August 28, 2026 or petition about due diligence by December 28, 2026.
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