FDA Sets Patent-Extension Clock for an Infant Virus Prevention Product
Published Date: 6/16/2025
Notice
Summary
The FDA has officially set the review period for BEYFORTUS, a human biological product, so its patent holder can apply for extra patent time. This helps the company protect their invention longer, encouraging innovation. If anyone thinks the dates are wrong or wants to challenge the company’s diligence, they must act by mid or late 2025.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
FDA Sets BEYFORTUS Review Period
The FDA determined the regulatory review period for BEYFORTUS is 3,387 days in total, with 3,092 days in the testing phase and 295 days in the approval phase. The agency verified the key dates used: investigational exemption effective April 10, 2014; biologics license application (BLA B761328) submitted September 26, 2022; and approval on July 17, 2023. This determination establishes the maximum potential length of a patent extension for BEYFORTUS.
Applicant Seeks Specific Extension Lengths
In its applications to the U.S. Patent and Trademark Office, the patent applicant seeks patent-term extensions of 49 days, 445 days, or 708 days for BEYFORTUS. The USPTO will apply statutory limitations when calculating the actual extension awarded.
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Key Dates
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