BRIUMVI Gets an FDA Review Timeline for Patent Extension
Published Date: 6/16/2025
Notice
Summary
The FDA has set the official review period for BRIUMVI, a new medicine, so its patent can be extended. This helps the company behind BRIUMVI get extra time to protect their invention. If anyone thinks the dates are wrong or wants to challenge the company’s effort during the review, they must speak up by August 15 or December 15, 2025.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
FDA sets 3,920-day review period for BRIUMVI
The FDA determined BRIUMVI’s regulatory review period is 3,920 days total, made up of a 3,463-day testing phase and a 457-day approval phase. FDA verified the key dates used: the investigational new drug effective date of April 6, 2012; biologics license application (BLA 761238) submission on September 28, 2021; and approval on December 28, 2022. This determination establishes the maximum potential basis for a patent term extension for the product.
Deadlines to challenge dates and applicant diligence
Anyone who believes the published dates are incorrect may submit comments and ask for a redetermination by August 15, 2025. Any interested person may petition FDA about whether the patent applicant acted with due diligence during the regulatory review period by December 15, 2025, following the procedures in 21 CFR 60.24 and 60.30.
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