IMAAVY Bio-Product Patent Review Locked In
Published Date: 1/27/2026
Notice
Summary
The FDA has officially set the review period for IMAAVY, a human biological product, which helps the company extend its patent protection. If anyone thinks the dates are wrong, they have until March 30, 2026, to speak up. Also, people can challenge whether the company acted quickly enough during the review by July 27, 2026. This means more time and money could be on the line for the patent holder and competitors.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Applicant requests 1,007‑day patent extension
In its patent-extension filing to the USPTO, Momenta Pharmaceuticals seeks 1,007 days of patent term extension for U.S. Patent No. 10,676,526 on IMAAVY. The FDA's regulatory‑period determination is part of the record the USPTO will use when calculating any actual extension.
FDA sets 2,453‑day review period
The FDA determined the regulatory review period for the biologic IMAAVY is 2,453 days in total: 2,209 days in the testing phase and 244 days in the approval phase. FDA verified the key dates as August 13, 2018 (IND effective), August 29, 2024 (BLA submission), and April 29, 2025 (approval); this determination establishes the maximum potential length of a patent extension.
IMAAVY approved for gMG in patients 12+
IMAAVY (nipocalimab-aahu) was approved by FDA on April 29, 2025 for treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti‑AChR or anti‑MuSK antibody positive. That approval represents the first permitted commercial marketing or use of the product.
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Key Dates
Department and Agencies
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