ATTRUBY's Patent Extension: FDA Sets the Clock for Challenges
Published Date: 2/13/2026
Notice
Summary
The FDA has set the official review period for ATTRUBY, a human drug, so its patent holder can apply for extra patent time. This affects the drug company by potentially extending their exclusive rights, giving them more time to make money before generics arrive. People can challenge the dates or the company’s effort by mid-2026, so keep an eye on those deadlines!
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
ATTRUBY review period enables patent extension
FDA determined the regulatory review period for the drug ATTRUBY is 2,648 days (testing phase 2,288 days; approval phase 360 days). The investigational new drug became effective August 25, 2017; the new drug application was submitted November 29, 2023; and FDA approved ATTRUBY on November 22, 2024. This determination establishes the maximum potential length of a patent extension, and the applicant seeks extensions of 910, 1,134, 1,404, or 1,504 days, which could give the patent holder more exclusive time to sell the drug before generics arrive.
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Key Dates
Department and Agencies
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