FDA Clocks VYLOY's Review for Extra Patent Years
Published Date: 4/3/2026
Notice
Summary
The FDA has officially set the review period for VYLOY, a human biological product, so its patent holder can apply for extra patent time. This affects the company behind VYLOY, giving them a chance to extend their patent protection and potentially boost profits. If anyone thinks the dates are wrong or wants to challenge the company’s review speed, they must act by June 2 or September 30, 2026.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
VYLOY patent-extension eligibility set
The FDA determined the regulatory review period for the biologic VYLOY is 2,471 days: a 1,945-day testing phase and a 526-day approval phase. Key dates are: IND effective January 14, 2018; BLA submitted May 12, 2023; BLA approved October 18, 2024. This determination establishes the maximum potential patent-extension period and the applicant has applied to the USPTO seeking extensions of 66; 671; 990; 1,028; 1,319; 1,340; 1,406; 1,410; or 1,499 days for the listed patents.
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Key Dates
Department and Agencies
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