FDA Clocks ORLYNVAH Review for Patent Perks: Business as Usual
Published Date: 2/26/2026
Notice
Summary
The FDA has set the official review period for ORLYNVAH, a human drug, which helps decide how long its patent can be extended. This affects the drug’s maker by potentially giving them more time to protect their invention and earn money. If anyone thinks the dates are wrong or wants to challenge the company’s effort during review, they have until April 27 or August 25, 2026, to speak up.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
ORLYNVAH Review Period Set at 3,131 Days
The FDA determined the regulatory review period for the drug ORLYNVAH is 3,131 days total — 1,700 days in the testing phase and 1,431 days in the approval phase. The dates underlying this determination are: IND effective April 1, 2016; NDA initially submitted November 25, 2020; NDA approved October 25, 2024. This determination establishes the maximum potential length of any patent term extension the company may receive.
Deadlines To Challenge Dates or Diligence
Anyone who believes the published dates are incorrect may request a redetermination by April 27, 2026, and any interested person may petition FDA about whether the applicant acted with due diligence by August 25, 2026. Petitions must follow the procedures in 21 CFR 60.24 and 21 CFR 60.30 and be submitted electronically or in writing as described in the notice.
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Key Dates
Department and Agencies
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