VOYDEYA Patent-Extension Timeline Gets Official FDA Determination
Published Date: 6/16/2025
Notice
Summary
The FDA has officially set the review period for VOYDEYA, a human drug, which helps the company extend its patent protection. If anyone thinks the dates are wrong, they can speak up by August 15, 2025, and questions about the company's effort during review can be raised by December 15, 2025. This means VOYDEYA’s makers might get more time to protect their invention, potentially affecting competition and market timing.
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
FDA sets VOYDEYA review period length
FDA determined the regulatory review period for VOYDEYA is 2,355 days in total, consisting of a 1,989-day testing phase and a 366-day approval phase. The testing phase began with an investigational new drug effective date of October 19, 2017, the new drug application was submitted on March 30, 2023, and the application was approved on March 29, 2024.
Applicant requests 1,358-day patent extension
In its application to the U.S. Patent and Trademark Office, the applicant for VOYDEYA (U.S. Patent No. 9,796,741) seeks 1,358 days of patent term extension. FDA notes that its determination establishes the maximum potential length of a patent extension, while the USPTO will apply statutory limitations in calculating the actual extension.
Public comment and petition deadlines
Anyone who believes the published dates are incorrect may submit electronic or written comments and ask for a redetermination by August 15, 2025. Any interested person may petition FDA about whether the applicant acted with due diligence during the regulatory review period by December 15, 2025, using the procedures and addresses provided (including https://www.regulations.gov).
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