Kidney Nerve Zapper: Hypertension Device Patent Extended
Published Date: 1/27/2026
Notice
Summary
The FDA has officially set the review period for the Symplicity Spyral Renal Denervation System, a medical device used to treat high blood pressure. This means the company can apply to extend its patent, giving them more time to protect their invention and potentially earn more money. If you want to share your thoughts, you have until March 30, 2026, to send in comments.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
FDA Sets 3,161‑Day Review Period
The FDA determined the regulatory review period for the SYMPLICITY SPYRAL RENAL DENERVATION SYSTEM is 3,161 days: 2,801 days in the testing phase and 360 days in the approval phase. That determination lets the patent holder apply to the U.S. Patent and Trademark Office for patent term extension — the applicant seeks 1,491, 1,571, or 1,767 days of extension.
Public Comment and Petition Window
Anyone can submit comments on FDA's determination through https://www.regulations.gov or by mail until 11:59 p.m. Eastern Time on March 30, 2026. Under 21 CFR 60.24 and 21 CFR 60.30, interested persons may ask for a redetermination of the published dates or petition regarding whether the applicant acted with due diligence, and such petitions must be timely and meet the filing requirements described in the notice.
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Key Dates
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The FDA has set the official review period for the drug TRYVIO, which helps the company extend its patent protection. This means the drug maker could get extra time to keep exclusive rights, potentially affecting when generic versions can appear. If anyone thinks the dates are wrong or wants to challenge the company’s effort during review, they have until March 30 or July 27, 2026, to speak up.
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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.