Determination of Regulatory Review Period for Purposes of Patent Extension; AURORA EV-ICD
Published Date: 2/6/2026
Notice
Summary
The FDA has officially set the review period for the AURORA EV-ICD, a medical device, so its patent can be extended. This means the company behind the device could get extra time to protect their invention, which might affect when generic versions can enter the market. Anyone interested has until February 6, 2026, to share their thoughts with the FDA.
Analyzed Economic Effects
1 provisions identified: 0 benefits, 1 costs, 0 mixed.
FDA Sets 1,521-Day Review Period
The FDA determined the regulatory review period for the AURORA EV-ICD is 1,521 days total (1,086 days in the testing phase and 435 days in the approval phase). That determination enables the patent owner to seek a patent-term extension (the applicant seeks either 297 or 868 days), which could affect when competing or generic versions can enter the market. The FDA is accepting comments on this determination through February 6, 2026.
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