Heart Valve Patent Gets FDA Time Extension Boost
Published Date: 6/16/2025
Notice
Summary
The FDA has set the official review period for the NAVITOR Transcatheter Aortic Valve Implant, a heart device. This helps the company extend its patent, giving them more time to protect their invention. If you’re in medical tech or patent law, watch for this update—it could affect when the device stays exclusive and impacts market competition.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
FDA Sets Review Period for NAVITOR
The FDA has determined the regulatory review period for the NAVITOR Transcatheter Aortic Valve Implant. That determination is being published because the company submitted applications to the U.S. Patent and Trademark Office seeking extension of a patent that claims this medical device, which helps the company seek more time to protect its invention.
Potential Extended Exclusivity and Competition
Because the regulatory review period determination supports a patent extension application, the NAVITOR device could remain under patent protection for a longer time. This could affect when the device stays exclusive and could impact market competition among medical device makers and suppliers.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2025-01840, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA’s new rule about nonprescription drugs needing extra conditions before use was set to start on January 27, 2025, but it’s now delayed until March 21, 2025. This delay follows a presidential order to pause and review new rules before they take effect. Drug makers, sellers, and consumers should note the new start date and get ready for the updated rules soon.
2026-19350, Nonclinical Testing Terminology
The FDA is updating its rules to replace the words “animal” tests with “nonclinical” tests, making room for new, smarter ways to check drug safety without relying only on animal testing. This change affects drug makers and researchers but won’t add new costs or requirements. The rule kicks in on February 4, 2027, and comments are open until December 7, 2026.
2026-19349, Nonclinical Testing Terminology
The FDA wants to update its rules by swapping out the word “animal” tests for “nonclinical” tests to better reflect modern science. This change affects drug safety testing rules, encourages new testing methods that might use fewer animals, and doesn’t add any new costs or requirements. Anyone interested can comment on these changes until December 7, 2026.
Previous / Next Documents
Previous: 2025-11033, Noise Compatibility Program for Laredo International Airport, Webb County, Texas; Correction
The FAA fixed a date mistake in the noise plan for Laredo International Airport that affects local residents and businesses near the airport. This correction clears up when the City of Laredo submitted important noise maps, helping everyone stay on the same page. No new costs or deadlines change, just a clearer timeline for noise management.
Next: 2025-11038, Determination of Regulatory Review Period for Purposes of Patent Extension; ZEVTERA
The FDA has officially set the review period for ZEVTERA, a human drug product, so its patent can be extended. This means the company behind ZEVTERA gets more time to protect their invention, helping them keep making and selling the drug. If you’re in the drug business or follow patents, this update shows when and how patent extensions happen.