FDA Extends Review Clock for ELREXFIO Biological Product
Published Date: 5/12/2025
Notice
Summary
The FDA has officially set the review period for ELREXFIO, a new human biological product. This means the company behind ELREXFIO can apply to extend their patent, giving them more time to protect their invention. This helps the company keep their exclusive rights longer, potentially affecting when generic versions can enter the market.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Patent-extension eligibility for ELREXFIO
The FDA has determined the regulatory review period for ELREXFIO. The company that makes ELREXFIO can apply to the U.S. Patent and Trademark Office to extend a patent that claims this human biological product, giving the company more time to protect its invention.
Timing of generics may be affected
Because the company can seek to extend its patent and keep exclusive rights longer, the timing of when generic versions of ELREXFIO can enter the market may be affected. That could change when lower-cost generic alternatives become available.
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.
2026-16959, Frequently Asked Questions-Developing Potential Cellular and Gene Therapy Products; Final Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Frequently asked Questions--Developing Potential Cellular and Gene Therapy Products." The guidance document provides industry with answers to frequently asked questions (FAQs) and commonly faced issues that arise during the development of cellular and gene therapy (CGT) products. The FAQs represent common questions directed to the Agency and span multiple disciplines, including regulatory review; chemistry, manufacturing, and controls (CMC); pharmacology/toxicology; clinical; and clinical pharmacology. This guidance announced in this notice finalizes the draft guidance of the same title issued on November 19, 2024.
2026-16942, Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium DL- methionine chelate as a nutritional source of chromium in cattle feed. This action is in response to a food additive petition filed by Zinpro Corp.
2026-16939, GNT USA, LLC.; Filing of Color Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by GNT USA, LLC., c/o Exponent, Inc., proposing that we amend our color additive regulations to provide for the safe use of safflower (Carthamus tinctorius L.) extract as a color additive in various foods at levels consistent with good manufacturing practices.
Previous / Next Documents
Previous: 2025-08255, Determination of Regulatory Review Period for Purposes of Patent Extension; LITFULO
The FDA has officially set the review period for LITFULO, a human drug product, so its patent can be extended. This helps the drug maker get extra time to protect their invention after the long approval process. If you’re involved in drug patents or development, this means important timing updates and potential market exclusivity changes.
Next: 2025-08257, Determination of Regulatory Review Period for Purposes of Patent Extension; NGENLA
The FDA has officially set the review period for NGENLA, a human biological product, so its patent can be extended. This helps the company get more time to protect their invention after going through the approval process. If you’re involved in biotech or patents, this means the clock is ticking on when the patent extension can be applied for.