FDA Grants Extra Patent Time for BEYFORTUS Baby Drug
Published Date: 6/16/2025
Notice
Summary
The FDA has officially set the review period for BEYFORTUS, a human biological product, so its patent can be extended. This means the company behind BEYFORTUS gets extra time to protect their invention and keep making money. Anyone interested in patent timing or drug development should take note of this important update.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
FDA OKs Patent Extension Timing
The FDA has determined the regulatory review period for BEYFORTUS so the patent holder can seek an extension of the patent that claims this human biological product. This gives the company extra time to protect the invention and continue earning revenue from the product.
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: 2025-11042, Submission for OMB Review; Comment Request; Reinstatement
The USDA is bringing back the Local Food Marketing Practices Survey to keep track of how local foods are grown and sold. This helps farmers, shoppers, and policymakers make smart choices about local food. If you have thoughts, you’ve got until July 16, 2025, to share them—no cost, just your voice!
Next: 2025-11044, Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting
The Mid-Atlantic Fishery Management Council and the Atlantic States Marine Fisheries Commission are teaming up for a public meeting about Summer Flounder, Scup, and Black Sea Bass. Fishermen, seafood lovers, and coastal communities will hear about possible changes to fishing rules that could affect when and how much fish can be caught. This meeting is a key step toward smart, fair fishing that protects fish and supports local economies.