ABRYSVO's Patent Review Period Locked In by FDA
Published Date: 7/14/2025
Notice
Summary
The FDA has officially set the review period for ABRYSVO, a new human biological product. This means the company can apply to extend its patent, giving them more time to protect their invention. If approved, this could affect when generic versions hit the market and impact future drug prices.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
FDA Sets Review Period for ABRYSVO
The FDA has determined the regulatory review period for ABRYSVO, a human biological product. The company submitted an application to the U.S. Patent and Trademark Office to extend a patent that claims ABRYSVO, allowing the company to seek additional time to protect its invention.
Possible Delay of Generics and Price Effects
If the patent extension for ABRYSVO is approved, it could delay when generic versions reach the market and could affect future drug prices. This change would influence when patients and buyers can access lower-cost alternatives.
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.
2026-17401, Determination That CABAZITAXEL (Cabazitaxel) Solution (Injection), 60 Milligrams/6 Milliliters (10 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA, Agency, or we) has determined that CABAZITAXEL (cabazitaxel) solution (injection), 60 milligrams (mg)/6 milliliters (mL) (10 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for Cabazitaxel (cabazitaxel) solution (injection), 60 mg/6 mL (10 mg/mL), if all other legal and regulatory requirements are met.
2026-17380, International Drug Scheduling; Single Convention on Narcotic Drugs; Convention on Psychotropic Substances; Clobromazolam (Phenazolam); Cychlorphine (N-Propionitrile Chlorphine); Desalkylgidazepam (Bromonordiazepam); Ethylbromazolam; Etomethazene (5-Methyl Etodesnitazene); Spirochlorphine (R6980); Etomidate; Medetomidine; Request for Comments
The FDA is asking the public to share their thoughts on eight drugs that might get new international rules to control their use and abuse. This affects doctors, patients, and drug makers because it could change how these drugs are used medically or restricted worldwide. Comments are open until September 3, 2026, so jump in and have your say before the deadline!
2026-17222, Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry titled "Bioequivalence Recommendations for Specific Products" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.
Previous / Next Documents
Previous: 2025-13045, Silver Point Specialty Credit Fund Management, LLC, et al.
Silver Point Specialty Credit Fund Management wants permission to offer different types of shares with various fees and sales charges to investors. This change affects certain investment companies and could impact how much investors pay in fees. People have until August 4, 2025, to ask for a hearing before the SEC decides.
Next: 2025-13047, Agency Information Collection Activities; Proposed Collection; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3
The FDA wants your thoughts on continuing their study about how well the Real Cost Campaign helps people make healthier choices. This study affects teens and young adults by tracking their habits over time. They’re asking for comments within 60 days—no new costs, just a chance to share your opinion!