FDA Sets Patent-Review Dates for Drugmaker's RIVFLOZA Extension Bid
Published Date: 6/16/2025
Notice
Summary
The FDA has officially set the review period for the drug RIVFLOZA, which helps the company extend its patent protection. This means the drug maker might get extra time to keep their invention exclusive, potentially affecting when generic versions can enter the market. People can challenge the dates or the company’s diligence by mid-December 2025, so keep an eye on those deadlines!
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
RIVFLOZA patent-extension potential
FDA set RIVFLOZA's regulatory review period at 2,013 days (1,648 days testing phase and 365 days approval phase). The drugmaker (Novo Nordisk) has applied for 722 days of patent term extension, which could give the company extra time to keep RIVFLOZA exclusive and potentially delay when generic versions can enter the market.
Deadlines to challenge dates or diligence
If you think the dates are wrong, you may submit comments asking FDA for a redetermination by August 15, 2025. If you want FDA to decide whether the applicant acted with due diligence during the regulatory review period, you may file a petition by December 15, 2025, following the rules in 21 CFR 60.24 and 21 CFR 60.30 and submitting to Docket No. FDA-2013-S-0610 (or by mail to the Dockets Management Staff).
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
2026-20848, Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods
The FDA is changing food rules to allow salt substitutes in many standardized foods, helping companies make lower-sodium options. This move aims to cut heart disease risks by reducing sodium without changing how foods basically taste or look. The new rule kicks in December 14, 2026, and food makers have until November 12, 2026, to raise any concerns, with no big costs expected.
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.
2025-04978, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA is delaying a new rule about nonprescription drugs that have extra conditions for use. Originally set to start on March 21, 2025, the rule’s start date is now pushed back to May 27, 2025, to allow more time for review. This affects drug makers and consumers by giving everyone extra time to prepare for the new requirements without any immediate cost changes.
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.
Previous / Next Documents
Previous: 2025-11039, Determination of Regulatory Review Period for Purposes of Patent Extension; VOWST
The FDA has officially set the review period for VOWST, a special human biological product, so its patent can be extended. This affects the company behind VOWST, giving them more time to protect their invention. If anyone thinks the dates are wrong or wants to challenge the company’s effort during review, they must act by August 15 or December 15, 2025.
Next: 2025-11041, Determination of Regulatory Review Period for Purposes of Patent Extension; ROLVEDON
The FDA has officially set the review period for ROLVEDON, a new medicine, so its patent can be extended. This helps the company protect their invention longer, giving them more time to make money before generics show up. If anyone thinks the dates are wrong or wants to challenge the company’s effort during review, they must speak up by August 15 or December 15, 2025.