FDA Sets Timeline for BLUJEPA Drug Patent Extension
Published Date: 2/13/2026
Notice
Summary
The FDA has officially set the review period for BLUJEPA, a human drug, which helps the company extend its patent protection. This means the drug maker could get more time to exclusively sell BLUJEPA, potentially affecting competition and profits. If anyone thinks the dates are wrong or the company wasn’t diligent, they can speak up by April 14 or August 12, 2026.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 0 costs, 1 mixed.
FDA Sets Patent Review Period
The FDA determined BLUJEPA's regulatory review period is 4,948 days total — 4,705 days in the testing phase and 243 days in the approval phase. Key dates are: IND effective September 9, 2011; NDA submitted July 26, 2024; and NDA approved March 25, 2025. The applicant is seeking 5 years of patent extension, and FDA's determination establishes the maximum potential length of a patent extension for BLUJEPA.
Opportunity to Challenge Dates
Anyone who believes the published dates are wrong may ask FDA for a redetermination by April 14, 2026. Any interested person may petition FDA about whether the applicant acted with due diligence during the regulatory review period by August 12, 2026, following the procedural rules cited in the notice.
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.
2025-04978, 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.
2026-20063, Request for Nominations for Voting Members of Food and Drug Administration Advisory Committees
The FDA is looking for smart, qualified people to join its advisory committees and help make important decisions about food and drugs. If you have the right skills, you can apply anytime, but get your nomination in by November 30, 2026, for the best chance at current openings. This is a great chance to influence public health without any cost to you!
Previous / Next Documents
Previous: 2026-02900, Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Its Price List
The New York Stock Exchange is updating its price list starting February 2, 2026. They’re giving monthly rebates to Designated Market Makers for IPOs and transfers, and changing fees for sending certain stock orders to Nasdaq. Traders and market makers will feel the impact with these fresh fee tweaks designed to keep things fair and competitive.
Next: 2026-02902, John Bender, M.D.; Decision and Order
Dr. John Bender from Fort Collins, Florida, had his DEA registration suspended and is now facing revocation because he filled over 4,200 controlled substance prescriptions without the proper pharmacy licenses. This decision protects public health by shutting down unregistered pharmacies operating at his clinics. The changes take effect immediately, impacting Dr. Bender’s ability to legally handle controlled substances and signaling serious legal and financial consequences.