FDA Sets Review Clock for KEBILIDI Drug Patent Extension Purposes
Published Date: 2/13/2026
Notice
Summary
The FDA has set the official review period for KEBILIDI, a human biological product, so its patent holder can apply for extra patent time. This helps the company protect their invention longer, potentially affecting when generic versions can enter the market. If anyone thinks the dates are wrong or the company wasn’t diligent, they have until April or August 2026 to speak up.
Analyzed Economic Effects
5 provisions identified: 3 benefits, 1 costs, 1 mixed.
FDA Sets 1,612-Day Review Period
The FDA determined the regulatory review period for KEBILIDI is 1,612 days in total, with 1,368 days in the testing phase and 244 days in the approval phase. This determination establishes the maximum potential length of a patent extension that the patent holder may seek from the USPTO.
Applicant Requests Specific Extension Days
In its patent extension application to the USPTO, the applicant for KEBILIDI seeks either 277 days or 816 days of patent term extension. The USPTO will apply statutory limitations when calculating any actual extension.
Possible Delay to Generic Market Entry
The FDA notice states the determination lets the patent holder apply for extra patent time, which can protect the invention longer and potentially affect when generic versions can enter the market. That timing can influence when patients and purchasers may see generic alternatives.
FDA Identifies Key IND/BLA Dates
FDA records show the IND effective date for KEBILIDI was June 17, 2020 (the applicant claimed March 29, 2020), the biologics license application was initially submitted on March 15, 2024, and the application was approved on November 13, 2024. These specific dates were used to derive the testing and approval phase lengths that underlie the regulatory review period.
Deadlines to Challenge Dates or Diligence
Anyone who believes the published dates are incorrect must ask for a redetermination by April 14, 2026. Any interested person may petition FDA regarding whether the applicant acted with due diligence during the regulatory review period by August 12, 2026.
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.
2026-20730, Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction
The FDA fixed a previous announcement about pulling approval for 16 generic drug applications. Three drugs from Navinta LLC—ribavirin solution, fosaprepitant powder, and nicardipine capsules—won't lose approval because Navinta asked to keep them active. This means those three drugs stay on the market, while the other 13 still had their approvals withdrawn as planned back in July 2026.
Previous / Next Documents
Previous: 2026-02974, Determination of Regulatory Review Period for Purposes of Patent Extension; AMTAGVI
The FDA has officially set the review period for AMTAGVI, a new human biological product, so its patent can be extended. This affects the company behind AMTAGVI and anyone interested in patent timing or drug availability. If you think the dates are wrong or want to challenge the company’s diligence, you have until April 14 or August 12, 2026, to speak up—so don’t miss these deadlines!
Next: 2026-02977, Agency Forms Submitted for OMB Review, Request for Comments
The Railroad Retirement Board is asking for public feedback on forms used to prove marriage status for railroad benefits. They want to make sure the forms are clear, useful, and not too much work to fill out. If you’re involved in railroad benefits, your input can help shape these forms—comments are due within 30 days, so don’t miss out!