# 2025-11025: FDA's POMBILITI Review Timeline Could Extend Drugmaker's Patent Exclusivity 2025-11025, Determination of Regulatory Review Period for Purposes of Patent Extension; POMBILITI, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-06-16, effective Comments must be submitted by August 15, 2025. Petitions regarding whether the applicant acted with due diligence must be filed by December 15, 2025. (as of 2026-11-02). - Canonical: https://policyrisk.com/federal-register/2025-11025 - As of: 2026-11-02 - Plain-text twin of the page above; the HTML and this file carry the same facts. ## Facts - Document number: 2025-11025 - Title: Determination of Regulatory Review Period for Purposes of Patent Extension; POMBILITI - Type: Notice - Agencies: Health and Human Services Department; Food and Drug Administration - Citation: 90 FR 25338 - Published: 2025-06-16 - Effective: Comments must be submitted by August 15, 2025. Petitions regarding whether the applicant acted with due diligence must be filed by December 15, 2025. - Comments close: not stated - Significant: no - Touches household money: no - Regulation identifier numbers: none - Last updated: 2026-11-02 ## In one line FDA's POMBILITI Review Timeline Could Extend Drugmaker's Patent Exclusivity ## Summary The FDA has set the official review period for the drug POMBILITI, which helps the company extend its patent protection. This means the drug maker can get extra time to keep exclusive rights, potentially boosting their profits. If anyone thinks the dates are wrong or wants to challenge the company’s effort during review, they must act by mid or late 2025. ## Abstract The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for POMBILITI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product. ## Effects PRIA read - FDA sets POMBILITI review period length: benefit, high. The FDA determined the regulatory review period for POMBILITI is 2,841 days in total: 2,049 days for the testing phase and 792 days for the approval phase. FDA verified the key dates used: the IND became effective December 20, 2015; the biologics license application (BLA B761204) was submitted July… - FDA confirms IND effective date (Dec 20, 2015): mixed, low. FDA records show the investigational new drug (IND) for POMBILITI became effective on December 20, 2015, while the applicant claimed December 30, 2015. FDA states December 20, 2015 was the first date after receipt when investigational studies were allowed to proceed. - Applicant seeks 729 days of patent extension: benefit, high. Amicus Therapeutics has applied to the U.S. Patent and Trademark Office seeking 729 days of patent term extension for U.S. Patent No. 10,208,299 covering POMBILITI. FDA notes that its regulatory review period determination establishes the maximum potential extension, while the USPTO will apply stat… - Deadlines to challenge dates or diligence: benefit, low. Anyone who believes the published dates are incorrect must submit comments and ask for a redetermination by August 15, 2025. Any interested person may petition FDA for a determination about whether the applicant acted with due diligence during the regulatory review period by December 15, 2025. 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