FDA's POMBILITI Review Timeline Could Extend Drugmaker's Patent Exclusivity
Published Date: 6/16/2025
Notice
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.
Analyzed Economic Effects
4 provisions identified: 3 benefits, 0 costs, 1 mixed.
FDA sets POMBILITI review period length
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 29, 2021; and the BLA was approved September 28, 2023. This determination establishes the maximum potential length that can be considered for patent term extension.
Applicant seeks 729 days of patent extension
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 statutory limitations in computing the actual extension.
FDA confirms IND effective date (Dec 20, 2015)
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.
Deadlines to challenge dates or diligence
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. The docket number for comments is FDA-2024-E-0847; petitions have requirements under 21 CFR 60.30.
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