FDA Clocks Time for Drug Patent Party Extension
Published Date: 10/9/2026
Notice
Summary
The FDA has officially set the review period for MONOFERRIC, a human drug, which helps the company extend its patent protection. This means the drug maker could get extra time to keep their invention exclusive, potentially affecting competition and market prices. If anyone thinks the dates are wrong or wants to challenge the company’s diligence, they have until late 2026 or early 2027 to speak up.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
FDA sets MONOFERRIC review period, patent extension sought
FDA determined the regulatory review period for MONOFERRIC is 3,292 days total: 2,990 days in the testing phase and 302 days in the approval phase. The drugmaker (Pharmacosmos) has applied for a patent term extension and is seeking 1,136 days of additional patent protection; the U.S. Patent and Trademark Office will apply statutory limits when calculating the actual extension. This determination establishes the maximum potential extension and could let the company keep exclusive rights for additional years, which may affect competition and market prices.
Deadlines to challenge MONOFERRIC dates or diligence
Anyone who believes the published dates are incorrect may submit comments asking for a redetermination by December 8, 2026. Any interested person may petition FDA to challenge whether the applicant acted with due diligence during the regulatory review period by April 7, 2027, following the procedures in 21 CFR 60.24 and 60.30.
MONOFERRIC approved for specific anemia patients
FDA approved MONOFERRIC (ferric derisomaltose) for treating iron deficiency anemia in adults who cannot tolerate oral iron or had an unsatisfactory response to oral iron, and for adults with non-hemodialysis dependent chronic kidney disease; the new drug application (NDA 208171) was initially submitted on March 21, 2019 and approved on January 16, 2020. This notice confirms the product’s approved indications and the dates used to calculate the regulatory review period.
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