Federal Register #2026-20766

FDA Determines MONOFERRIC Regulatory Review Period for Patent Extension

This FDA notice concerns the patent-extension review for MONOFERRIC, not a government purchase. - Government agency: U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA). - Notice subject: FDA determined the regulatory review period for MONOFERRIC (ferric derisomaltose), an iron replacement drug for certain adults with iron deficiency anemia or non-hemodialysis-dependent chronic kidney disease. - Company named: Pharmacosmos Holding A/S is identified as the patent-extension applicant; the notice does not identify a procurement vendor. - Review findings: The total regulatory review period is 3,292 days: 2,990 testing-phase days and 302 approval-phase days. The applicant seeks a 1,136-day patent term extension. - Procurement status: This is not a solicitation or purchase request. No products or services, part numbers, quantities, contract value, or performance period are specified.

Description

The Food and Drug Administration determined the regulatory review period for MONOFERRIC (ferric derisomaltose) in connection with a patent-extension application. MONOFERRIC is an iron replacement product indicated for treatment of iron deficiency anemia in adults with intolerance or an unsatisfactory response to oral iron, and adults with non-hemodialysis-dependent chronic kidney disease. FDA determined the review period was 3,292 days: 2,990 days in the testing phase and 302 days in the approval phase. The notice allows requests to redetermine published dates by December 8, 2026, and petitions concerning due diligence by April 7, 2027.

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