Determination of Regulatory Review Period for Purposes of Patent Extension; INJECTAFER
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The FDA has calculated the regulatory review period for Injectafer (ferric carboxymaltose), used to treat iron deficiency anemia in adults intolerant or unresponsive to oral iron with non-dialysis dependent chronic kidney disease. The total regulatory review period is 3,450 days, consisting of an 853-day testing phase and a 2,597-day approval phase. Key dates are: IND effective February 15, 2004; NDA submitted June 16, 2006; and FDA approval on July 25, 2013. This determination sets the maximum possible patent term extension for U.S. Patent No. 7,612,109. The applicant is seeking 1,267 days of extension. Comments on the accuracy of dates must be submitted by June 2, 2026, and petitions regarding due diligence by September 30, 2026.
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Key Changes
- FDA determined total regulatory review period for Injectafer as 3,450 days
- Testing phase: 853 days (effective IND date February 15, 2004)
- Approval phase: 2,597 days (NDA submitted June 16, 2006; approved July 25, 2013)
+ 3 more changes with Pro
Obligations
What this law requires
Submit comments regarding the accuracy of dates (IND effective date: February 15, 2004; NDA submission date: June 16, 2006; FDA approval date: July 25, 2013) by June 2, 2026, via regulations.gov or written submission to FDA Dockets Management Staff
Submit petitions regarding whether the applicant for patent extension acted with due diligence during the regulatory review period by September 30, 2026
Include Docket No. FDA-2014-E-2328 in all submissions related to the INJECTAFER regulatory review period determination
For confidential submissions, submit written/paper comments only (two copies total) with one copy marked 'THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION' and the second copy with confidential information redacted for public viewing
Ensure electronic comments are submitted via https://www.regulations.gov by 11:59 p.m. Eastern Time on June 2, 2026, and mail/hand delivery comments are received on or before that date