INJECTAFER Patent Gets FDA's Official Timeline Nod
Published Date: 4/3/2026
Notice
Summary
The FDA has officially set the review period for INJECTAFER, a drug patent up for extension. This means the company can apply to extend their patent protection, potentially keeping their exclusive rights longer and impacting competition and pricing. If anyone thinks the dates are wrong or the company wasn’t diligent, they can speak up by June 2 or September 30, 2026.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 1 costs, 1 mixed.
INJECTAFER patent review period set
The FDA found the regulatory review period for INJECTAFER is 3,450 days in total — 853 days in the testing phase and 2,597 days in the approval phase. This determination establishes the maximum potential length of a patent extension; the applicant (Vifor International AG, U.S. Patent No. 7,612,109) seeks 1,267 days of patent term extension. Key dates used: IND effective February 15, 2004; NDA submitted June 16, 2006; FDA approval July 25, 2013.
Deadlines to challenge dates and diligence
If you think the published dates are wrong, you may submit electronic or written comments and ask for a redetermination by June 2, 2026. Any interested person may petition FDA by September 30, 2026 to challenge whether the applicant acted with due diligence during the regulatory review period.
Statutory cap: patent extensions up to 5 years
Under the Drug Price Competition and Patent Term Restoration Act and related law, a patent may be extended for a period of up to 5 years when the patented product was subject to FDA regulatory review before marketing. FDA's regulatory review-period determination is used to calculate the maximum potential extension, while the USPTO applies statutory limitations when awarding the actual extension.
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Key Dates
Department and Agencies
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