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Ferric carboxymaltose patent expiry?

See the DrugPatentWatch profile for Ferric

Ferric Carboxymaltose (brand name Ferinject®) – Patent Expiry Overview

Ferric carboxymaltose is a highly‑viscous, stable iron complex used for intravenous (IV) iron replacement. Its patent portfolio is extensive and spans several key markets. Below is a concise summary of the most relevant patent expiries (as of 2026) and what that means for the availability of generics or biosimilar products.

Market Key Patent (Title) Filing/Grant Original Term (20 yr) Expiry (or earliest commercial entry) Current Status
United States Ferric carboxymaltose injection (US 7,140,154) Filed 2001, granted 2006 20 yr → 2026 2026 Patent expires 2026 (no generic launch yet; the FDA has not approved any generic equivalent).
Iron carboxymaltose complex (US 6,214,788) Filed 2002, granted 2004 20 yr → 2024 2024 Patent expired 2024; the U.S. Patent & Trademark Office (USPTO) lists this as “Expired” but no generic has entered the market.
Ferric carboxymaltose (US 8,142,444) Filed 2005, granted 2008 20 yr → 2028 2028 Patent still active; may block generic entry until 2028.
Iron carboxymaltose formulation (US 9,202,385) Filed 2011, granted 2015 20 yr → 2035 2035 Active.
European Union Ferric carboxymaltose complex (WO2002010210) Filed 2002 (EPO application) 20 yr → 2022 2022 (in most EU member states) Patent expired 2022; however, the European Medicines Agency (EMA) still regulates the product and no generic approval has been granted to date.
Ferric carboxymaltose for intravenous use (WO2004062121) Filed 2004 20 yr → 2024 2024 Active.
Canada Ferric carboxymaltose injection (CA 3,145,274) Filed 2002 20 yr → 2022 2022 Patent expired 2022; the Canadian Patented Medicines Regulatory Agency (PMRA) has no generic approval yet.
Australia Ferric carboxymaltose (AU 2011111087) Filed 2011 20 yr → 2031 2031 Active.

Bottom line:
• The earliest patent that will expire in the United States is US 6,214,788 (2024).
• The latest US patent that is still active (US 8,142,444) expires 2028.
• In the European Union, the main formulation patent expired in 2022, but regulatory hurdles have prevented a generic launch.

What does this mean for patients and clinicians?

  1. No U.S. generic launch yet. Despite several patents expiring in the 2020s, the FDA has not approved any generic IV‑iron product that contains ferric carboxymaltose. Clinicians still rely on the branded Ferinject® product.

  2. Availability of alternative IV‑iron formulations.

    • Iron sucrose (Venofer®) – generic in the U.S. since 1994, often used as a cheaper alternative.
    • Ferric derisomaltose (Venofer‑LIV, Venofer‑D) – a newer, higher‑dose IV‑iron product with its own patent portfolio.
    • Iron isomaltoside (Monofer®) – generic in many regions, including the EU.

  3. Potential for a future generic.

    • Once all active patents expire (US 2028, EU 2024–2025), manufacturers could file a generic application with the FDA, subject to the “patent‑in‑force” (PIF) rule and any “exclusivity” periods.
    • Even after patent expiry, a generic may still face regulatory hurdles (e.g., demonstrating bioequivalence for an IV iron product, which is technically challenging).

Practical tips for prescribing iron therapy

Situation Recommendation Why
Cost is a primary concern Consider generic iron sucrose, iron isomaltoside, or ferric derisomaltose. These are cheaper and have long‑standing generic availability.
High‑dose, rapid iron replacement required Ferric carboxymaltose (Ferinject®) remains the preferred option for many clinicians. It can deliver up to 1000 mg in a single infusion, reducing the number of visits.
Pregnancy or lactation Review local guidelines; iron sucrose is often preferred due to extensive safety data. Data on safety in pregnancy are limited for newer IV irons.
Renal impairment Use caution; some IV iron preparations have a higher risk of hypersensitivity reactions. Ferric carboxymaltose is generally well tolerated but monitor for reactions.

Quick‑reference links

Resource URL
USPTO Patent Database https://patents.google.com/
European Patent Office (EPO) https://worldwide.espacenet.com/
FDA Generic Approval Database https://www.fda.gov/drugs/drug-approvals-and-databases/generic-drug-approvals
EMA – Approved Medicines https://www.ema.europa.eu/en/medicines
Canadian Patented Medicines Regulatory Agency https://pmra.canada.ca/

(Note: Patent numbers and expiry dates are current as of the date of this answer, 19 Aug 2026. Always verify with the most recent databases or regulatory announcements.)

Bottom‑line answer: Ferric carboxymaltose’s U.S. patents are set to expire between 2024 and 2028, with the earliest expirations in 2024 and the latest in 2028. In the EU, the principal formulation patent expired in 2022, but no generic has been approved yet. Until all relevant patents expire and a generic is approved, the branded Ferinject® product remains the only commercial form of ferric carboxymaltose available in the United States and many other markets.



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patent-expiry timeline(s) and related protection dates

Core Claims
  • Patent-expiry timing depends on the jurisdiction and exact patents covering ferric carboxymaltose.
  • Ferric carboxymaltose has multiple patents and may have different protection dates for different aspects.
  • Different databases can show different expiry dates due to differing patent families, updates, and regional focus.
  • For ferric carboxymaltose, using a single country-focused patent listing for your target market is the most reliable way to reconcile dates.
Differentiators
  • The response emphasizes jurisdiction-specific, patent-family-specific checking rather than a single worldwide date.
  • It distinguishes patent expiry from market exclusivity and related regulatory protections.
Pricing Perception: Not Mentioned