Parenteral Iron Replacement Drug Class List

Drugs in Drug Class: Parenteral Iron Replacement

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes	10,179,120
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes	9,802,973		Y	Y
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes	9,248,148

Parenteral Iron Replacement Market Analysis and Financial Projection

The global parenteral iron replacement market is experiencing robust growth driven by rising chronic disease prevalence, aging populations, and therapeutic advancements. Valued at $3.53 billion in 2023, the intravenous (IV) iron drugs segment alone is projected to reach $8.19 billion by 2034 (8.8% CAGR) [7][12], while the broader IV/oral iron market could hit $16.34 billion by 2029 (13.47% CAGR) [1]. Below is an analysis of market dynamics and patent trends:

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Market Dynamics

Growth Drivers

• Chronic Disease Burden: Conditions like chronic kidney disease (CKD), cancer, and inflammatory bowel disease drive demand. CKD patients, for example, often require IV iron due to poor oral absorption, contributing to over $1 billion in segment revenue in 2023 [7][15].
• Aging Population: Older adults are more susceptible to iron deficiency anemia (IDA) due to comorbidities and malabsorption, with the geriatric demographic accounting for significant market share [7][15].
• Superior Efficacy of IV Iron: Non-compliance with oral therapy (30–70% rates) and rapid efficacy of IV formulations for severe IDA fuel adoption [5][13].
• Innovations in Formulations: Newer agents like ferric carboxymaltose (FCM) and ferumoxytol offer better safety profiles, faster infusions (e.g., 1-hour dosing), and higher single doses (up to 1,500 mg) [9][13].

Market Segmentation

• By Product: Ferric carboxymaltose dominates, projected to reach $1.5 billion by 2032 due to its safety and dosing convenience [15].
• By Application: CKD holds >50% market share, driven by high IDA prevalence in dialysis patients [7][15].
• By Region: North America leads (34% share), followed by Europe and Asia-Pacific. APAC’s growth (13.4% CAGR) reflects improving healthcare access and large IDA patient pools [1][12].

Regulatory and Payer Challenges

• Prior Authorization Policies: Insurers like United Healthcare and Cigna now require step therapy (oral iron first), delaying IV treatment despite FDA labels [9].
• Cost-Effectiveness: Newer IV irons (e.g., FCM) reduce hospitalization and total care costs by 20–30% compared to older formulations, per claims data [14].

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Patent Landscape

Key Patents and Expiries

• Ferric Carboxymaltose (Injectafer®): Protected by multiple U.S. patents (e.g., US7754702, US11433091) expiring in 2027–2028. Settlements with generics (e.g., Mylan, Sandoz) allow limited launches starting in 2028 [17][18].
• Ferumoxytol (Feraheme®): Patents expired in 2020–2023, though extensions in some regions (e.g., U.S. to June 2023) delayed generics [3].
• Formulation Innovations: Recent patents focus on high-dose stability (e.g., US11433091 for 0.6g elemental iron doses) and cardiovascular safety (WO2020144667A1 for atrial fibrillation prevention) [2][8].

Strategic Moves

• Expanded Indications: Companies seek label expansions (e.g., heart failure, postpartum anemia) to broaden patient eligibility [6][8].
• Geographic Expansion: Vifor introduced Ferinject® in China (2021), while Pharmacosmos targets emerging markets [1][6].
• Collaborations: Licensing deals (e.g., Vifor-Fresenius partnership) and patent settlements mitigate litigation risks [17].

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Competitive Landscape

• Top Players: Vifor Pharma, American Regent, AMAG Pharmaceuticals, and Pharmacosmos lead with >60% combined market share [1][5].
• Innovation Focus:
  • Nanoparticle Delivery: Enhances iron stability and reduces side effects [15].
  • Home Infusion Solutions: Companies like Emcure Pharmaceuticals target home healthcare with user-friendly formats (e.g., Orofer FCM 750) [4].

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Future Outlook

• Generics Impact: Post-2027, generic FCM and ferumoxytol could reduce prices by 30–50%, increasing accessibility [18].
• Technological Advances: Next-gen formulations (liposomal iron, dextran-free complexes) aim to further minimize hypersensitivity risks [13][15].
• Policy Advocacy: Medical societies push for payer policy reforms to align with clinical guidelines, emphasizing IV iron’s role in reducing hospitalizations [9].

"The renewal of the market lies in progressive leaps with treatments that mend the shortage of healthy red blood cells." [4]

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Key Takeaways

1. Parenteral iron demand is surging due to CKD and demographic shifts.
2. Patent cliffs post-2027 will reshape competition, favoring generics.
3. Regulatory and payer policies remain critical hurdles for market access.
4. Innovations in safety and dosing efficiency drive long-term growth.

FAQs
Q1: Why is IV iron preferred over oral therapy for CKD?
A: CKD patients often have gut inflammation, reducing oral iron absorption [7].

Q2: Which IV iron drug has the longest patent protection?
A: Ferric carboxymaltose (Injectafer®) patents expire in 2027–2028 [18].

Q3: How do newer IV irons reduce costs despite higher prices?
A: Fewer infusions and hospital visits offset drug costs, lowering total care expenses by ~25% [14].

Q4: What region offers the fastest growth for IV iron?
A: Asia-Pacific, driven by improving healthcare infrastructure and IDA prevalence [1][12].

Q5: Are IV iron drugs safe?
A: Modern formulations have severe adverse event rates of <1:200,000, surpassing older agents [13].

References

1. https://www.arizton.com/market-reports/iv-iron-oral-iron-drugs-market
2. https://pubchem.ncbi.nlm.nih.gov/patent/US11433091
3. https://www.globenewswire.com/news-release/2014/01/31/606396/10066344/en/AMAG-Pharmaceuticals-Announces-Issuance-of-New-U-S-Patent-for-Ferumoxytol.html
4. https://www.globenewswire.com/news-release/2024/01/24/2815974/28124/en/Global-Iron-Deficiency-Anemia-Therapy-Market-Analysis-2024-2034-Featuring-Profiles-of-Leading-Players-Including-AbbVie-Bayer-CSL-Vifor-Sanofi-and-Teoxane.html
5. https://www.verifiedmarketresearch.com/product/intravenous-iron-drugs-market/
6. https://straitsresearch.com/report/iv-and-oral-iron-drugs-market
7. https://www.precedenceresearch.com/intravenous-iron-drugs-market
8. https://patentimages.storage.googleapis.com/97/b6/0f/c07aab4380d27d/WO2020144667A1.pdf
9. https://oncpracticemanagement.com/issues/2022/february-2022-vol-12-no-2/2775-new-policies-regardingintravenous-iron-replacement-are-creating-conundrum-for-providers-and-payers
10. https://www.skyquestt.com/report/intravenous-iron-drugs-market
11. https://www.cda-amc.ca/sites/default/files/es/es0338_international-policies-on-parental-iron-es.pdf
12. https://www.biospace.com/intravenous-iron-drugs-market-size-to-worth-around-us-7-41-billion-by-2033
13. https://haematologica.org/article/view/7396
14. https://www.jmcp.org/doi/full/10.18553/jmcp.2023.22407
15. https://www.gminsights.com/industry-analysis/intravenous-iron-drugs-market
16. https://patents.google.com/patent/US3686397A/en
17. https://www.businesswire.com/news/home/20211219005059/en/Vifor-Pharma-and-American-Regent-announce-settlement-of-Injectafer%C2%AE-patent-litigation
18. https://pharsight.greyb.com/drug/injectafer-patent-expiration