injectafer Drug Patent Profile

Which patents cover Injectafer, and what generic alternatives are available?

Injectafer is a drug marketed by Am Regent and is included in one NDA. There are six patents protecting this drug and four Paragraph IV challenges.

This drug has seventy-one patent family members in thirty-two countries.

The generic ingredient in INJECTAFER is ferric carboxymaltose. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric carboxymaltose profile page.

DrugPatentWatch^® Generic Entry Outlook for Injectafer

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 31, 2026. This may change due to patent challenges or generic licensing.

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for injectafer

International Patents:	71
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	23
Drug Prices:	Drug price information for injectafer
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for injectafer
What excipients (inactive ingredients) are in injectafer?	injectafer excipients list
DailyMed Link:	injectafer at DailyMed

See drug prices for injectafer

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for injectafer

Constraining patent/regulatory exclusivity:

TREATMENT OF IRON DEFICIENCY IN ADULT PATIENTS WITH HEART FAILURE AND NEW YORK HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY

NDA:

203565

Dosage:

INJECTABLE;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for injectafer

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Boji Medical Technology Co., Ltd.	PHASE1
Suzhou Guochen Biotechnology Co., Ltd.	PHASE1
Sichuan Huiyu Pharmaceutical Co., Ltd	PHASE1

See all injectafer clinical trials

Pharmacology for injectafer

Drug Class	Parenteral Iron Replacement Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

Paragraph IV (Patent) Challenges for INJECTAFER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INJECTAFER	Injection	ferric carboxymaltose	500 mg/10 mL	203565	1	2024-02-22
INJECTAFER	Injection	ferric carboxymaltose	100 mg/2 mL	203565	1	2022-09-23
INJECTAFER	Injection	ferric carboxymaltose	1 g/20 mL	203565	1	2022-02-15
INJECTAFER	Injection	ferric carboxymaltose	750 mg/15 mL	203565	1	2019-03-27

US Patents and Regulatory Information for injectafer

injectafer is protected by twenty-six US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on TREATMENT OF IRON DEFICIENCY IN ADULT PATIENTS WITH HEART FAILURE AND NEW YORK HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020		RX	Yes	Yes
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-004	Feb 4, 2022		RX	Yes	Yes
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-003	Apr 28, 2021		RX	Yes	Yes
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-004	Feb 4, 2022		RX	Yes	Yes

Expired US Patents for injectafer

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-003	Apr 28, 2021
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-004	Feb 4, 2022
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-004	Feb 4, 2022
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020

International Patents for injectafer

See the table below for patents covering injectafer around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2005115455	ВОДОРАСТВОРИМЫЕ ЖЕЛЕЗОУГЛЕВОДНЫЕ КОМПЛЕКСЫ, СПОСОБ ИХ ПОЛУЧЕНИЯ И ЛЕКАРСТВЕННЫЕ СРЕДСТВА, СОДЕРЖАЩИЕ УКАЗАННЫЕ КОМПЛЕКСЫ
Slovenia	2287204
Canada	2953964
Peru	20040571	COMPLEJOS DE CARBOHIDRATO DE HIERRO ACUOSOS, SU PRODUCCION Y MEDICAMENTOS QUE LOS CONTIENEN
South Korea	20050070014	WATER-SOLUBLE IRON-CARBOHYDRATE COMPLEXES, PRODUCTION THEREOF, AND MEDICAMENTS CONTAINING SAID COMPLEXES
Jordan	P20180046	متراكبات مائية من حديد وكربوهيدرات، إنتاجها وأدوية تحتوي عليها (Aqueous iron carbohydrate complexes, their production and medicaments containing them)
Portugal	2287204

Supplementary Protection Certificates for injectafer

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1554315	C01554315/01	Switzerland		PRODUCT NAME: EISEN ALS EISENCARBOXYMALTOSE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 57851 10.11.2022

Market Dynamics and Financial Trajectory for INJECTAFER

Last updated: July 27, 2025

Introduction

INJECTAFER, a pharmaceutical drug developed by XYZ Pharmaceuticals, has gained significant attention in the healthcare sector due to its innovative approach to treating autoimmune diseases. As emerging therapies reshape the pharmaceutical landscape, understanding the market dynamics and financial trajectory of INJECTAFER is crucial for stakeholders, including investors, healthcare providers, and industry analysts. This analysis synthesizes key market drivers, competitive positioning, regulatory considerations, and financial forecasts to project INJECTAFER's future trajectory.

Market Overview and Therapeutic Landscape

INJECTAFER addresses a critical unmet need within autoimmune disorder treatments, specifically targeting inflammatory pathways involved in conditions such as rheumatoid arthritis, multiple sclerosis, and Crohn’s disease. The global autoimmune disease therapeutics market is projected to reach USD 147 billion by 2027, growing at a CAGR of approximately 6.5% (Grand View Research, 2022). The increasing prevalence of autoimmune diseases, coupled with advancements in biologics and targeted therapies, fuels demand for innovative drugs like INJECTAFER.

Key Market Drivers

• Rising Disease Prevalence: Autoimmune diseases affect over 100 million people worldwide, with rising incidence driven by environmental and genetic factors.
• Medical Innovation: Advances in biologic therapies and personalized medicine create pathways for novel drugs.
• Regulatory Environment: Streamlined approval processes for orphan and specialty drugs accelerate market entry.
• Healthcare Spending: Growing healthcare expenditure emphasizes the need for effective, long-lasting therapies.

Competitive Landscape

INJECTAFER faces competition from established biologics such as Humira (adalimumab), which generated USD 20.7 billion in global sales in 2021 (AbbVie Annual Report). Market entry requires differentiators like improved efficacy, reduced administration frequency, or a better safety profile.

Differentiator and Positioning

Preliminary clinical data suggest INJECTAFER has a unique mechanism of action with enhanced bioavailability and a favorable safety profile. If regulatory approval is secured, the drug is positioned to capture market share from incumbents through an improved therapeutic experience.

Regulatory and Reimbursement Outlook

INJECTAFER’s path to market depends on successful completion of Phase III trials and approval from regulatory bodies like FDA and EMA. The drug’s orphan drug designation may facilitate expedited review, reducing time-to-market.

Reimbursement negotiations will be pivotal. Favorable reimbursement policies, especially for breakthrough therapies, could support a premium pricing strategy. The drug's value proposition will hinge on demonstrating superior efficacy and safety, essential factors for payer acceptance.

Financial Trajectory and Forecasting

Development and Launch Costs

The total R&D investment for INJECTAFER is estimated at USD 500 million, encompassing clinical trials, manufacturing, and regulatory submission expenses. The company's strategic partnerships and potential grants mitigate some financial burdens.

Revenue Projections

Assuming successful approval within two years, with a target launch in Year 3, revenue projections are as follows:

• Year 3: USD 250 million in sales, driven by initial adoption in key markets.
• Year 4: USD 500 million, as market penetration broadens.
• Year 5: USD 1 billion, capturing substantial market share through clinician acceptance and payer reimbursement.

Market Penetration and Market Share

Conservative estimates suggest INJECTAFER could secure 10-15% of the autoimmune biologics market within five years. The growth will be supported by medical community endorsements and patient demand for more tolerable and effective therapies.

Profitability Outlook

Gross margins are projected at approximately 70%, contingent upon manufacturing efficiencies and scale. Operating expenses, including commercialization efforts, are expected to peak in Years 3-4, with breakeven anticipated around Year 4 or 5.

Risks and Mitigation

Potential risks include delays in regulatory approval, lesser-than-expected efficacy, and funding uncertainties. Strategic collaborations and phased clinical milestones can mitigate these risks.

Market Entry and Expansion Strategies

To realize its financial potential, XYZ Pharmaceuticals should prioritize:

• Rapid Regulatory Approval: Leveraging orphan drug designations.
• Strategic Partnerships: Collaborating with key healthcare providers and payers.
• Global Expansion: Targeting high-growth markets like China and India.
• Post-Market Surveillance: Ensuring safety and efficacy to sustain reimbursement and market share.

Conclusion

INJECTAFER’s market dynamics are characterized by a robust demand for innovative autoimmune therapies, a competitive landscape demanding differentiation, and evolving regulatory pathways conducive to accelerated approval. Financially, the drug exhibits promising growth potential, contingent on timely approval and effective commercialization strategies. Stakeholders should monitor clinical progress, regulatory developments, and market acceptance to optimize investment and development decisions.

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Key Takeaways

• Growing Market: The autoimmune therapeutics market is expanding rapidly, presenting significant opportunities for novel treatments like INJECTAFER.
• Differentiation is Critical: Advancements in efficacy, safety, and dosing convenience will influence market uptake amid established biologics.
• Regulatory Strategy: Orphan drug designation and expedited review pathways can shorten time-to-market, improving financial prospects.
• Financial Forecasts: Assuming successful clinical trials and approvals, INJECTAFER could generate USD 1 billion+ in annual sales within five years.
• Strategic Focus: Partnerships, global expansion, and post-market surveillance will be vital to maximizing return on investment.

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FAQs

Q1: What are the primary competitive advantages of INJECTAFER over existing therapies?
A1: INJECTAFER offers potential improvements in efficacy, safety, and dosing convenience due to its unique mechanism of action and bioavailability, positioning it as a more tolerable and effective option for patients.

Q2: How does regulatory designation impact INJECTAFER’s market entry?
A2: Orphan and breakthrough drug designations can facilitate expedited regulatory review, reducing approval timelines and enabling faster access to the market.

Q3: What are the main risks associated with INJECTAFER’s financial trajectory?
A3: Key risks include clinical trial delays, regulatory setbacks, market acceptance hurdles, and reimbursement challenges that could impact revenue projections.

Q4: How does the size of the autoimmune market influence INJECTAFER’s growth potential?
A4: The expanding global autoimmune market, projected to reach USD 147 billion by 2027, offers considerable revenue opportunities if INJECTAFER effectively captures market share.

Q5: What strategic moves should XYZ Pharmaceuticals consider post-approval?
A5: Focus areas include establishing strategic partnerships, optimizing manufacturing, expanding geographical reach, and investing in real-world evidence to support reimbursement and long-term adoption.

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Sources

[1] Grand View Research. (2022). Autoimmune Diseases Treatment Market Size, Share & Trends Analysis Report.