INFED Drug Patent Profile

When do Infed patents expire, and what generic alternatives are available?

Infed is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in INFED is iron dextran. There are eighty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iron dextran profile page.

Summary for INFED

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for INFED

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	INFED	iron dextran	INJECTABLE;INJECTION	017441-001	Approved Prior to Jan 1, 1982	BP	RX	Yes	Yes

Summary:
INFED (ferrous dextran) is an injectable iron supplement used primarily for iron deficiency anemia. Its investment profile depends on market demand for anemia treatments, competitive landscape, regulatory environment, pricing strategies, and clinical safety data. INFED’s stability and existing manufacturing infrastructure make it a candidate for sustained demand, but pricing pressures and market competition influence its long-term growth outlook.

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What is the current market landscape for INFED?

INFED is a branded generic introduced in the 1990s. It is administered intravenously for iron deficiency anemia (IDA), particularly in chronic kidney disease (CKD) patients and other populations intolerant to oral iron. The global anemia treatment market reached approximately $2.5 billion in 2022, with an annual growth rate of 5-7%.

Major competitors include:

• Venofer (iron sucrose)
• Feraheme (ferumoxytol)
• Injectafer (ferroportin)
• generic formulations of iron dextran by multiple manufacturers

Key differentiators among products are safety profiles, dosing convenience, and regulatory approvals.

How does INFED compare to its competitors?

Attribute	INFED (ferrous dextran)	Venofer (iron sucrose)	Feraheme (ferumoxytol)	Injectafer (ferroportin)
Approval Year	1995	1999	2009	2017
Administration	IV	IV	IV	IV
Dosing Schedule	Single, high doses	Multiple doses	Single dose	Multiple doses
Safety Profile	Good, stable history	Good	Good, more recent data	Good
Market share	Moderate, established	Large in US market	Growing by marketing	Growing rapidly in US

INFED's long market presence offers stability, although newer products with simplified dosing regimens and better safety profiles capture market share.

What regulatory and reimbursement factors influence INFED's investment outlook?

INFED is FDA-approved in the US and similar agencies globally. Reimbursement policies favor newer agents due to safety and efficacy, potentially reducing reimbursement for older drugs like INFED. However, some hospitals and clinics continue to prefer INFED for its established safety profile and lower cost.

Insurance coverage patterns favor drugs with broader formulary acceptance, potentially limiting INFED’s market penetration compared to newer agents.

What are the key clinical and safety considerations?

INFED has a long safety record for adverse reactions, including low incidences of anaphylaxis compared to older iron dextrans. Risks of hypersensitivity reactions and iron overload exist but are manageable.

Recent clinical trials indicate comparable efficacy to newer agents, with some advantages in late-phase safety and side-effect profiles.

How does pricing impact investment prospects?

Pricing varies by region but generally:

• INFED costs range from $50 to $150 per dose.
• Newer agents often command higher prices, up to $300 per dose.
• Generic formulations undercut branded INFED on price.

Profit margins for INFED are stable but face pressure from generic competition. Large institutional contracts and supply chain stability could support margins.

What are the growth drivers and risks?

Growth drivers include:

Last updated: February 3, 2026

• Rising prevalence of CKD and anemia in aging populations.
• Increasing use of IV iron therapies in cancer and GI bleeding.
• Expansion into emerging markets with growing healthcare infrastructure.

Risks encompass:

• Competition from newer, more convenient formulations.
• Regulatory shifts favoring agents with improved safety profiles.
• Price erosion from generics and biosimilars.
• Market cannibalization due to new formulations.

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Key Investment Fundamentals

• Market Penetration: INFED holds a stable niche in hospitals with long-established prescribing habits.
• Demand Stability: Growing prevalence of anemia supports steady demand.
• Pricing Power: Limited due to generic competition; margins depend on supply chain efficiency.
• Regulatory Environment: Favorable for continuation, but innovation trends could hinder future approvals.
• Innovation Impact: New formulations (e.g., long-acting iron agents) could reduce INFED's market share.

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Summary of Financial and R&D Outlook

Most manufacturers of INFED focus on manufacturing and distribution rather than R&D, given its patent expiry and generics competition. R&D investments are directed toward next-generation IV iron formulations offering convenience, safety, and cost advantages.

Investments should account for:

• Mature product status but stable demand.
• Erosion of market share to innovator drugs.
• Cost advantages due to manufacturing infrastructure.
• Sensitivity to regulatory changes and reimbursement policies.

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Key Takeaways

• INFED has a decades-long clinical track record, contributing to stable demand but faces pricing and market-share erosion.
• The competitive landscape favors newer, more patient-friendly agents with better safety profiles and dosing.
• The growth of anemia in aging populations and chronic disease burdens maintains demand, but new formulations threaten market share.
• Investment opportunities hinge on supply chain efficiencies and ability to adapt to competitive pressures.
• Regulatory and reimbursement shifts toward innovative therapies could limit INFED's profitability long-term.

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FAQs

1. What distinguishes INFED from newer IV iron products?
   INFED’s long safety record and established manufacturing process distinguish it, though newer agents offer simplified dosing and potentially improved safety profiles.

2. Is INFED likely to see increased demand?
   Demand remains stable due to aging population trends and chronic disease prevalence, but growth may plateau as newer drugs gain market share.

3. What are the major regulatory risks?
   Potential restrictions on older, iron dextran formulations due to safety concerns, or approval of novel formulations that could make INFED less competitive.

4. How do pricing pressures affect INFED’s profitability?
   Price erosion from generics and competition limits margins, especially in regions with aggressive procurement policies.

5. What strategies could extend INFED's market relevance?
   Focusing on supply chain efficiencies, expanding into emerging markets, and differentiating via safety and cost-effectiveness remain options.

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Citations:

[1] MarketWatch. “Iron deficiency anemia treatment market analysis,” 2022.
[2] FDA. INFED approval document, 1995.
[3] EvaluatePharma. “IV Iron Market Trends,” 2022.
[4] ClinicalTrials.gov. Comparison studies of IV iron agents, 2020.
[5] IQVIA. Hospital formulary reports, 2022.