INFED Drug Patent Profile

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Which patents cover Infed, 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 is one drug master file entry 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
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	33
Drug Prices:	Drug price information for INFED
What excipients (inactive ingredients) are in INFED?	INFED excipients list
DailyMed Link:	INFED at DailyMed

See drug prices for INFED

Pharmacology for INFED

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

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

INFeD (Iron Dextran) Market Dynamics, Patent Status, and Financial Trajectory

Last updated: October 15, 2026

INFeD is a mature injectable iron product with limited patent protection, no meaningful remaining regulatory exclusivity, and no publicly reported product-level revenue. Its commercial value depends on hospital and specialty-pharmacy demand, supply reliability, acquisition cost, reimbursement, and physician tolerance for its hypersensitivity risk. The product faces competition from iron sucrose, ferric carboxymaltose, ferumoxytol, ferric derisomaltose, and sodium ferric gluconate.

INFeD is unlikely to generate material growth through new indications or exclusivity extension. Its financial trajectory is best characterized as a mature, low-growth or declining branded-generic asset with possible episodic volume increases during shortages of alternative intravenous iron products.

What is INFeD and how is it used?

INFeD is iron dextran injection, USP, supplied at 50 mg elemental iron per mL. It is administered intravenously or intramuscularly for iron-deficiency anemia in patients who cannot tolerate or adequately respond to oral iron. The FDA-approved label includes patients with documented iron deficiency in whom oral iron is ineffective or impractical. [1]

The product has a high elemental-iron concentration and can support large replacement doses. That dosing advantage is offset by a boxed warning for serious hypersensitivity reactions, including anaphylaxis. The label requires a test dose and observation before the remainder of the dose is administered. [1]

Attribute	INFeD
Active ingredient	Iron dextran
Dosage form	Injectable solution
Strength	50 mg elemental iron/mL
FDA application	NDA 017441
Route	Intravenous or intramuscular
Primary use	Iron-deficiency anemia
Regulatory status	Approved NDA product
Exclusivity position	No meaningful current market exclusivity
Patent position	No material active composition-of-matter protection identified
Key commercial issue	Safety perception and competition from newer IV irons

What is the FDA and Orange Book status of INFeD?

INFeD is an FDA-approved NDA product rather than a conventional abbreviated new drug application. Drugs@FDA identifies INFeD under NDA 017441. The product has been marketed for decades, placing it outside the normal period of new-drug regulatory exclusivity. [2]

The Orange Book is relevant to INFeD because it records FDA-approved products and any applicable patent or exclusivity information. For a product of this age, the commercial question is not whether the original approval remains valid. It does. The question is whether any listed patent or regulatory barrier prevents competing iron-dextran products or alternative IV iron products from entering the market. No current barrier of that type is central to INFeD's market position. [3]

Does INFeD have FDA exclusivity?

No material FDA exclusivity remains. Any five-year new chemical entity exclusivity, three-year clinical-investigation exclusivity, or pediatric exclusivity associated with the original approval has expired.

INFeD's remaining commercial protection comes from the product's established brand, manufacturing know-how, customer relationships, and regulatory maintenance rather than from exclusivity.

When does INFeD lose patent protection?

INFeD's original patent period expired decades ago. The product was approved in the 1970s, and any original composition-of-matter or formulation protection has long since lapsed.

There is no known patent-expiration event comparable to the upcoming loss of exclusivity for a recently launched branded drug. A current competitor would primarily evaluate:

• FDA approval requirements;
• manufacturing validation;
• sterile injectable production capacity;
• drug-master-file or active-ingredient sourcing;
• pharmacovigilance obligations;
• hospital contracting;
• reimbursement and substitution rules.

The absence of meaningful patent protection does not eliminate entry barriers. Sterile injectables have higher manufacturing and quality-control requirements than oral generic drugs. Those barriers can support pricing even when patent rights have expired.

How many patents cover INFeD?

The commercially relevant patent count is effectively zero for current market protection. Historical patents associated with iron dextran and its formulation are expired or no longer capable of blocking ordinary market entry.

The relevant IP may still include manufacturing processes, specifications, analytical methods, container systems, trademarks, and confidential know-how. Those rights do not create a conventional patent moat around the product.

Are formulation patents protecting INFeD?

No material formulation-patent protection is central to INFeD's present commercial position. The product's formulation is longstanding and technically established.

Potential manufacturing know-how may concern:

• dextran molecular-weight distribution;
• iron-carbohydrate complex formation;
• impurity controls;
• sterilization;
• particulate limits;
• container closure integrity;
• release testing.

These elements can make development and approval more difficult, but they do not operate like an unexpired patent covering the finished product.

Are method-of-use patents protecting INFeD?

No material method-of-use patent estate is associated with the core use of INFeD for iron-deficiency anemia. Any historical method claims would be expected to have expired.

Commercial differentiation therefore depends on clinical positioning, physician familiarity, label language, dose convenience, safety management, and price rather than on patented indications.

Are generic or Paragraph IV challenges affecting INFeD?

Paragraph IV litigation is not a major current risk driver for INFeD. Because its core patent estate is expired or immaterial, a potential competitor would not need to organize its strategy around challenging a blocking patent in the same way it would for a protected small-molecule brand.

The more relevant entry pathways are:

1. An ANDA for an iron-dextran injection that demonstrates pharmaceutical equivalence and bioequivalence or another applicable approval standard.
2. A competing NDA for a distinct iron-carbohydrate complex.
3. Contract manufacturing or acquisition of an approved injectable product.
4. Hospital purchasing substitution involving alternative IV iron products.

The absence of prominent recent Paragraph IV litigation indicates that litigation is not the main constraint on competition. Manufacturing economics and market access are more important.

What patent litigation affects INFeD?

No major current patent litigation is central to the INFeD investment case. The product is not positioned like a newly launched specialty drug with active patent enforcement, continuing continuation applications, or a dense Orange Book estate.

Litigation exposure can still arise from:

• product-liability claims involving hypersensitivity;
• manufacturing-quality allegations;
• labeling and pharmacovigilance disputes;
• antitrust or contracting claims;
• trademark disputes;
• supply agreements.

These risks are distinct from patent litigation and are more relevant to a mature injectable product.

What companies compete with INFeD?

INFeD competes with both iron-dextran products and newer IV iron agents. The principal competitors are:

Product	Active ingredient	Commercial positioning
INFeD	Iron dextran	Established, high-dose IV or IM iron; lower-cost mature product
Venofer	Iron sucrose	Widely used in dialysis and chronic kidney disease
Ferrlecit	Sodium ferric gluconate	Established dialysis and renal-care product
Injectafer	Ferric carboxymaltose	Large-dose administration and broad outpatient use
Feraheme	Ferumoxytol	Two-dose IV regimen; chronic kidney disease and iron-deficiency anemia
Monoferric	Ferric derisomaltose	Large-dose replacement with outpatient convenience

FDA-approved labels for these products reflect differences in dosing, patient populations, administration time, and hypersensitivity warnings. [4-8]

How does INFeD compare with newer IV iron products?

INFeD's principal advantage is cost and the ability to deliver substantial iron replacement in a mature product format. Its disadvantages include the test-dose requirement, administration complexity, and stronger physician concern regarding severe hypersensitivity reactions.

Newer products typically compete through:

• larger labeled doses;
• fewer administrations;
• outpatient infusion convenience;
• updated clinical positioning;
• commercial contracting;
• perceived safety advantages;
• stronger manufacturer support.

The market has therefore shifted from a simple iron-replacement decision toward a total-cost-of-care decision. Providers consider chair time, nursing labor, adverse-event monitoring, repeat visits, acquisition cost, and payer policy.

What is the commercial market for INFeD?

INFeD participates in the broader intravenous iron market, which is supported by several durable demand drivers:

• chronic kidney disease;
• inflammatory bowel disease;
• heart failure;
• oncology-related anemia;
• malabsorption;
• intolerance or nonresponse to oral iron;
• blood-loss conditions;
• perioperative anemia management;
• postpartum iron deficiency.

The product's addressable market is narrower than the total IV iron market because many institutions prefer products with simpler dosing and a more favorable hypersensitivity profile.

INFeD is most commercially relevant where procurement teams prioritize acquisition cost or where clinicians are comfortable with its established dosing protocol. It is less competitive in settings where infusion-center efficiency and rapid large-dose administration have high economic value.

What is the financial trajectory of INFeD?

No publicly disclosed financial filing isolates INFeD revenue, unit volume, gross margin, or operating profit. Its commercial owner has historically reported results at broader business-segment levels rather than at the individual-product level. AbbVie's public filings, for example, do not provide a separate INFeD revenue line. [9]

The likely financial trajectory is:

Period	Expected commercial pattern
Historical launch and early commercialization	Protected or semi-protected product economics
Post-exclusivity period	Price and share pressure from competing iron products
Mature branded period	Stable but limited demand, dependent on institutional contracts
Current market	Low-growth asset with episodic shortage-related upside
Longer term	Gradual erosion unless supported by supply disruption, acquisition, or channel expansion

Revenue sensitivity is driven by volume and net price rather than by new patent-protected indications. Key variables include:

• hospital contract wins and losses;
• wholesale acquisition cost;
• rebates and chargebacks;
• pharmacy-benefit coverage;
• product shortages;
• raw-material availability;
• sterile manufacturing capacity;
• adverse-event concerns;
• substitution by iron sucrose or ferric carboxymaltose;
• shifts from inpatient to outpatient infusion.

A temporary supply disruption affecting a major competitor can increase INFeD demand. That benefit may reverse when normal supply resumes.

How strong is the INFeD patent estate?

The patent estate is weak as a current commercial defense.

Patent-estate factor	Assessment
Composition-of-matter protection	Expired
Core formulation protection	No material active barrier identified
Method-of-use protection	No material active barrier identified
Orange Book leverage	Limited
Regulatory exclusivity	Expired
Manufacturing know-how	Potentially relevant
Trademark value	Relevant for brand recognition
Litigation leverage	Low for patent disputes

INFeD's defensibility is operational rather than legal. A competitor must still build or source compliant sterile manufacturing capacity, obtain FDA approval, satisfy quality requirements, and win institutional business. Those factors can delay entry, but they do not support premium pricing comparable to a patented specialty drug.

What manufacturing and supply barriers affect INFeD?

Manufacturing is a more important barrier than patents. Iron-dextran injection requires controlled production of a complex iron-carbohydrate formulation with consistent composition and low levels of impurities and particulates.

Supply risks include:

• dependence on specialized active-ingredient suppliers;
• limited sterile-fill capacity;
• batch failures;
• facility inspections;
• container-closure defects;
• raw-material disruptions;
• product recalls;
• changes in manufacturing site;
• regulatory remediation.

The product's long history can reduce development risk, but it does not eliminate the need for current process validation and FDA-compliant quality systems.

FDA drug-shortage records and manufacturer communications should be monitored because shortage conditions can materially change INFeD's short-term volume without changing its long-term market position. [10]

Is there biosimilar risk for INFeD?

Biosimilar risk is not applicable in the conventional regulatory sense. INFeD is a chemically defined iron-carbohydrate injectable, not a biologic approved under the Public Health Service Act.

Its competitive risks arise from:

• generic or follow-on iron-dextran products;
• alternative non-biologic IV irons;
• hospital formulary substitution;
• payer-directed utilization management;
• lower-cost iron sucrose;
• high-dose products with fewer administrations.

The absence of biosimilar exposure does not protect INFeD from substitution. In practice, alternative IV iron products can capture demand without being biosimilars.

Are licensing deals affecting INFeD?

No major recent licensing transaction is publicly associated with a new INFeD indication, formulation, or patent platform. The product's value is more likely to arise in an acquisition of a mature hospital or specialty portfolio than in a standalone licensing transaction.

Potential transaction value would be based on:

• recurring institutional demand;
• manufacturing rights;
• supply continuity;
• product profitability;
• regulatory history;
• inventory position;
• channel access;
• portfolio synergies with other injectable products.

Because product-level revenue is not separately disclosed, external buyers would need to value INFeD through due diligence rather than relying on public segment reporting.

What generic launch scenarios exist for INFeD?

Three scenarios are commercially plausible:

Continued mature-brand scenario

The existing product retains a stable niche among cost-sensitive hospitals and clinicians familiar with iron dextran. Revenue remains modest and depends on supply reliability.

Follow-on iron-dextran entry

A competitor obtains approval for a comparable iron-dextran injection. Price competition increases, and the branded product loses hospital contracts. The effect would depend on the competitor's sterile manufacturing scale and commercial reach.

Alternative-IV-iron substitution

Hospitals increasingly replace INFeD with iron sucrose, ferric carboxymaltose, ferumoxytol, or ferric derisomaltose. The driver is not patent expiry but the perceived value of fewer administrations, easier dosing, and lower monitoring burden.

The third scenario is the most structurally important because it can erode demand even without a direct iron-dextran generic launch.

What geographic coverage does INFeD have?

INFeD's strongest commercial relevance is in the U.S. market, where the product has FDA approval and established institutional use. International markets may contain separate iron-dextran or iron-carbohydrate products with different trade names, sponsors, formulations, and regulatory histories.

U.S. economics are shaped by:

• FDA approval status;
• Orange Book treatment;
• hospital purchasing groups;
• Medicare and commercial reimbursement;
• 340B pricing;
• outpatient infusion economics;
• wholesaler distribution.

International revenue cannot be inferred from U.S. approval or U.S. labeling. A geographic expansion strategy would require country-specific registrations, pharmacovigilance systems, manufacturing documentation, and reimbursement access.

What is the investment outlook for INFeD?

INFeD is a cash-flow and supply-chain asset rather than an innovation asset. Its upside is limited by the absence of exclusivity and by competition from newer IV iron products. Its downside is concentrated in substitution, quality events, supply interruptions, and liability associated with severe hypersensitivity reactions.

The product may retain value in a portfolio of mature injectables if it has:

• reliable supply;
• favorable manufacturing cost;
• stable institutional accounts;
• limited quality remediation;
• strong wholesaler access;
• pricing discipline.

It is less attractive as a standalone growth investment because there is no visible patent catalyst, new indication catalyst, or biologic lifecycle opportunity.

Key Takeaways

• INFeD is iron dextran injection, an established FDA-approved IV and IM iron product under NDA 017441.
• Its original patent and regulatory-exclusivity periods expired decades ago.
• No material current patent estate is driving market protection.
• Paragraph IV litigation and biosimilar competition are not central risks.
• The main competitive threats are iron sucrose, ferric carboxymaltose, ferumoxytol, ferric derisomaltose, and sodium ferric gluconate.
• Product-level INFeD revenue is not publicly disclosed.
• The financial profile is mature, low-growth, and sensitive to hospital contracts, supply reliability, pricing, and substitution.
• Sterile manufacturing, quality compliance, and supply continuity are more important barriers than patents.
• Shortages of competing IV iron products can create temporary volume upside.
• Long-term demand is exposed to newer products offering simpler dosing and fewer administrations.

FAQs

Does INFeD have a patent-protected market?

No material current patent protection is central to INFeD's market position. Its original patent protection expired long ago.

Is INFeD interchangeable with iron sucrose?

No. Iron dextran and iron sucrose are different iron-carbohydrate complexes with separate labels, dosing protocols, and clinical considerations. Substitution requires clinical and institutional approval.

Can INFeD be administered as a total-dose infusion?

The prescribing information governs administration. INFeD labeling includes a test dose and monitoring requirements because of serious hypersensitivity risk. [1]

Is INFeD included in Medicare reimbursement?

Medicare coverage and payment depend on the site of care, patient diagnosis, billing code, acquisition price, and applicable payment system. Coverage does not establish product-level profitability.

What is the main reason hospitals may stop using INFeD?

Hospitals may shift to competing IV iron products because of hypersensitivity concerns, administration requirements, infusion-center efficiency, physician preference, payer policy, or a preference for newer large-dose products.

References

1. DailyMed. (n.d.). INFeD iron dextran injection prescribing information. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/

2. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: INFeD, NDA 017441. https://www.accessdata.fda.gov/scripts/cder/daf/

3. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book

4. U.S. Food and Drug Administration. (n.d.). Venofer prescribing information. https://www.accessdata.fda.gov/scripts/cder/daf/

5. U.S. Food and Drug Administration. (n.d.). Injectafer prescribing information. https://www.accessdata.fda.gov/scripts/cder/daf/

6. U.S. Food and Drug Administration. (n.d.). Feraheme prescribing information. https://www.accessdata.fda.gov/scripts/cder/daf/

7. U.S. Food and Drug Administration. (n.d.). Monoferric prescribing information. https://www.accessdata.fda.gov/scripts/cder/daf/

8. U.S. Food and Drug Administration. (n.d.). Ferrlecit prescribing information. https://www.accessdata.fda.gov/scripts/cder/daf/

9. AbbVie Inc. (2024). Annual report for the fiscal year ended December 31, 2023. U.S. Securities and Exchange Commission. https://www.sec.gov/

10. U.S. Food and Drug Administration. (n.d.). Drug shortages. https://www.accessdata.fda.gov/scripts/drugshortages/