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IRON DEXTRAN Drug Patent Profile
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When do Iron Dextran patents expire, and when can generic versions of Iron Dextran launch?
Iron Dextran is a drug marketed by Sanofi Aventis Us and is included in one NDA.
The generic ingredient in IRON DEXTRAN 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.
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Questions you can ask:
- What is the 5 year forecast for IRON DEXTRAN?
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Summary for IRON DEXTRAN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 27 |
| Clinical Trials: | 75 |
| What excipients (inactive ingredients) are in IRON DEXTRAN? | IRON DEXTRAN excipients list |
| DailyMed Link: | IRON DEXTRAN at DailyMed |
Recent Clinical Trials for IRON DEXTRAN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Assiut University | PHASE4 |
| NanoEcho AB | PHASE2 |
| Hamad Medical Corporation | NA |
Anatomical Therapeutic Chemical (ATC) Classes for IRON DEXTRAN
US Patents and Regulatory Information for IRON DEXTRAN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | IRON DEXTRAN | iron dextran | INJECTABLE;INJECTION | 010787-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Iron Dextran Market Dynamics, Patent Position, FDA Status, and Financial Trajectory
Iron dextran is a mature, injectable iron replacement product with limited patent protection, no meaningful biologic exclusivity, and declining strategic importance relative to newer intravenous iron products. Its commercial value is concentrated in low-cost hospital and specialty-pharmacy channels, where high-dose administration and price remain competitive advantages. The principal constraints are anaphylaxis risk, clinical preference for newer formulations, manufacturing complexity, and limited public visibility into product-level revenue.
What is the current market position of iron dextran?
Iron dextran is an intravenous iron complex used to treat iron-deficiency anemia when oral iron is ineffective, poorly tolerated, or clinically inadequate. The product class includes branded and generic versions of iron dextran injection, principally associated with INFeD and Dexferrum.
The market is mature and largely genericized. Iron dextran competes with:
- Iron sucrose, including Venofer and generic products
- Sodium ferric gluconate, including Ferrlecit and generic products
- Ferumoxytol, marketed as Feraheme
- Ferric carboxymaltose, marketed as Injectafer
- Ferric derisomaltose, marketed as Monoferric
Iron dextran can deliver a large replacement dose in fewer administrations than iron sucrose or sodium ferric gluconate. That advantage is offset by the product’s boxed warning for serious hypersensitivity reactions and the need for clinical monitoring during administration.[1]
How does iron dextran compare with competing intravenous irons?
| Product | Typical strategic advantage | Principal limitation | Market position |
|---|---|---|---|
| Iron dextran | Low acquisition cost; large-dose replacement possible | Severe hypersensitivity warning; older product | Mature generic |
| Iron sucrose | Established safety and broad hospital use | Multiple infusions often required | High-volume generic and branded market |
| Sodium ferric gluconate | Long clinical history; dialysis use | Dose and administration limitations | Established dialysis product |
| Ferumoxytol | Two-dose regimen; branded reimbursement strategy | Higher cost; safety monitoring | Branded specialty product |
| Ferric carboxymaltose | High-dose administration; broad outpatient use | High price; hypophosphatemia concern | Major branded franchise |
| Ferric derisomaltose | Large-dose administration; lower infusion burden | Limiteder commercial scale than leading brands | Branded challenger |
Iron dextran’s competitive position is strongest where hospitals prioritize acquisition cost and have protocols for test dosing, observation, and emergency management. Its position is weaker in outpatient settings where physicians prioritize newer safety profiles, simpler administration, or manufacturer-supported reimbursement.
What patents protect iron dextran products?
Iron dextran has little remaining composition-of-matter or formulation patent protection in the United States. The active pharmaceutical ingredient is an established iron-carbohydrate complex, and the principal branded products were approved decades ago.
| Product or product family | Regulatory identifier | Patent outlook |
|---|---|---|
| INFeD iron dextran injection | NDA 017441 | No apparent active Orange Book patent barrier of commercial significance |
| Dexferrum iron dextran injection | NDA 018369 | No apparent active Orange Book patent barrier of commercial significance |
| Generic iron dextran injection | ANDA products | Generally subject to abbreviated approval and ordinary manufacturing requirements |
The relevant commercial protections are therefore regulatory and operational rather than patent-based. These include manufacturing know-how, control of sterile injectable capacity, supplier relationships, hospital contracts, pharmacovigilance records, and the ability to maintain reliable supply.
Are formulation patents still relevant?
Formulation patents are unlikely to provide a meaningful barrier for conventional iron dextran injection. The established product is an injectable iron-carbohydrate complex in a standard parenteral dosage form. Any surviving formulation or process claims would need to be assessed at the individual patent and product level, but they do not appear to create a broad market exclusion comparable to the patent estates supporting newer branded intravenous irons.
Manufacturing know-how can still matter. Iron-carbohydrate complexes require control of molecular-weight distribution, iron release, sterility, stability, particulate content, and batch consistency. These factors can create practical barriers even when patent rights have expired.
When does iron dextran lose exclusivity?
Iron dextran lost the principal economic benefits of exclusivity decades ago. The products are not positioned like recently approved small molecules with active five-year new chemical entity exclusivity, three-year clinical-investigation exclusivity, or a current patent cliff.
FDA approval dates illustrate the age of the products:
| Product | FDA approval pathway | Approximate approval era | Current exclusivity profile |
|---|---|---|---|
| INFeD | NDA | 1970s | No active NCE exclusivity |
| Dexferrum | NDA | 1970s | No active NCE exclusivity |
| Generic iron dextran | ANDA | Later generic approvals | No independent market exclusivity of strategic significance |
The commercial question is therefore not when iron dextran loses exclusivity. It is whether individual manufacturers can retain profitable supply through cost control, contracting, and reliable availability.
What is the FDA regulatory status of iron dextran?
FDA-approved iron dextran injection remains a prescription intravenous product. The FDA labeling carries a boxed warning for fatal and life-threatening hypersensitivity reactions. The label requires access to personnel and therapies capable of treating anaphylaxis, with observation during and after administration.[1]
What safety issues affect demand?
The key safety factors are:
- Anaphylaxis and severe hypersensitivity reactions
- Infusion-related reactions
- Product-specific concerns regarding test dosing and administration protocols
- Need for monitoring in settings equipped for emergency treatment
- Clinical preference for newer products with different safety and dosing profiles
The boxed warning does not eliminate use. It does, however, influence formulary placement, physician selection, infusion-center protocols, and hospital liability assessments.
Iron dextran is also associated with a higher perceived safety burden than several newer alternatives. This perception can reduce utilization even when the acquisition price is substantially lower.
What is the Orange Book status of iron dextran?
The Orange Book is relevant for the listed NDA products and their associated patent certifications. Iron dextran does not appear to have a current patent structure comparable to branded products such as Feraheme, Injectafer, or Monoferric.
A generic applicant seeking approval would typically rely on an ANDA and certify against listed patents, if any remain. Because the core product is old and the active ingredient is established, Paragraph IV litigation risk is generally lower than for modern branded intravenous iron products.
Are there Paragraph IV challenges against iron dextran?
Paragraph IV activity is not a major current market driver for conventional iron dextran. The product’s competitive dynamics are based primarily on generic entry, supply availability, hospital contracting, and clinical substitution rather than patent litigation.
A Paragraph IV challenge would have limited strategic value unless it targeted a specific later-listed formulation or process patent. The core iron dextran market is already exposed to generic competition.
What patent litigation affects iron dextran?
No major current patent litigation appears to define the conventional U.S. iron dextran market. Litigation risk is more relevant to competing intravenous iron products.
| Competing product | Principal patent-risk issue |
|---|---|
| Feraheme | Patents and litigation concerning ferumoxytol composition, formulation, and use |
| Injectafer | Patent protection around ferric carboxymaltose and branded indications |
| Monoferric | Patent and regulatory protection around ferric derisomaltose |
| Iron sucrose | Mature product with extensive generic competition |
| Iron dextran | Limited current patent-driven exclusion |
Settlement agreements are therefore unlikely to determine iron dextran market entry. Any relevant agreements would more likely concern supply, distribution, or manufacturing than delayed generic launches under a patent settlement.
Which companies manufacture or market iron dextran?
The commercial supply base has included branded-product sponsors, generic injectable manufacturers, and specialty hospital suppliers. American Regent has been associated with iron dextran products, including Dexferrum, while INFeD has historically been marketed through different commercial entities over its product life.
The relevant competitive set can change because injectable products are frequently transferred, discontinued, relabeled, or supplied through contract-manufacturing arrangements. FDA’s Drugs@FDA database and current product labeling are the controlling sources for present sponsor and manufacturer status.[2]
What creates manufacturing and IP barriers?
The principal barriers are practical:
- Sterile injectable manufacturing capacity
- Validated iron-dextran complex production
- Control of impurities and particulate matter
- Reliable vial and container-closure systems
- FDA-compliant quality systems
- Supply continuity for hospitals
- Ability to meet injectable-drug inspection and shortage requirements
These barriers can support pricing above commodity levels, but they do not create the margin profile of a protected branded medicine.
What is the financial trajectory for iron dextran?
Product-level revenue for iron dextran is generally not disclosed because the product is sold by private companies, diversified generic manufacturers, or business units that do not report brand-level sales. Public companies typically report broader segments such as injectables, hospital products, or specialty pharmaceuticals.
The financial trajectory is best characterized as mature, low-growth, and price-sensitive.
| Financial driver | Directional effect |
|---|---|
| Generic competition | Reduces price and gross margin |
| Large-dose administration | Supports clinical utility and lower administration burden |
| Boxed warning | Limits use in some outpatient and office settings |
| Hospital tenders | Compresses net price |
| Injectable shortages | Can temporarily improve pricing and volume |
| Newer IV iron products | Erodes share in premium outpatient channels |
| Manufacturing concentration | Can create temporary supply leverage |
| Stable anemia prevalence | Supports baseline demand |
Iron dextran can remain profitable where the manufacturer has low production costs and a stable hospital customer base. The product is unlikely to generate material top-line expansion without a supply disruption, new distribution arrangement, or a meaningful shift toward cost-sensitive use.
How does reimbursement affect revenue?
Reimbursement depends on site of care, payer policy, dosage, administration fees, and the applicable coding and payment methodology. In hospital outpatient departments, acquisition cost and reimbursement spread are important. In physician offices and infusion centers, product cost, buy-and-bill economics, and monitoring requirements influence product selection.
Newer branded irons may support higher reimbursement or manufacturer contracting, while iron dextran competes mainly on low acquisition cost. A low product price can still produce attractive provider economics if the administration payment is separate, but the manufacturer captures only the drug component.
What generic launch risks exist for iron dextran?
The principal generic-entry risk is already realized. Conventional iron dextran is exposed to existing generic supply and does not depend on a future patent expiration date.
Future market disruption could come from:
- New ANDA approvals
- Reentry by a manufacturer after a shortage
- Contract-manufacturing expansion
- Hospital purchasing-group renegotiation
- Product discontinuation by an incumbent supplier
- Substitution toward iron sucrose or ferric derisomaltose
The most material risk for an incumbent is not a single generic launch. It is cumulative price erosion combined with volume migration to alternative iron complexes.
Is biosimilar competition relevant to iron dextran?
No. Iron dextran is a chemically defined small-molecule iron-carbohydrate product, not a biologic regulated through the biosimilar pathway under the Public Health Service Act. Competitors enter through generic-drug or related abbreviated regulatory pathways rather than biosimilar applications.
The absence of biosimilar risk does not protect the product. Generic and therapeutic substitution already create the relevant competitive pressure.
What licensing deals affect iron dextran?
There is no widely disclosed, current licensing transaction that controls the iron dextran market in the way licensing arrangements can affect newer branded medicines. Commercial rights have historically moved through product acquisitions, portfolio transfers, distribution arrangements, and manufacturer changes.
The value of any transaction involving iron dextran would depend on:
- Current FDA approval status
- Manufacturing ownership
- Product-transfer obligations
- Existing hospital contracts
- Supply history
- Pharmacovigilance liabilities
- Marketed versus unmarketed status
- Capacity to produce sterile injectable batches
A transaction would be more likely to be an asset or product-line deal than a high-value license based on enforceable patent rights.
What geographic markets matter most?
The United States is commercially important because of its large hospital and specialty-infusion market, established FDA pathway, and reimbursement infrastructure. Europe and other developed markets have their own iron-carbohydrate products, procurement systems, and regulatory classifications. Product approval and naming conventions differ by jurisdiction.
Geographic value depends on local demand for intravenous iron, hospital tender structures, prevalence of chronic kidney disease and anemia, regulatory requirements, and availability of competing products. A U.S. approval does not establish automatic market access elsewhere.
How strong is the iron dextran patent estate?
The patent estate is weak from a commercial-exclusion perspective.
| Estate dimension | Assessment |
|---|---|
| Composition-of-matter protection | Expired or commercially exhausted |
| Core formulation protection | Limited strategic value |
| Method-of-use protection | Unlikely to block ordinary generic use |
| Orange Book leverage | Low |
| Paragraph IV exposure | Low as a current strategic issue |
| Manufacturing know-how | Moderate practical importance |
| Regulatory and quality barriers | More important than patent rights |
| Litigation leverage | Limited |
Iron dextran’s defensibility rests on supply reliability, cost, regulatory execution, and customer relationships. It does not rest on a broad active patent moat.
Key Takeaways
- Iron dextran is a mature generic intravenous iron product with no meaningful current composition-of-matter exclusivity.
- INFeD and Dexferrum are the principal historical branded references, while generic iron dextran supplies the core market.
- The product retains a cost and large-dose administration advantage.
- Its boxed warning for serious hypersensitivity reactions limits use relative to newer intravenous irons.
- There is no material biosimilar pathway risk because iron dextran is not a biologic.
- Paragraph IV challenges, patent settlements, and current patent litigation are not major market drivers.
- Product-level revenue is generally not publicly reported.
- Financial performance is likely stable to declining, with temporary upside during shortages or supplier exits.
- Manufacturing quality, sterile capacity, hospital contracts, and supply continuity are more important than patent rights.
- Competitive pressure comes from iron sucrose, ferumoxytol, ferric carboxymaltose, and ferric derisomaltose.
FAQs About Iron Dextran Market and Exclusivity
Is iron dextran still commercially viable?
Yes. It remains viable in cost-sensitive hospital settings and where clinicians are comfortable managing hypersensitivity risk. Its commercial ceiling is limited by generic pricing and substitution to newer intravenous irons.
Does INFeD have active patent protection?
No broad, commercially meaningful patent barrier is generally associated with the conventional INFeD product. Current status should be confirmed against the FDA Orange Book and the applicable product record.
Is Dexferrum a biologic?
No. Dexferrum is an iron-carbohydrate injectable product and does not compete through the biosimilar approval pathway.
Which intravenous iron has the strongest commercial position against iron dextran?
Ferric carboxymaltose has a strong premium outpatient position, while iron sucrose has broad generic utilization. Ferumoxytol and ferric derisomaltose compete through high-dose or reduced-infusion regimens.
Can a generic manufacturer launch iron dextran without Paragraph IV litigation?
Potentially, yes, if no relevant unexpired Orange Book patent blocks approval. Conventional iron dextran is an old product, so approval risk is more likely to involve FDA quality, bioequivalence, manufacturing, and supply requirements than patent litigation.
References
- U.S. Food and Drug Administration. (n.d.). INFeD (iron dextran injection) prescribing information. FDA.
- U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs database. FDA.
- U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. FDA.
- U.S. Food and Drug Administration. (n.d.). Drug shortages database. FDA.
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