FERUMOXYTOL Drug Patent Profile

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

Ferumoxytol is a drug marketed by Sandoz and is included in one NDA.

The generic ingredient in FERUMOXYTOL is ferumoxytol. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the ferumoxytol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ferumoxytol

A generic version of FERUMOXYTOL was approved as ferumoxytol by SANDOZ on January 15^th, 2021.

Summary for FERUMOXYTOL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	90
Drug Prices:	Drug price information for FERUMOXYTOL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FERUMOXYTOL
DailyMed Link:	FERUMOXYTOL at DailyMed

See drug prices for FERUMOXYTOL

Recent Clinical Trials for FERUMOXYTOL

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

Sponsor	Phase
Medical University of Vienna	EARLY_PHASE1
University of Alberta	PHASE2
Canadian Institutes of Health Research (CIHR)	PHASE2

See all FERUMOXYTOL clinical trials

Pharmacology for FERUMOXYTOL

Drug Class

Parenteral Iron Replacement

Paragraph IV (Patent) Challenges for FERUMOXYTOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FERAHEME	Injection	ferumoxytol	30 mg/mL, 17 mL single-use vials	022180	1	2015-12-04

US Patents and Regulatory Information for FERUMOXYTOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	FERUMOXYTOL	ferumoxytol	SOLUTION;INTRAVENOUS	206604-001	Jan 15, 2021	AB	RX	No	No

EU/EMA Drug Approvals for FERUMOXYTOL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Takeda Pharma A/S	Rienso	ferumoxytol	EMEA/H/C/002215Rienso is indicated for the intravenous treatment of iron-deficiency anaemia in adult patients with chronic kidney disease (CKD).The diagnosis of iron deficiency must be based on appropriate laboratory tests (see section 4.2).	Withdrawn	no	no	no	2012-06-15

Ferumoxytol Market Dynamics, Revenue Trajectory, Patent Exclusivity, and Generic Risk

Last updated: August 12, 2026

Ferumoxytol, marketed as Feraheme, is a U.S. intravenous iron product used primarily to treat iron-deficiency anemia in adults with chronic kidney disease and in patients who cannot tolerate or have failed oral iron. Its commercial profile combines durable clinical demand with increasing generic and formulation competition. The product’s strongest market advantages are rapid two-dose administration, established nephrology use, and a differentiated colloidal iron formulation. Its principal risks are generic pricing pressure, payer preference for lower-cost intravenous iron, and limited transparency after AMAG Pharmaceuticals was acquired by Covis Pharma.

What is ferumoxytol and how is Feraheme used?

Ferumoxytol is an intravenous iron-carbohydrate nanoparticle. Feraheme is supplied as a 510 mg elemental iron dose in a 17 mL vial and is administered as two doses separated by three to eight days. The FDA approved Feraheme in 2009 for iron-deficiency anemia in adults with chronic kidney disease. In 2018, the FDA expanded the indication to adults with iron-deficiency anemia who have intolerance or an unsatisfactory response to oral iron, or who have chronic kidney disease.[1]

The product carries a boxed warning for serious hypersensitivity reactions, including anaphylaxis. Administration requires monitoring during and for at least 30 minutes after infusion, with emergency treatment available.[1]

Ferumoxytol clinical and commercial positioning

Feraheme competes with several intravenous iron products:

Product	Active ingredient	Typical administration profile	Principal commercial position
Feraheme	Ferumoxytol	Two 510 mg doses	Rapid repletion with two visits
Injectafer	Ferric carboxymaltose	One or two doses, depending on regimen	High-dose outpatient iron
Venofer	Iron sucrose	Multiple smaller doses	Established dialysis and CKD product
Monoferric	Ferric derisomaltose	Often one high-dose infusion	Reduced administration burden
Infed	Iron dextran	Variable	Older product with broad dosing flexibility
Ferrlecit	Sodium ferric gluconate	Repeated smaller doses	Dialysis-focused use

Feraheme’s competitive value is highest when physicians want to avoid repeated low-dose infusions. Its disadvantages include hypersensitivity monitoring, infusion-center capacity requirements, and price competition from generic iron sucrose and newer branded high-dose products.

How large is the ferumoxytol market?

Feraheme generated approximately $233 million in net sales in 2019, according to AMAG Pharmaceuticals’ public filings.[2] Sales declined from earlier peak levels after safety-label changes, reimbursement pressure, and competition from Injectafer, Venofer, and other intravenous iron products.

AMAG’s Feraheme revenue history was approximately:

Year	Feraheme net sales	Market context
2016	About $250 million	Mature branded product
2017	About $251 million	Stable demand before broader indication benefit
2018	About $234 million	FDA label expansion
2019	About $233 million	Persistent competition and pricing pressure
2020 onward	Not separately reported on a comparable public basis	AMAG acquired by Covis; private-company disclosure

The 2018 indication expansion increased the addressable population beyond chronic kidney disease. The commercial effect was moderated by the need to compete against high-dose ferric carboxymaltose and ferric derisomaltose products in hematology, gastroenterology, women’s health, and general outpatient medicine.

What is the current financial trajectory of Feraheme?

Current standalone Feraheme revenue is not disclosed in public filings comparable to AMAG’s pre-acquisition reporting. Covis Pharma acquired AMAG in 2020 and subsequently operated as a private company.[3] The absence of product-level reporting prevents a reliable current-year revenue estimate from public company disclosures.

The financial trajectory is best characterized as:

1. Mature branded revenue before acquisition.
2. Moderate erosion from competing intravenous irons.
3. Continued clinical demand from CKD and oral-iron-intolerant patients.
4. Higher generic risk as ferumoxytol injection approvals expand.
5. Reduced financial visibility after the product moved into private ownership.

Feraheme remains commercially relevant because intravenous iron is a recurring treatment category. Patients with CKD, inflammatory disease, gastrointestinal blood loss, heavy menstrual bleeding, and malabsorption can require repeated iron treatment. Demand is less dependent on a single acute episode than many hospital medicines.

When does ferumoxytol lose exclusivity?

Feraheme’s key U.S. regulatory exclusivity periods have expired. The original new-drug exclusivity period ended years ago, and the product is now exposed primarily to patent-based protection and ordinary market barriers.

The 2018 supplemental indication did not create a new five-year new chemical entity exclusivity period. FDA approval of the supplemental indication expanded labeling but did not reset the product’s core exclusivity term.[1]

What patents protect Feraheme?

Feraheme’s patent protection has historically included patents directed to iron-carbohydrate complexes, compositions, pharmaceutical formulations, and methods of treating iron-deficiency conditions. The principal patent family associated with ferumoxytol includes U.S. Patent No. 7,871,598 and related continuation or divisional filings.[4]

Patent analysis should distinguish between:

• Composition patents covering the iron-carbohydrate complex.
• Formulation patents covering injectable compositions.
• Manufacturing patents covering preparation or purification.
• Method-of-use patents covering treatment of iron deficiency or specific patient populations.
• FDA Orange Book listings, which determine which patents must be addressed by an abbreviated new drug application.

The practical protection period is narrower than the full patent portfolio. A patent that does not appear in the Orange Book may still create litigation or manufacturing risk, but it does not automatically block an ANDA applicant through the standard Paragraph IV process.

What is the Orange Book status of ferumoxytol?

The FDA Orange Book identifies patents and regulatory exclusivities associated with approved drug products. Ferumoxytol applicants must evaluate the current Feraheme listing, including patent status codes, expiration dates, pediatric exclusivity, and any delisting activity.[5]

The relevant legal distinction is:

• An Orange Book-listed patent can trigger a Paragraph IV certification and patent litigation.
• A non-listed process or manufacturing patent can still support a separate infringement claim.
• A patent expiration date does not guarantee immediate generic launch if other listed patents, injunctions, regulatory deficiencies, or commercial agreements remain.

Ferumoxytol is an injectable complex product rather than a conventional small-molecule tablet. The technical complexity of demonstrating pharmaceutical equivalence and product quality can delay generic commercialization even after key patents expire.

Which companies are challenging Feraheme with generics?

Generic competition has emerged through ANDA filings and FDA approvals for ferumoxytol injection. Companies active or associated with the broader generic intravenous iron market include Sandoz, Teva, Lupin, Dr. Reddy’s Laboratories, and other injectable-drug manufacturers. The exact competitive set changes as ANDAs are approved, withdrawn, transferred, or delayed.

What Paragraph IV challenges affect ferumoxytol?

A Paragraph IV certification asserts that an Orange Book-listed patent is invalid, unenforceable, or will not be infringed by the proposed generic. The filing can trigger a 45-day patent-infringement action by the brand owner and a potential 30-month FDA approval stay under the Hatch-Waxman Act.[6]

For Feraheme, the main Paragraph IV risks are:

• Composition or complex-structure patents.
• Injectable formulation patents.
• Treatment-method claims.
• Continuation patents filed late in the product life cycle.
• Patent litigation involving the precise ferumoxytol particle and carbohydrate structure.

Publicly available information does not establish a single, ongoing litigation event that blocks all ferumoxytol generic approvals. Generic entry risk should therefore be assessed by applicant, patent certification, FDA approval status, and settlement terms rather than by the existence of the brand’s historical patent portfolio alone.

How strong is the ferumoxytol patent estate?

The patent estate is moderately strong technically but weaker commercially than it was during the product’s launch period.

Technical strength

Ferumoxytol is a complex injectable iron-carbohydrate product. Generic manufacturers must establish equivalence in areas that are more demanding than ordinary tablet bioequivalence, including:

• Particle size and size distribution.
• Iron-carbohydrate structure.
• Iron release characteristics.
• Physicochemical properties.
• Impurity profile.
• Stability and container compatibility.
• Immunogenicity and hypersensitivity risk.

These requirements can create manufacturing barriers even when patent protection has narrowed.

Legal strength

The legal strength of the estate depends on claim scope, expiration dates, prosecution history, prior art, and whether the claims cover the commercial product without requiring difficult infringement proof. Composition claims generally provide stronger exclusion than narrow method-of-use claims. Method claims may have limited practical value when physicians can prescribe an approved product for a non-patented indication.

Commercial strength

Commercial protection is weaker because intravenous iron purchasers often include hospitals, dialysis providers, group purchasing organizations, and managed-care plans that negotiate heavily on price. A generic with acceptable supply reliability can gain share rapidly through formulary substitution and contract pricing.

What formulation patents protect ferumoxytol?

Feraheme’s formulation protection is directed to an injectable ferumoxytol preparation that maintains the required iron-carbohydrate complex, concentration, stability, and tolerability. Formulation patents can be commercially important because they may prevent direct substitution even after a broad composition patent expires.

The product’s formulation-related barriers include:

• Reproducible synthesis of the iron oxide core.
• Control of the carbohydrate shell.
• Sterile injectable manufacturing.
• Consistent dosing of elemental iron.
• Control of free iron and degradation products.
• Demonstration of comparable pharmacologic and safety characteristics.

A generic manufacturer that uses a different manufacturing process may avoid some process claims while still needing to show that its final product is equivalent under FDA requirements.

What manufacturing and intellectual-property barriers affect generic entry?

Ferumoxytol is more difficult to manufacture than a simple iron salt. The product is a nanoparticulate complex, and small changes in particle or carbohydrate attributes can affect pharmacokinetics, tissue distribution, iron release, and hypersensitivity risk.

Manufacturing barriers include:

1. Specialized sterile facilities.
2. Validated control of nanoparticle attributes.
3. Reliable supply of iron and carbohydrate raw materials.
4. Batch-to-batch consistency.
5. Complex analytical characterization.
6. Regulatory scrutiny of injectable product quality.

These barriers favor established injectable manufacturers. They also create a risk that fewer generic suppliers will enter than initially file ANDAs.

What is the FDA regulatory status of Feraheme?

Feraheme remains an FDA-approved prescription intravenous iron product. Its approved uses include:

• Iron-deficiency anemia in adults with chronic kidney disease.
• Iron-deficiency anemia in adults who have intolerance or an unsatisfactory response to oral iron, or who have chronic kidney disease.[1]

The 2015 boxed warning strengthened the product’s administration requirements after postmarketing reports of serious hypersensitivity reactions. The safety warning affects site-of-care economics because facilities must maintain observation and emergency-response capability.

Feraheme is not a biologic. Biosimilar pathway analysis therefore does not apply. Generic competitors use the ANDA pathway, although the complexity of the iron-carbohydrate product makes the regulatory exercise more demanding than a standard small-molecule injection.

What generic launch scenarios exist for ferumoxytol?

Three scenarios are commercially plausible.

Scenario 1: Limited generic entry

One or two approved suppliers enter with conservative discounts. The brand retains meaningful share through physician familiarity, hospital contracts, and supply reliability. Price erosion is moderate.

Scenario 2: Multi-supplier generic entry

Several manufacturers launch. Payers and purchasing organizations impose stronger substitution pressure, and Feraheme revenue declines sharply. The product becomes a lower-price intravenous iron option with residual branded demand.

Scenario 3: Delayed or constrained generic entry

Patent litigation, FDA review delays, manufacturing deficiencies, or supply limitations reduce the number of active generic suppliers. The brand retains pricing power longer than expected, although payer pressure remains.

The most important variable is not the number of approved ANDAs. It is the number of manufacturers capable of sustained commercial supply.

How does ferumoxytol compare with Injectafer, Venofer, and Monoferric?

Factor	Feraheme	Injectafer	Venofer	Monoferric
Administration burden	Two doses	One or two doses	Often multiple doses	Often one dose
Main strength	Established ferumoxytol use and rapid repletion	High-dose outpatient treatment	Long dialysis history	High-dose convenience
Main weakness	Hypersensitivity warning and generic risk	Brand pricing and competition	More visits in some regimens	Shorter commercial history
Generic exposure	Increasing	Increasing competitive pressure	Mature generic competition	Emerging branded competition
Key buyers	Nephrology, infusion centers, hospitals	Infusion and specialty practices	Dialysis and hospitals	Infusion centers and specialty practices

Feraheme’s strongest defense is clinical familiarity combined with a two-dose regimen. Its weakest point is that competing products can offer one-dose treatment or lower acquisition cost.

What licensing deals and ownership changes affect Feraheme?

AMAG Pharmaceuticals commercialized Feraheme before its acquisition by Covis Pharma in 2020. Covis acquired AMAG in a transaction valued at approximately $647 million, including the assumption of debt and other obligations.[3]

The ownership transition changed Feraheme’s financial reporting:

• AMAG disclosed product-level sales before the acquisition.
• Covis became a private owner and did not provide the same level of product-specific revenue disclosure.
• Commercial strategy shifted from a public-company portfolio model to a private specialty-pharmaceutical platform.
• Feraheme remained an important marketed product but became harder to value from public data.

Publicly reported licensing information is less important to current valuation than the ownership change, patent status, generic approvals, and payer positioning.

What patent litigation and settlement risks affect Feraheme?

The main litigation risk is a Hatch-Waxman action following Paragraph IV certification. Potential outcomes include:

• Litigation through the 30-month stay period.
• Settlement with a negotiated generic entry date.
• Authorized generic arrangements.
• License agreements with launch restrictions.
• Patent invalidation or non-infringement judgments.
• Delayed entry caused by manufacturing or regulatory issues after litigation ends.

Settlement terms can materially alter the revenue trajectory. A settlement that permits an early generic launch may reduce Feraheme value even when the brand wins formal patent litigation.

What is the competitive landscape for intravenous iron?

The intravenous iron market is fragmented across nephrology, dialysis, hospitals, gastroenterology, hematology, obstetrics, and outpatient infusion centers. Product choice depends on dose, infusion time, hypersensitivity protocols, reimbursement, supply, and local contracting.

Feraheme’s revenue exposure is concentrated in the U.S. because the product’s commercial history and FDA labeling have been primarily U.S.-driven. Geographic diversification is limited compared with globally marketed iron products. International ferumoxytol opportunities have also been constrained by regulatory requirements and commercial competition from established iron formulations.

Key Takeaways

• Feraheme is a mature intravenous iron product with recurring demand in CKD and broader iron-deficiency anemia.
• AMAG reported approximately $233 million in Feraheme sales in 2019 before its acquisition by Covis.
• Current standalone revenue is not publicly disclosed on a comparable basis.
• FDA exclusivity has expired; remaining protection depends on patents, regulatory barriers, and manufacturing complexity.
• Ferumoxytol is exposed to generic competition through the ANDA pathway.
• The product’s nanoparticle formulation creates meaningful technical barriers but does not eliminate price erosion risk.
• Feraheme competes against Injectafer, Venofer, Monoferric, and other intravenous iron products.
• Generic launch timing will depend on Orange Book patents, Paragraph IV litigation, FDA approvals, and the number of manufacturers able to supply the market.
• Feraheme is a small-molecule drug product, not a biologic, so biosimilar risk does not apply.
• The commercial outlook is mature to declining, with downside concentrated around multi-supplier generic entry and payer-driven substitution.

FAQs

Does ferumoxytol require a biosimilar application?

No. Ferumoxytol is regulated as a drug product, not a biologic. Competitors generally pursue FDA approval through the ANDA pathway rather than the biosimilar pathway.

Can hospitals substitute generic ferumoxytol automatically?

Substitution depends on state pharmacy law, hospital policy, payer contracts, and whether the generic is rated therapeutically equivalent in the FDA Orange Book. Injectable complex products can also face institution-specific review before broad formulary adoption.

Why is ferumoxytol harder to genericize than iron sucrose?

Ferumoxytol is a nanoparticulate iron-carbohydrate complex with multiple quality attributes that must be controlled. Iron sucrose also requires complex characterization, but ferumoxytol’s particle and carbohydrate structure creates additional equivalence and manufacturing challenges.

Does the Feraheme boxed warning limit its market share?

It can. The warning increases monitoring requirements and may influence physician selection, infusion-site economics, and institutional protocols. It does not prevent use in the approved population.

What would most increase Feraheme’s value?

The strongest value drivers would be delayed generic entry, limited generic manufacturing capacity, stable payer reimbursement, continued CKD demand, and a settlement that preserves branded pricing for a meaningful period.

References

1. U.S. Food and Drug Administration. (2022). Feraheme (ferumoxytol injection) prescribing information.
2. AMAG Pharmaceuticals, Inc. (2020). Form 10-K annual report for the fiscal year ended December 31, 2019. U.S. Securities and Exchange Commission.
3. Covis Pharma Holdings, LLC. (2020). Covis Pharma completes acquisition of AMAG Pharmaceuticals. Company transaction announcement.
4. U.S. Patent and Trademark Office. (2008). U.S. Patent No. 7,871,598: Iron carbohydrate complexes.
5. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.
6. U.S. Code. (2023). 21 U.S.C. § 355(j): Abbreviated applications for new drugs.