FERAHEME Drug Patent Profile

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

Feraheme is a drug marketed by Azurity and is included in one NDA.

The generic ingredient in FERAHEME 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 Feraheme

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

Summary for FERAHEME

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	61
Drug Prices:	Drug price information for FERAHEME
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FERAHEME
What excipients (inactive ingredients) are in FERAHEME?	FERAHEME excipients list
DailyMed Link:	FERAHEME at DailyMed

See drug prices for FERAHEME

Recent Clinical Trials for FERAHEME

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

Sponsor	Phase
Canadian Institutes of Health Research (CIHR)	PHASE2
University of Alberta	PHASE2
National Institutes of Health (NIH)	Early Phase 1

See all FERAHEME clinical trials

Pharmacology for FERAHEME

Drug Class

Parenteral Iron Replacement

Paragraph IV (Patent) Challenges for FERAHEME

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 FERAHEME

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	AB	RX	Yes	Yes

Expired US Patents for FERAHEME

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	8,591,864
Azurity	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	8,926,947
Azurity	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	6,599,498
Azurity	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	7,871,597
Azurity	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	8,501,158
Azurity	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	7,553,479

EU/EMA Drug Approvals for FERAHEME

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

International Patents for FERAHEME

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

Country	Patent Number	Title	Estimated Expiration
Austria	446108
Cyprus	1109527
Germany	60043188
Denmark	1169062
European Patent Office	1169062	OXYDES DE FER COLLOIDAUX THERMOSTABLES RECOUVERTS DE CARBOHYDRATES REDUITS ET DES DERIVES DE CARBOHYDRATES (HEAT STABLE COATED COLLOIDAL IRON OXIDES)
European Patent Office	1522318

Supplementary Protection Certificates for FERAHEME

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1169062	C300558	Netherlands		PRODUCT NAME: FERUMOXYTOL IN IEDERE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/12/774/001-002 20120615
1169062	CA 2012 00050	Denmark
1169062	92114	Luxembourg		PRODUCT NAME: FERUMOXYTOL
1169062	C01169062/01	Switzerland		PRODUCT NAME: FERUMOXYTOL; REGISTRATION NO/DATE: SWISSMEDIC 62033 17.08.2012
1169062	1290043-7	Sweden		PRODUCT NAME: FERUMOXYTOL; REG. NO/DATE: EU/1/12/774/001 20120615
1169062	300558	Netherlands		PRODUCT NAME: FERUMOXYTOL IN IEDERE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/12/774/001-002 20120615

FERAHEME (ferumoxytol) Market Dynamics and Financial Trajectory: Launch, Uptake, Competitive Pressure, and Revenue Risk

Last updated: July 2, 2026

FERAHEME (ferumoxytol) has shifted from steady intravenous iron competition into a more constrained market driven by: (i) payer preference for lower-cost competitors, (ii) safety-driven utilization scrutiny for intravenous iron products, and (iii) limited incremental share growth as major rivals consolidate formularies. Financial trajectory in the US is materially tied to Medicare Part D and commercial formulary decisions, hospital buying patterns, and lab-driven diagnosis-to-infusion workflows rather than outpatient pharmacy substitution.

---

How has FERAHEME performed commercially since approval?

FERAHEME’s commercial trajectory is dominated by two revenue drivers: the volume of administrations (doses infused) and average net price (discounting and contract mix). As a hospital-administered intravenous product, revenue tracks institutional purchasing and payer coverage rather than retail channel throughput.

What are the key US market mechanics for intravenous ferumoxytol?

Demand formation

• Indications tied to iron deficiency anemia in chronic kidney disease and iron deficiency when oral iron is ineffective or not tolerated.
• Treatment is administered in infusion centers, dialysis networks, and acute care settings.

Price realization

• Net price is highly sensitive to group purchasing organization (GPO) contracting, wholesaler pricing, and payer prior authorization practices.
• Hospitals benchmark IV iron agents for cost per treated patient episode.

Utilization controls

• Safety communications and labeling-driven monitoring affect uptake and switching between intravenous iron products.
• Clinician and pharmacy committee preferences influence drug selection for new patients and conversion from prior IV iron.

What does the competitive IV iron landscape mean for FERAHEME growth?

FERAHEME competes in a crowded IV iron market with multiple active ingredients and dosing paradigms. Share is constrained when:

• Payers adopt step edits or restrict coverage to preferred IV iron products.
• Hospitals select products based on dose-per-infusion efficiency and unit economics.
• Safety and interchangeability perceptions shift clinician behavior.

---

Which companies compete with FERAHEME and what pricing leverage do they have?

FERAHEME’s competitive field includes other intravenous iron formulations such as iron sucrose, ferric carboxymaltose, ferric derisomaltose, and low molecular weight iron dextrans depending on market region and formulary. Competitive leverage typically comes from:

• Broader payer formularies
• Lower acquisition cost per infusion cycle
• Product bundling in dialysis and infusion networks
• Evidence of safety and practical administration profiles that reduce monitoring burden

How do infusion schedules drive switching risk away from FERAHEME?

Switching risk rises when competitors offer:

• Higher single-dose administration (fewer visits)
• Shorter chair time or workflow advantages
• Simplified dosing conversion for patient cohorts

FERAHEME’s commercial exposure is therefore tied to whether it remains the preferred option for:

• dialysis-associated iron deficiency anemia treatment pathways
• non-dialysis chronic kidney disease cohorts
• hematology/oncology iron replacement use cases (where payer coverage varies)

---

What patent protection and exclusivity status constrains generic and biosimilar risk for FERAHEME?

FERAHEME is a small-molecule iron product, so the threat is generics or “follow-on” products rather than biosimilars. The critical question for business planning is whether any remaining Orange Book-listed exclusivities or unexpired patents prevent generic entry for the US label.

What does the Orange Book framework determine for generic entry?

For each relevant dosage form and claim set, Orange Book listings typically include:

• Composition of matter patents
• Method-of-use patents
• Manufacturing process patents
• Periods of regulatory exclusivity (where applicable)

The practical effect is:

• Generics must either wait out patent expiration or challenge via Paragraph IV.
• Even if composition patents expire, method-of-use or formulation patents can delay or complicate entry.

(Note: this analysis requires Orange Book listing confirmation for specific patent numbers and dates; the competitive and litigation conclusions depend on those listings.)

---

When does FERAHEME lose exclusivity and what is the generic launch risk window?

Generic entry risk depends on three timelines:

1. Patent expiration for composition and method-of-use claims
2. Any regulatory exclusivity windows
3. Potential patent litigation timelines (automatic stays after Paragraph IV)

What determines the timing of US generic introduction?

Business-critical launch timing is shaped by:

• Whether a generic filer files Paragraph IV certifications
• Whether the reference listed drug (RLD) holder sues for infringement within statutory deadlines
• Whether settlements trigger early entry or shared-launch calendars

Without the specific Orange Book patent-by-patent expiration and litigation posture, a precise loss-of-exclusivity window cannot be stated from the information provided.

---

What formulation, method-of-use, and process IP is most likely to block FERAHEME copycats?

For parenteral iron products, common IP claim categories include:

• Specific compositions and stabilizers
• Particle-related characteristics that define equivalence and stability
• Manufacturing controls producing consistent product attributes
• Indication-specific treatment protocols (method-of-use)

Which copycat pathways face the biggest IP friction?

• Full generic substitution: must demonstrate bioequivalence and match therapeutic profile under the same approved indications.
• “Compatible” but carve-out labeling strategies: may be used to avoid method-of-use infringement, but payers may not accept carve-outs for standard-of-care dosing.
• Process-only approaches: can still be blocked if process patents remain enforceable.

---

What Paragraph IV challenges exist for FERAHEME and what settlement outcomes matter?

Paragraph IV challenges drive the main generics schedule risk. Settlement outcomes can include:

• No-entry agreements until a specific date
• Agreed-upon “at-risk” launch timing
• Shared marketing terms or license arrangements

A complete view requires each Paragraph IV filer, patent challenged, court docket dates, and settlement record. No such list is provided in the input, so an evidence-based litigation and settlement timeline cannot be produced.

---

How do safety warnings and label constraints affect FERAHEME uptake and profitability?

For intravenous iron products, utilization responds quickly to:

• safety communications
• infusion reaction management protocols
• institution-level monitoring requirements
• changes in clinician risk-benefit calculus

FERAHEME’s pricing power and volume are sensitive to whether payers and clinicians perceive it as:

• the safer choice for a defined patient subgroup
• an acceptable alternative after failed oral iron
• a preferred agent in CKD or dialysis care pathways

If safety perception shifts, volume tends to migrate first through:

• dialysis networks
• hospital formularies
• hospital pharmacy substitution policies

---

How does FDA regulatory status shape market access for FERAHEME?

FERAHEME is already approved for its labeled indications and route. The regulatory question for financial modeling becomes:

• whether new labeling restrictions or updates affect coverage
• whether new safety guidance impacts treatment initiation rates
• whether supply disruptions or manufacturing changes affect continuity of supply

What FDA actions typically change commercial trajectory in IV iron?

• label strengthening for adverse reaction management
• requirements for monitoring protocols
• changes in contraindication language
• post-marketing study expectations that influence prescribing behavior

---

What is the likely revenue sensitivity of FERAHEME to payer coverage?

Because FERAHEME is administered in institutional settings, revenue sensitivity is shaped by:

• commercial payer reimbursement policies, including prior authorization
• Medicare coverage behavior and site-of-care cost considerations
• dialysis network contracts and bundled care economics
• group purchasing discounts and GPO channel terms

What moves net price for hospital-administered drugs fastest?

• contract negotiations that reprice the drug versus competitors
• payer escalation of IV iron step therapy
• wholesaler pricing changes that alter discount structures
• tender/auction mechanics in hospital purchasing networks

---

How does FERAHEME compare with ferric carboxymaltose and iron sucrose on competitive axes?

Competitive positioning in the IV iron market usually comes down to:

• dosing convenience (single vs multiple infusions)
• administration time and chair utilization
• lab practice patterns for test frequency and repletion intervals
• adverse reaction profiles and required monitoring
• cost per repletion episode

Which competitive axis most affects share?

• In chronic workflows, chair time and number of infusions drive throughput.
• In payer-restricted environments, acquisition cost and contract status drive adoption.

FERAHEME’s financial trajectory is therefore most exposed when competitors win:

• formulary status at large hospital systems
• dialysis network preferences
• payer reimbursement or step therapy arrangements

---

What financial trajectory should be modeled for FERAHEME under downside and upside cases?

A usable modeling range for FERAHEME depends on two measurable drivers:

1. Volume: treated patient counts and infusion utilization within the labeled indications.
2. Net price: contract and payer mix.

Downside scenario drivers

• increased formulary displacement by preferred IV iron products
• payer restrictions or step therapy adoption
• increased monitoring requirements raising administration friction
• margin compression through hospital contracting pressure

Upside scenario drivers

• favorable formulary refresh cycles in major systems and dialysis networks
• stable safety perception and continued clinical preference in CKD cohorts
• maintained contract pricing amid competitor disruptions

(Specific revenue forecasts cannot be produced without historical net sales, regional share, and payer contracting data.)

---

What Key Takeaways matter for investors, licensors, and litigators?

• FERAHEME’s market dynamics are driven primarily by hospital and payer contracting rather than retail channel momentum.
• Competitive displacement is most likely through formulary and reimbursement mechanisms tied to IV iron cost per treated episode and infusion convenience.
• Revenue sensitivity is concentrated in net price realization from institutional contracts and payer coverage controls.
• The generic threat hinges on Orange Book patent and exclusivity specifics plus Paragraph IV litigation outcomes; those details are not provided here, so exclusivity timing and launch calendars cannot be stated.

---

FAQs

1) What are the main factors that determine FERAHEME hospital uptake?

Institutional formulary inclusion, acquisition cost under GPO and contract terms, infusion workflow fit, and safety-management requirements.

2) Does FERAHEME face biosimilar risk?

No biosimilar pathway applies to this small-molecule iron product; the principal threat is generic or follow-on IV iron competition.

3) What competitive threats most directly pressure FERAHEME net pricing?

Preferred formulary shifts, payer step therapy, and hospital procurement tenders that reprice IV iron selection.

4) How do safety label changes typically affect revenue for IV iron drugs?

They change prescribing behavior and administrative monitoring practices, which can reduce utilization and weaken negotiating leverage with payers and institutions.

5) What are the biggest determinants of generic entry timing for FERAHEME?

Orange Book-listed patent expiration per claim scope, regulatory exclusivity periods (if any), and the presence and outcome of Paragraph IV litigation and settlements.

---

References

1. US Food and Drug Administration (FDA). Approved drug labeling and safety communications for intravenous ferumoxytol products.
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (FERAHEME entries and listed patents/exclusivities).
3. FDA. Generic Drug User Fee Amendments and Paragraph IV challenge framework (statutory basis for litigation and automatic stays).