INJECTAFER Drug Patent Profile

When do Injectafer patents expire, and when can generic versions of Injectafer launch?

Injectafer is a drug marketed by Am Regent and is included in one NDA. There are six patents protecting this drug and four Paragraph IV challenges.

This drug has seventy-one patent family members in thirty-two countries.

The generic ingredient in INJECTAFER is ferric carboxymaltose. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ferric carboxymaltose profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Injectafer

A generic version of INJECTAFER was approved as ferric carboxymaltose by MYLAN on June 25^th, 2026.

Summary for INJECTAFER

International Patents:	71
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	23
Drug Prices:	Drug price information for INJECTAFER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INJECTAFER
What excipients (inactive ingredients) are in INJECTAFER?	INJECTAFER excipients list
DailyMed Link:	INJECTAFER at DailyMed

See drug prices for INJECTAFER

Recent Clinical Trials for INJECTAFER

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

Sponsor	Phase
The First Hospital of Jilin University	PHASE1
Boji Medical Technology Co., Ltd.	PHASE1
Suzhou Guochen Biotechnology Co., Ltd.	PHASE1

See all INJECTAFER clinical trials

Pharmacology for INJECTAFER

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

Paragraph IV (Patent) Challenges for INJECTAFER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INJECTAFER	Injection	ferric carboxymaltose	500 mg/10 mL	203565	1	2024-02-22
INJECTAFER	Injection	ferric carboxymaltose	100 mg/2 mL	203565	1	2022-09-23
INJECTAFER	Injection	ferric carboxymaltose	1 g/20 mL	203565	1	2022-02-15
INJECTAFER	Injection	ferric carboxymaltose	750 mg/15 mL	203565	1	2019-03-27

US Patents and Regulatory Information for INJECTAFER

INJECTAFER is protected by twenty-six US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020		RX	Yes	Yes
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013	AP	RX	Yes	Yes
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-004	Feb 4, 2022	AP	RX	Yes	Yes
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013	AP	RX	Yes	Yes

Expired US Patents for INJECTAFER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-004	Feb 4, 2022
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-004	Feb 4, 2022
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-004	Feb 4, 2022
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013

International Patents for INJECTAFER

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

Country	Patent Number	Title	Estimated Expiration
Argentina	041472	COMPLEJOS DE CARBOHIDRATO DE HIERRO ACUOSOS SU PRODUCCION Y MEDICAMENTOS QUE LOS CONTIENEN
Austria	507246
Australia	2003278111	WATER-SOLUBLE IRON-CARBOHYDRATE COMPLEXES, PRODUCTION THEREOF, AND MEDICAMENTS CONTAINING SAID COMPLEXES
Brazil	0315452	Complexos aquosos de carboidrato de ferro, sua produção e medicamentos contendo os mesmos

Supplementary Protection Certificates for INJECTAFER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1554315	C01554315/01	Switzerland		PRODUCT NAME: EISEN ALS EISENCARBOXYMALTOSE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 57851 10.11.2022

Injectafer (ferric carboxymaltose) market dynamics and financial trajectory (sales, drivers, and near-term risk factors)

Last updated: July 27, 2026

Injectafer (iron replacement therapy; ferric carboxymaltose) has remained a high-value, branded-only product in the US based on entrenched reimbursement, infusion-center adoption, and a patent-protected formulation/method-of-use estate. The sales trajectory has been shaped by (1) expansion of hospital and outpatient infusion utilization, (2) safety and dosing convenience versus older IV iron agents, and (3) competitive pressure from other IV iron products and payer tightening around cost and infusion logistics.

What are the latest Injectafer sales trends and revenue trajectory?

Injectafer revenue is primarily driven by US and other developed-market uptake in anemia from chronic kidney disease (CKD) and iron deficiency anemia (IDA) where IV iron is used. The product is typically billed per treatment course or per administration event and is sensitive to (a) nephrology and GI anemia management patterns, (b) hospital formulary decisions, and (c) Medicare coverage behavior and commercial reimbursement.

US sales trajectory: what moves quarterly results?

Key levers that have historically moved Injectafer’s quarterly revenue include:

• Volume of IV iron administrations in hospital outpatient and infusion centers.
• Mix shift by label segment (CKD vs non-CKD IDA).
• Payer step therapy and prior authorization patterns that affect channel conversion from oral iron to IV iron.
• Competitive substitution among IV iron agents with similar indications.

How are margins shaped in the IV iron market?

Margin dynamics for branded IV iron products are typically influenced by:

• Net price erosion via rebates and payer contracting.
• Channel concentration in large infusion provider groups with strong formulary leverage.
• Inventory and supply chain cost for high-volume infusion products.
• Competitive promotional intensity from other branded IV irons and biosimilar-like substitution patterns (for supportive care).

What market drivers support Injectafer demand in iron deficiency anemia?

Injectafer’s demand base tracks the broader clinical and operational shift toward IV iron.

Clinical adoption: why clinicians prefer IV iron over oral iron

• Faster repletion and fewer clinic visits than repeated oral iron strategies.
• Reduced GI intolerance seen with oral iron.
• Standardized infusion protocols that improve workflow in infusion centers.

Where growth has come from

• Outpatient infusion expansion: shifting iron therapy into office-based and outpatient hospital settings where structured dosing pathways are common.
• Nephrology protocols: IV iron is part of CKD anemia management workflows tied to lab monitoring and dialysis unit referral patterns.
• Non-CKD IDA uptake: broader clinician use in gynecology, GI, and hematology where oral failure is common.

How does Injectafer compare with other IV iron drugs on competitive dynamics?

Competition in IV iron is largely about formulary position, dosing convenience, and safety profile in real-world use, which translate directly into utilization share.

Competitive set in practical terms

Injectafer is typically benchmarked against other IV iron agents used for IDA and CKD-related anemia, including:

• Ferric carboxymaltose competitors by class and dosing convenience.
• Other IV iron complexes with differing maximum dose per infusion and retreatment intervals.

What matters most to payers and providers

• Total course cost (drug plus administration time).
• Facility reimbursement economics (infusion duration, nursing utilization).
• Safety constraints: payer and provider policies often anchor on labeling-consistent risk management.
• Formulary exclusivity: a single preferred product can drive stepwise switching.

When does Injectafer lose exclusivity in the US (patent and regulatory exclusivity timing)?

The exclusivity timeline for Injectafer depends on its US patent estate and any regulatory exclusivity periods applicable to its approved formulations and indications. Market expectations have generally treated Injectafer as protected through a multi-year window anchored by patents covering ferric carboxymaltose compositions, formulations, and/or approved method-of-use claims.

How to interpret exclusivity risk in IV iron

For injectable iron products, generic entry risk is often limited by:

• Patent coverage on specific composition and formulation parameters.
• Patent coverage on methods of use tied to dosing regimens and indications.
• Manufacturing process constraints that can be tied to claim limitations.

What patents protect Injectafer and how strong is the patent estate?

The patent estate strength for Injectafer is measured by:

• Number of active, relevant claims (composition, formulation, and method-of-use).
• Remaining term on each jurisdiction’s key patents.
• Litigation posture and any enforcement history.

Typical claim clusters that matter commercially

• Composition of ferric carboxymaltose: foundational protection.
• Formulation and stability: parameters that can limit non-infringing generics.
• Method-of-use dosing: regimen-based claims that constrain label-aligned generic substitution.

What patent litigation or Paragraph IV challenges affect Injectafer?

Injectafer’s competitive risk profile is usually shaped by whether any generic or biosimilar-like entrants have filed ANDA Paragraph IV certifications against Orange Book-listed patents, and whether litigation resulted in settlements, injunctions, or run-at-risk launches.

What “matters” in Injectafer-specific litigation outcomes

• Whether a first challenger reached a final design-around that avoided key claims.
• Whether any settlement preserved branded market share via shared launch dates or delayed entry.
• Whether courts restricted claims in ways that shorten exclusivity in practice.

What is the Orange Book status of Injectafer (listed patents, dosage form coverage, and expirations)?

Orange Book status determines:

• Which patents are listed for each dosage form.
• Which patents are implicated by ANDA submissions.
• The practical exclusivity map that controls generic entry risk.

What to track on the Orange Book for Injectafer

• Patent list per NDC/dosage form.
• Expiration dates for each listed patent.
• Whether patents are tied to formulation or methods of use that may be hard to design around.

Which Injectafer formulations and dosages are most relevant for competition and pricing pressure?

Injectafer competes in infusion protocols where dosing convenience drives throughput.

Why dosage form matters commercially

• If alternative products offer similar total mg dosing in fewer infusions, they can displace Injectafer through operational cost and time.
• If payers restrict coverage to specific dosing patterns, competition concentrates around those exact regimens.

How does Injectafer pricing and reimbursement evolve under payer pressure?

Payer contracting has major influence on net revenue. IV iron products are especially sensitive to:

• Preferred drug lists tied to fixed budgets for anemia management.
• Rebate structures negotiated through group purchasing organizations (GPOs).
• Utilization management requiring documented failure of oral iron.

Channel impact

• Hospitals often control formularies and can shift supply contracts rapidly.
• Infusion centers respond quickly to operational benchmarks like time-per-infusion and nursing burden.
• Renal clinics can influence stability of demand by routing patients into established infusion pathways.

What commercial deals or licensing terms shape Injectafer’s market position?

For branded injectables with large distribution and payer reach, licensing and distribution arrangements affect:

• Access to inpatient and outpatient channels.
• Contracting flexibility for price concessions.
• Global availability supporting international revenue stability.

How to assess deal impact

The actionable lens is whether contractual structure:

• Supports preferred placement via rebate funding.
• Enables faster tender responses in large group purchasing settings.
• Reduces supply risk that could otherwise allow competitors to gain share.

What generic entry risks exist for Injectafer and what would generic launch scenarios look like?

Generic entry in IV iron is possible if challengers can:

• Obtain ANDA approval without infringing listed claims.
• Align manufacturing with any formulation-specific limitations.
• Negotiate payer formulary placement.

Generic launch scenarios (decision tree for market impact)

1. Early challenge with successful settlement: branded price pressure begins before final generic launch.
2. Run-at-risk entry: branded faces immediate substitution and net price decline.
3. Design-around without label changes: competition concentrates in covered indications and may broaden erosion.
4. Design-around with restricted labeling: branded retains stronger share where clinical pathways require specific dosing regimens.

Key market consequence of generic entry

• Injectafer’s gross demand may remain stable short term, but net price typically compresses quickly under competitive contracting.

How does Injectafer compare economically versus competing IV iron products for hospitals and payers?

Hospital procurement decisions usually compare:

• Net drug cost
• Administration cost and time
• Avoided re-infusion risk driven by dosing convenience
• Safety and monitoring costs

Where Injectafer typically holds up

• When dosing convenience reduces chair time or number of visits.
• When safety evidence supports consistent infusion protocols in high-throughput settings.
• When contracting makes Injectafer the preferred product for a large share of eligible patients.

What are the near-term financial risks for Injectafer?

Near-term risks generally cluster into:

• Net price erosion from payer and GPO contracting.
• Share loss to competing IV iron agents with better formulary fit.
• Exclusivity compression due to patent expiration or successful challenge outcomes.
• Safety-related label interpretation in real-world use that can alter clinical preference.

Key Takeaways

• Injectafer’s financial trajectory has been driven by stable utilization of IV iron in CKD-related and non-CKD IDA settings, supported by dosing convenience and infusion workflow fit.
• Market dynamics are dominated by payer formulary behavior, outpatient infusion growth, and competitive substitution among IV iron products.
• Commercial and patent risk centers on the Orange Book patent list, remaining active claim term, and whether any ANDA Paragraph IV challenges have led to settlements or run-at-risk entry.
• Generic entry, if it occurs, is expected to create rapid net price compression even if total IV iron demand remains resilient.

FAQs

1) What infusion center KPIs most affect Injectafer adoption?
Chair time per patient, number of visits per course, infusion protocol complexity, and staff training burden.

2) What payer utilization management tools are most common for IV iron products?
Prior authorization, oral iron failure documentation requirements, lab criteria for IDA, and preferred product tiering.

3) How do dosing convenience differences between IV irons translate into cost per treatment?
They change total administration time, re-infusion likelihood, and how often patients return for additional dosing.

4) What should be monitored for early signals of reduced Injectafer exclusivity protection?
Orange Book listed patent status changes, any Paragraph IV filings tied to those patents, and any court/settlement announcements impacting launch dates.

5) How can hospital formulary changes rapidly impact Injectafer revenue?
A shift to a preferred alternative can redirect eligible prescriptions quickly in outpatient infusion contracts and renal clinic pathways.

References

(No cited sources were provided in the prompt.)

DrugChatter Q&A for INJECTAFER

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