ACCRUFER Drug Patent Profile

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

Accrufer is a drug marketed by Shield Tx and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-one patent family members in nineteen countries.

The generic ingredient in ACCRUFER is ferric maltol. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric maltol profile page.

DrugPatentWatch^® Generic Entry Outlook for Accrufer

Accrufer was eligible for patent challenges on July 25, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 19, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ACCRUFER

International Patents:	51
US Patents:	3
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for ACCRUFER

ACCRUFER is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW PATIENT POPULATION.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes	10,179,120
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes	9,802,973		Y	Y
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes	9,248,148

International Patents for ACCRUFER

When does loss-of-exclusivity occur for ACCRUFER?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Eurasian Patent Organization

European Patent Office

Japan

Mexico

Poland

Saudi Arabia

Singapore

South Africa

South Korea

Spain

United Kingdom

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ACCRUFER around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2015204192	Dosage regimen of ferric trimaltol
Brazil	112016015766	REGIME DE DOSAGEM DE TRIMALTOL FÉRRICO
Canada	2934836	SCHEMA POSOLOGIQUE DE TRIMALTOL FERRIQUE (DOSAGE REGIMEN OF FERRIC TRIMALTOL)
China	106413706	三麦芽酚铁的剂量方案 (Dosage regimen of ferric trimaltol)
China	114010629	三麦芽酚铁的剂量方案 (DOSAGE REGIMEN OF FERRIC TRIMALTOL)
European Patent Office	3091974	SCHÉMA POSOLOGIQUE DE TRIMALTOL FERRIQUE (DOSAGE REGIMEN OF FERRIC TRIMALTOL)
Spain	2785391

ACCRUFER (ferric maltol) Investment Scenario and Patent/Regulatory Fundamentals: Exclusivity Timeline, Generic Risk, and Commercial Exposure

Last updated: July 22, 2026

Executive summary

ACCRUFER (ferric maltol) is an oral iron therapy launched in the US for iron deficiency anemia in adults with inflammatory conditions. The investment case hinges on (1) US patent and regulatory exclusivity coverage, (2) whether generics can credibly launch via ANDA with meaningful Paragraph IV exposure, and (3) trajectory of prescriptions and reimbursement in GI- and CKD-adjacent anemia segments where oral iron is a substitution target. For investors, the core diligence questions are patent estate headroom, Orange Book status, and real-world adoption drivers versus competing oral and IV iron products.

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What patents protect ACCRUFER (ferric maltol) in the US?

Answer: ACCRUFER’s protection is built around ferric maltol composition, manufacturing/process, and crystalline or solid-state form claims, plus related method-of-use coverage for iron deficiency anemia in inflammatory states.

Core patent estate diligence checklist

1. Composition of matter: ferric maltol (active) and salt/complex coverage.
2. Solid state forms: crystalline polymorphs, hydrates/solvates, and morphology-specific claims (critical for ANDA comparability).
3. Manufacturing/process: precipitation, drying, milling, and crystallization parameter claims that can block “design-around” supply.
4. Method-of-use: dosing regimens tied to specific patient subsets (inflammatory bowel disease, chronic inflammatory conditions).
5. Regulatory exclusivity overlay: New Chemical Entity (NCE) and/or pediatric-related exclusivity only if applicable.

Jurisdictions to map for litigation leverage

• US (FDA Orange Book exclusivity and listed patents)
• EP/UK (EPO claim scope and enforcement)
• DE/FR/IT (local enforcement and injunction likelihood)
• CA/AU (export revenue sensitivity)

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When does ACCRUFER lose exclusivity in the US?

Answer: US exclusivity is the later of listed Orange Book patent expiration and any applicable regulatory exclusivity. The launch risk window for generics typically begins once the last relevant listed patent expires or is successfully challenged.

How to model the exclusivity calendar for valuation

• Patent-expiration-driven model: identify the last expiring listed patent in Orange Book tied to the approved indication and dosage form.
• Exclusivity-floor model: treat regulatory exclusivity as a floor even if patent expirations cluster earlier.
• ANDA timing model: Paragraph IV filings can pull launch earlier if a court enters a non-infringement or invalidity outcome.

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What is the Orange Book status of ACCRUFER (ferric maltol)?

Answer: ACCRUFER is listed in the FDA Orange Book with patents covering the approved drug product, including active ingredient and protected aspects (composition/solid state/process and sometimes method-of-use).

What investors should verify in Orange Book filings

• Each listed patent number and its expiration date
• Patent scope type:
  • “drug substance” (composition/complex)
  • “drug product” (formulation)
  • “method of use”
  • “intermediate”
• OTC vs prescription labeling does not apply; ACCRUFER is prescription and will have NDA/label coverage.

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How many patents cover ACCRUFER and what are the risk hotspots for generics?

Answer: The number of listed patents and the distribution across composition, form, and process determine design-around feasibility. For iron formulations, the highest generic launch friction typically comes from solid-state form and process patents that constrain the ability to match critical quality attributes.

Risk hotspots by claim type

• Solid-state form claims: generics may need to demonstrate bioequivalence using alternative polymorphs that are not covered.
• Manufacturing/process claims: even if active is the same, the producer can be blocked if the process steps fall within a protected range.
• Method-of-use claims: if strong, they push generics into “skinny label” or necessitate carve-outs to avoid infringement.

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What generic entry risks exist for ACCRUFER (ferric maltol)?

Answer: Generic entry risk is tied to whether ANDA challengers can file Paragraph IV against the dominant Orange Book patents and whether their product can avoid infringement through form/process changes while staying within FDA bioequivalence and quality requirements.

Paragraph IV pathway and what drives outcomes

• Claim construction: form/process patents often hinge on definitions of particle size, crystallinity, or preparation steps.
• Comparability testing: failure to match impurity profiles, water content, or polymorph signatures can undermine bioequivalence strategy.
• Injunction likelihood: if a court finds likely infringement and the patentee has clean claim scope, launch can be blocked even after a settlement.

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Which companies are challenging ACCRUFER with Paragraph IV ANDAs?

Answer: The competitive ANDA challenger set and filing history determine near-term launch timelines. For high-precision diligence, the key is the identity of Paragraph IV filers and the specific patents challenged.

What should be mapped in an investment memo

• Paragraph IV filers’ identity and their legal theories
• Patents asserted and whether challenges include the last expiring ones
• Whether the patentee won on preliminary injunction or reached settlement before ruling

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What ACCRUFER formulation patents matter for bioequivalence and design-around?

Answer: For ACCRUFER, investor-relevant formulation protection typically includes solid-state and manufacturing claims rather than excipient-only changes. Generics often must reproduce the protected solid-state profile to achieve consistent dissolution and exposure.

Formulation diligence parameters

• Particle size distribution and milling parameters (if claimed)
• Hydration state (hydrate/solvate definitions)
• Impurity acceptance and control strategy (if patents claim specific impurity limits or preparation routes)

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How does ACCRUFER compare with competing oral iron products and IV iron therapies?

Answer: ACCRUFER competes with oral iron formulations (ferrous salts, polysaccharide iron complexes, other iron formulations) and indirectly with IV iron in patients who need faster correction or cannot tolerate oral iron.

Competitive positioning drivers

• GI tolerability: oral iron adherence depends on fewer adverse GI events.
• Dosing schedule: once or fixed dosing affects persistence.
• Efficacy in inflammatory states: uptake depends on hepcidin modulation and tolerability.

Competitive set mapping for commercial diligence

• Oral iron: ferrous sulfate and related salts (high price pressure, GI AE burden)
• Oral complexed iron: polysaccharide iron complexes and other iron formulations
• IV iron: ferric carboxymaltose, ferric derisomaltose, iron sucrose (payer preference depends on infusion access and tolerability)

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What patent litigation affects ACCRUFER investment timing?

Answer: The valuation schedule is driven by whether ACCRUFER’s dominant patents are under active litigation, whether courts grant injunctions, and whether settlements cap exposure.

Litigation milestones investors track

• Complaint filing dates
• Markman (claim construction) outcomes
• Preliminary injunction motions and rulings
• Trial schedules
• Settlement agreements converting infringement risk into launch-cap timelines

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What settlement agreements can delay or accelerate ACCRUFER generic launches?

Answer: Settlements that include “reverse payment” style terms or agreed launch dates can shift entry beyond the theoretical patent expiry date. If settlements allow earlier entry with design-around products, the risk window compresses.

How to incorporate settlements into forecasts

• Separate:
  • “hard blocking” patents (infringement findings)
  • “agreed entry” events (settlement launch dates)
• Treat each ANDA as a separate launch option with its own earliest date.

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What is the FDA regulatory status of ACCRUFER and what does it imply for competitors?

Answer: ACCRUFER is an FDA-approved NDA product with an approved label for iron deficiency anemia in adults with inflammatory conditions. Regulatory status affects what generics must demonstrate for approval: product sameness or bioequivalence, and label carve-out constraints if necessary.

Investor-relevant regulatory dimensions

• NDA holder changes and label updates
• Any safety communications that could impair adoption
• Changes to dosing recommendations that could alter generic comparability strategy

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How strong is the patent estate for ACCRUFER versus similar iron drugs?

Answer: Strength is measured by (1) whether the remaining claims are broad on composition/form/process, (2) whether multiple patents share the same expiration, and (3) whether litigation outcomes historically support enforceability for the listed claims.

Benchmarks investors typically use

• Number of independent claims that are likely to survive validity challenges
• Claim overlap across jurisdictions (US and EP influence settlement power)
• Whether the last expiring claims are composition/form rather than easily design-around excipients

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Commercial fundamentals: what drives ACCRUFER revenue sensitivity?

Answer: ACCRUFER’s revenue sensitivity is concentrated in adoption and persistence among target anemia populations and payer coverage decisions, with second-order sensitivity to pricing and competition from oral iron alternatives and IV iron substitution.

Key fundamentals to model

• Prescriptions and share in inflammatory anemia categories
• Net price and rebate structure (payer contracting)
• Persistence and adherence (GI tolerability reduces dropout)
• Switching behavior versus IV iron (site of care constraints)

Revenue risk map for investors

• Near-term: uptake velocity, payer restrictions, competitor formulary wins
• Medium-term: generic/alternate product substitution if patent headroom narrows
• Longer-term: label expansions can extend addressable market; label restrictions reduce it

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Investment scenario: bull, base, and bear pathways for ACCRUFER

Answer: The scenario analysis should tie each outcome to a single commercial variable and one legal/regulatory variable.

Base case

• Continued adoption with stable payer access
• Patent estate holds through most of the remaining term with no successful launch challenge

Bull case

• Stronger-than-expected persistence and guideline-aligned use
• Litigation and Orange Book challenges fail, extending exclusivity and protecting price

Bear case

• ANDA challenger design-around succeeds on key patents, shrinking the protected window
• Erosion from oral competition accelerates as formulary pressure increases and generic risk materializes

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Key Takeaways

• ACCRUFER’s investment profile is driven by the remaining US Orange Book-listed patent set, including form/process and any method-of-use claims.
• Generic launch risk depends on whether ANDA challengers can prevail on the last expiring listed patents or reach favorable settlement terms.
• Commercial durability depends on adoption in inflammatory anemia populations, GI tolerability-driven persistence, and payer coverage that limits substitution toward cheaper oral iron or infusions.

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FAQs

1) What dosage forms of ACCRUFER are most likely to face direct generic substitution risk?
Oral solid dosage forms are evaluated for bioequivalence, so generics that can reproduce the protected solid-state profile face the lowest approval friction.

2) Can generics launch with a skinny label for ACCRUFER’s method-of-use?
They can attempt to carve out protected uses if method-of-use claims are the infringement pivot, but regulatory and infringement outcomes depend on claim scope and label matching.

3) How do solid-state form patents change ANDA comparability for iron drugs?
They can force challengers into specific polymorph or particle-size strategies to match exposure and quality attributes, raising design-around and litigation complexity.

4) Does ACCRUFER’s competition from IV iron change patent strategy for challengers?
Yes. If payers steer to IV iron, generic oral adoption may matter less, but challengers still pursue ANDA approvals because oral iron substitution can reappear when IV access or cost shifts.

5) What investor signals predict an earlier-than-expected generic entry?
A strong combination of early Paragraph IV filings targeting the last expiring patents and adverse court or settlement terms that permit earlier launch.

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References

1. FDA Orange Book. ACCRUFER (ferric maltol) (US). US Food and Drug Administration.
2. US Patent and Trademark Office (USPTO). Patent full text and bibliographic data for ACCRUFER-related assignees and claims.
3. FDA. Drug approvals and labeling for ACCRUFER (ferric maltol). US Food and Drug Administration.