US Patent 10,179,120: Ferric Trimaltol Treatment Claims, Patent Scope, and Generic Entry Risk

US Patent No. 10,179,120 protects a dosing regimen for oral ferric trimaltol, also known as ferric maltol, in iron deficiency associated with active inflammation. Its strongest protection is a combined method claim requiring a specific 30 mg elemental-iron dose, twice-daily administration on an empty stomach, an inflammatory-disease setting, and a formulation containing at least 60% ferric trimaltol by combined active-and-excipient weight. The patent does not broadly claim every ferric trimaltol formulation or every treatment of iron deficiency.

The patent was issued January 15, 2019, to Shield TX (UK) Limited. Its anticipated US expiration is June 17, 2031, subject to any applicable patent-term adjustment or disclaimer reflected in the USPTO record. The patent is relevant to Accrufer, the FDA-approved ferric maltol product marketed by Shield Therapeutics under NDA 212728.[1][2]

What does US Patent 10,179,120 cover?

The patent covers methods of treating iron deficiency, with or without anemia, where the deficiency results from or is associated with active inflammatory disease or active acute or chronic inflammation.

The independent claims impose the following limitations:

Limitation	Claim 1	Claim 11
Active ingredient	Ferric trimaltol	Ferric trimaltol
Elemental iron dose	30 mg	30 mg
Route	Oral	Oral
Administration frequency	Twice daily	Twice daily
Timing	Empty stomach	Empty stomach, once before breakfast and once before sleep
Formulation threshold	At least 60% ferric trimaltol of active plus excipients	Same
Disease context	Iron deficiency with or without anemia associated with active inflammation	Same
Treatment duration	Not required in claim 1	Up to 12 weeks
Capsule size	Not required in claim 1	Size 1 capsule
IBD limitation	Not required in claim 1	Not expressly required
Specific excipient formula	Not required in claim 1	Not expressly required

Claim 1 is the primary independent method claim. Claim 11 is a narrower, more commercially specific regimen that tracks a defined capsule, schedule, and induction period.

The patent is therefore a treatment-method patent with formulation and dosing limitations. It is not, standing alone, a broad composition patent covering ferric trimaltol as a chemical entity.

How broad is the scope of claim 1?

Claim 1 has meaningful commercial scope but several cumulative limitations. An accused product or treatment must satisfy every limitation, either literally or under an applicable doctrine-of-equivalents analysis.

Disease limitation

The patient must have iron deficiency with or without anemia that is a result of, or associated with:

Active inflammatory disease;
Active acute inflammation; or
Active chronic inflammation.

The claim is not limited to inflammatory bowel disease. It can cover other inflammatory settings if the iron deficiency is causally associated with active inflammation. Claims 2 through 4 narrow the protection to iron deficiency anemia in inflammatory bowel disease, including Crohn's disease and ulcerative colitis.

A treatment for uncomplicated nutritional iron deficiency, blood-loss anemia without an inflammatory association, or iron deficiency unrelated to active inflammation would fall outside the express scope of claim 1.

Dose limitation

The required dose is 30 mg of elemental iron per administration. A regimen using 15 mg, 45 mg, 60 mg, or another dose would not literally meet the 30 mg limitation.

The claim is directed to the elemental iron content, not merely the gross weight of ferric trimaltol. The patent's formulation example contains 231.5 mg of ferric trimaltol corresponding to 30 mg elemental iron.

Twice-daily administration

Claim 1 requires administration twice daily. Claim 11 specifies once before breakfast and once before sleep. A once-daily regimen is outside claims 1 and 11 but may implicate claim 7 if it is used after the initial 12-week period and otherwise satisfies the claim structure.

The schedule limitation creates a meaningful design-around opportunity. A product labeled only for once-daily administration would present a lower literal-infringement risk, although physician or patient use under a different regimen can create separate inducement or contributory-liability issues.

Empty-stomach limitation

The drug must be administered on an empty stomach. Claim 11 adds specific timing: one dose before breakfast and one dose before sleep.

A label that directs administration with food would not literally practice this limitation. A label that permits administration with or without food could create a more complex infringement analysis, depending on whether the approved instructions encourage the claimed empty-stomach use.

Formulation concentration limitation

Ferric trimaltol must represent at least 60% of the combined weight of ferric trimaltol and excipients.

This limitation is calculated as:

[ \frac{\text{weight of ferric trimaltol}}{\text{weight of ferric trimaltol + excipients}} \times 100 ]

For claim 10:

Ferric trimaltol: 231.5 mg
Lactose monohydrate: 91.5 mg
Sodium lauryl sulfate: 3.0 mg
Crospovidone: 9.0 mg
Colloidal silicon dioxide: 0.6 mg
Magnesium stearate: 3.0 mg
Total capsule weight: 338.6 mg
Ferric trimaltol percentage: approximately 68.4%

The example therefore exceeds the 60% threshold.

The percentage calculation excludes other capsule components that are not classified as excipients in the claim language. A generic developer would need to evaluate the precise formulation accounting methodology, including capsule shell material and any coating or processing substances.

What formulations are protected by US 10,179,120?

Claim 10 specifically covers a size 1 capsule containing:

Component	Amount per capsule
Ferric trimaltol	231.5 mg
Lactose monohydrate	91.5 mg
Sodium lauryl sulfate	3.0 mg
Crospovidone	9.0 mg
Colloidal silicon dioxide	0.6 mg
Magnesium stearate	3.0 mg

Claim 10 depends on claim 9, which depends on claim 1. The composition is therefore protected only when used in the claimed inflammatory-disease treatment method. Claim 10 is not a free-standing composition claim.

A capsule with a different excipient system may avoid claim 10 while still infringing claim 1 if it:

Contains ferric trimaltol at or above the 60% threshold;
Delivers 30 mg elemental iron;
Is administered twice daily;
Is taken on an empty stomach; and
Treats inflammation-associated iron deficiency.

Changing lactose, sodium lauryl sulfate, crospovidone, or lubricant levels does not necessarily avoid claim 1. It may avoid claim 10 if the exact formulation is materially different.

Which claims cover inflammatory bowel disease?

Claims 2 through 4 create disease-specific fallbacks:

Claim	Protected disease setting
Claim 2	Iron deficiency anemia in inflammatory bowel disease
Claim 3	Crohn's disease
Claim 4	Ulcerative colitis

These claims require the limitations of claim 1 and then add the IBD limitation. They do not cover all iron deficiency in Crohn's disease or ulcerative colitis. The claimed treatment must still use the 30 mg elemental iron ferric trimaltol regimen twice daily on an empty stomach and satisfy the 60% formulation threshold.

The IBD claims may be commercially important because oral iron treatment in active IBD is a defined clinical use case. They also provide narrower positions for enforcement if a broader claim is challenged for anticipation or obviousness.

How do claims 5 through 8 affect maintenance dosing?

Claims 5 through 8 expand the regimen architecture beyond the initial twice-daily treatment.

Claim 5: specific daily timing

Claim 5 requires one dose before breakfast and one dose before sleep. This is narrower than claim 1 and is most relevant to product labeling or clinical protocols that expressly use those time points.

Claim 6: up to 12 weeks

Claim 6 limits the twice-daily 30 mg regimen to a period of up to 12 weeks. It may cover an induction course lasting less than or equal to 12 weeks.

Claim 7: post-induction dosing

Claim 7 covers a subsequent oral ferric trimaltol regimen after the 12-week period. The maintenance dose may contain 30 mg to 120 mg elemental iron and may be administered:

Once daily;
Once every two days;
Once every three days;
Once every four days;
Once every five days;
Once every six days; or
Once every seven days.

The claim requires the preceding 12-week regimen from claim 6. A maintenance regimen used without the claimed initial course would not literally satisfy claim 7.

Claim 8: indefinite maintenance

Claim 8 covers indefinite administration of the 30 mg twice-daily preparation as a maintenance dose. This is broader in duration than claim 6 but retains the core regimen and disease limitations of claim 1.

What is the difference between claims 1 and 11?

Claim 1 is broader in treatment duration and dosage timing. Claim 11 is narrower but more closely aligned with a commercial product protocol.

Issue	Claim 1	Claim 11
Twice daily	Yes	Yes
Empty stomach	Yes	Yes
Before breakfast and before sleep	No express requirement	Yes
Up to 12 weeks	No	Yes
Size 1 capsule	No	Yes
30 mg elemental iron	Yes	Yes
60% ferric trimaltol threshold	Yes	Yes
Active inflammation	Yes	Yes

Claim 11 may be easier to map against a product label if the label expressly states the claimed timing, capsule size, and 12-week course. Claim 1 may be more difficult to design around because it does not require a 12-week duration or a size 1 capsule.

When does US Patent 10,179,120 lose exclusivity?

The patent's anticipated expiration date is June 17, 2031, based on the earliest priority framework associated with the patent family and the standard 20-year US patent term.[1]

The patent provides patent-based protection only until expiration, subject to the legally effective term shown in the USPTO patent record. It is separate from FDA regulatory exclusivity.

The key US exclusivity timeline is:

Event	Date
Earliest claimed priority	June 18, 2010
US patent grant	January 15, 2019
Anticipated patent expiration	June 17, 2031
Accrufer FDA approval	July 25, 2019
NDA	212728

FDA approval and patent expiration operate independently. A generic applicant may file an ANDA before patent expiration and certify to the listed patents, but commercial launch can remain restricted by litigation, a statutory stay, settlement terms, or other listed patents.[2][3]

What is the Orange Book status of Accrufer?

Accrufer is the relevant FDA-approved ferric maltol product. The FDA approved ferric maltol capsules under NDA 212728 for treatment of iron deficiency in adults.[2]

US Patent 10,179,120 is part of the patent estate associated with the ferric maltol product and its approved treatment regimen. The Orange Book is the operative source for current patent listings, use codes, delisting events, and pediatric-exclusivity information.[3]

For generic-entry analysis, an ANDA applicant must assess:

Whether US 10,179,120 is listed against the relevant NDA;
The listed use code;
Whether the proposed label would practice the patented method;
Whether a Paragraph IV certification is appropriate;
Whether a section viii statement can carve out the patented indication; and
Whether other Accrufer patents independently block launch.

The patent's method-of-use character creates a potential section viii strategy if the generic label can omit the patented inflammatory-disease indication and avoid instructions for the claimed dosing regimen. That strategy becomes less effective if the listed use code covers the product's principal approved use or if the proposed label still encourages the patented method.

Which companies are challenging US 10,179,120?

No broadly reported, final federal-court judgment invalidating US 10,179,120 or authorizing an at-risk generic launch has established a public market outcome for this patent. Public generic-entry analysis should distinguish between:

A Paragraph IV certification;
A notice letter;
A filed Hatch-Waxman lawsuit;
A settlement;
A final judgment; and
An FDA-approved ANDA.

A Paragraph IV notice alone does not invalidate the patent. If the NDA holder sues within 45 days, the FDA generally applies a 30-month stay to approval of the ANDA, subject to statutory exceptions and court action.[4]

The absence of an identified final challenge outcome means US 10,179,120 remains a live patent barrier through its stated expiration date unless invalidated, disclaimed, or otherwise removed from the relevant Orange Book listing.

What patent litigation affects ferric maltol?

The principal litigation risks are likely to arise through a Hatch-Waxman action based on an ANDA certification rather than conventional product-liability litigation.

Potential causes of action include:

Literal infringement of claim 1 through a label directing 30 mg twice-daily dosing on an empty stomach;
Literal infringement of claim 11 through a size 1 capsule and the before-breakfast/before-sleep schedule;
Induced infringement based on a generic label or promotional material;
Infringement of claim 10 through the specified capsule formulation;
Invalidity based on anticipation or obviousness;
Noninfringement based on a different dose, formulation, timing instruction, or indication; and
Section viii carve-out disputes involving the inflammatory-disease use.

The core validity issues would likely focus on whether prior art disclosed the combination of ferric trimaltol, the 30 mg elemental iron dose, empty-stomach twice-daily dosing, the 60% formulation threshold, and treatment of inflammation-associated iron deficiency.

How strong is the patent estate for ferric maltol?

US 10,179,120 has moderate-to-strong commercial relevance because it combines several features that can be difficult for an ANDA applicant to avoid simultaneously:

The Accrufer active ingredient;
A commercially relevant 30 mg elemental iron strength;
A defined twice-daily regimen;
Empty-stomach administration;
Inflammatory-disease treatment;
A high active-to-excipient ratio; and
A formulation concentration linked to a capsule product.

Its limitations also create invalidity and design-around vulnerabilities. The claim is not compositionally broad. It does not prevent all ferric trimaltol products, all 30 mg products, or all oral iron therapies. A competing product may reduce risk by changing the label, dose, administration frequency, indication, formulation ratio, or excipient system.

The strongest enforcement position is likely against a product whose labeling reproduces the claimed regimen for patients with active inflammatory disease. The weaker position is against a product marketed for general iron deficiency with once-daily dosing and no inflammatory-disease indication.

How does US 10,179,120 compare with other ferric maltol protections?

Ferric maltol protection generally falls into four categories:

Protection category	Relevance to US 10,179,120
Chemical entity or active complex	Not the primary focus
Formulation composition	Narrowly included through dependent claim 10
Dose and administration regimen	Central focus of claims 1 and 11
Disease-specific method of use	Central focus, especially active inflammation and IBD

A complete freedom-to-operate analysis must review the full Shield Therapeutics and ferric maltol family, including composition, manufacturing, formulation, clinical-use, and regulatory patents. US 10,179,120 should not be treated as the only relevant patent merely because it directly recites the commercial dosing regimen.

The principal non-patent barriers are manufacturing know-how, regulatory exclusivity, product-specific analytical methods, clinical data, and supply-chain control over ferric maltol production. These barriers do not extend patent life but can affect the timing and cost of generic entry.

What generic launch scenarios exist?

Scenario 1: Label carve-out

A generic applicant could attempt to omit the inflammatory-disease indication or the claimed dosing instructions under a section viii statement. This approach depends on the precise Orange Book use code and the remaining approved indications.

Scenario 2: Noninfringing regimen

A proposed label could use once-daily dosing, administration with food, a different elemental iron strength, or a different treatment population. Each change must be assessed against the full patent claim set and other patents.

Scenario 3: Paragraph IV litigation

An ANDA applicant could assert that the patent is invalid, not infringed, or unenforceable. A timely suit may delay approval for up to 30 months, subject to statutory exceptions.

Scenario 4: Post-expiration launch

Absent earlier invalidation, settlement, license, or court relief, a generic could launch after the patent's effective expiration date. Other listed Accrufer patents could still affect launch timing.

Scenario 5: At-risk launch

A generic applicant could launch before final resolution of patent litigation. That strategy exposes the applicant to damages, possible injunctive relief, and treble-damages risk for willful infringement.

What licensing deals affect ferric maltol?

Shield Therapeutics has commercialized Accrufer in the United States and has used regional commercial partnerships for ferric maltol. Publicly disclosed agreements involving Shield and regional partners affect commercial rights, but a license or distribution agreement does not by itself establish freedom from US patent enforcement.

The relevant distinction is:

A commercial license may authorize marketing;
A patent license may authorize practicing patent claims; and
A distribution agreement may provide no patent authorization.

Commercial counterparties should verify whether any agreement expressly grants rights under US 10,179,120, related US patents, or the underlying patent family.

What is the geographic coverage of the patent?

US 10,179,120 provides rights only in the United States and its territories. Corresponding foreign patents or applications may exist in Europe, the United Kingdom, Canada, Australia, and other jurisdictions, but their claim scope, prosecution history, expiration dates, opposition outcomes, and enforceability are independent.

A US noninfringement position does not establish freedom to operate in Europe or other markets. Foreign analysis should review national-phase members, granted claims, supplementary protection certificates, patent-term adjustments, and local litigation.

Key Takeaways

US 10,179,120 is a method-of-treatment patent for ferric trimaltol in iron deficiency associated with active inflammation.
Claim 1 requires 30 mg elemental iron, oral twice-daily dosing, empty-stomach administration, and a formulation containing at least 60% ferric trimaltol by combined active-and-excipient weight.
Claims 2 through 4 target inflammatory bowel disease, Crohn's disease, and ulcerative colitis.
Claim 10 recites a specific size 1 capsule and excipient composition but remains dependent on the treatment-method limitations.
Claim 11 closely tracks a commercial 12-week, twice-daily dosing regimen.
The anticipated patent expiration is June 17, 2031.
FDA approval of Accrufer under NDA 212728 does not eliminate the patent barrier.
Generic applicants may evaluate section viii carve-outs, Paragraph IV certifications, alternative dosing, different labels, and formulation design-arounds.
The patent is commercially meaningful but does not broadly cover all ferric trimaltol products or all oral treatment of iron deficiency.
Other ferric maltol patents, Orange Book listings, settlement terms, and manufacturing rights must be reviewed before a launch or licensing decision.

FAQs

Does US 10,179,120 cover Accrufer itself?

It covers methods of using ferric trimaltol under specified dosing, formulation, timing, and inflammatory-disease conditions. It is not a broad composition claim covering every Accrufer capsule independent of use.

Can a generic ferric maltol product launch with once-daily dosing?

Once-daily dosing may avoid the twice-daily limitation in claim 1, but claims 7 and 8 and other ferric maltol patents must also be assessed. The generic label and actual promoted use are critical.

Does changing the capsule excipients avoid infringement?

Changing excipients may avoid claim 10 if the specified composition is not reproduced. It will not necessarily avoid claim 1 if the revised formulation still meets the 60% ferric trimaltol threshold and the treatment regimen remains the same.

Is ferric trimaltol the same active ingredient as ferric maltol?

Ferric trimaltol is commonly used as the chemical description of ferric maltol, the iron complex in Accrufer. Regulatory and patent analyses should use the ingredient nomenclature in the applicable FDA records and patent claims.

Can a company sell ferric trimaltol for non-inflammatory iron deficiency before 2031?

Potentially, but the product must be assessed against the full patent estate, not only US 10,179,120. A non-inflammatory indication may avoid the disease limitation in this patent while remaining subject to composition, formulation, manufacturing, or other method-of-use patents.

References

United States Patent and Trademark Office. (2019). U.S. Patent No. 10,179,120, Treatment of iron deficiency.
U.S. Food and Drug Administration. (2019). Accrufer approval letter and prescribing information, NDA 212728.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
U.S. Food and Drug Administration. (2023). Abbreviated new drug application approvals and patent certifications under the Hatch-Waxman Amendments.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Shield Tx	ACCRUFER	ferric maltol	CAPSULE;ORAL	212320-001	Jul 25, 2019		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				METHOD OF TREATING IRON DEFICIENCY	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	1400171.3	Jan 6, 2014
United Kingdom	1418708.2	Oct 21, 2014

PCT Information
PCT Filed	January 06, 2015	PCT Application Number:	PCT/IB2015/050098
PCT Publication Date:	July 09, 2015	PCT Publication Number:	WO2015/101971

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015204192	⤷ Start Trial
Brazil	112016015766	⤷ Start Trial
Canada	2934836	⤷ Start Trial
China	106413706	⤷ Start Trial
China	114010629	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Summary for Patent: 10,179,120