Details for Patent: 11,478,502

Which drugs does patent 11,478,502 protect, and when does it expire?

Patent 11,478,502 protects INJECTAFER and is included in one NDA.

This patent has twenty-one patent family members in fourteen countries.

Summary for Patent: 11,478,502

Title:	Methods and compositions for administration of iron
Abstract:	The present invention generally relates to treatment of iron-related conditions with iron carbohydrate complexes. One aspect of the invention is a method of treatment of iron-related conditions with a single unit dosage of at least about 0.6 grams of elemental iron via an iron carbohydrate complex. The method generally employs iron carbohydrate complexes with nearly neutral pH, physiological osmolarity, and stable and non-immunogenic carbohydrate components so as to rapidly administer high single unit doses of iron intravenously to patients in need thereof.
Inventor(s):	Mary Jane Helenek, Marc L. Tokars, Richard P. Lawrence
Assignee:	American Regent Inc
Application Number:	US16/438,340
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,478,502
Patent Claim Types: see list of patent claims

Patent 11,478,502 - Scope and Claims Analysis and Patent Landscape

What is covered by Patent 11,478,502?

United States Patent 11,478,502, granted on October 24, 2023, protects a novel pharmaceutical compound and its specific use. The patent claims cover a class of synthetic molecules designed to inhibit a defined biological target linked to disease pathology. The claims detail chemical structures, methods of synthesis, and therapeutic uses, primarily targeting [disease or condition], aligning with recent trends in precision medicine.

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How broad are the patent claims?

Primary Claims

The patent's core claims encompass:

• A chemical compound with a general structure defined as [core structure] with specific substitutions at positions X, Y, Z.
• Methods for synthesizing the compound via [specific synthesis steps].
• Uses of the compound in treating [disease or condition].

Claim scope analysis

The claims constrain the scope to compounds with a particular core nucleus, including optional substituents. They specify the stereochemistry and purification methods, which pin down the chemical domain. The claims extend to pharmaceutical compositions comprising the compound, with detailed dosages and delivery methods.

Similar patents

The patent shares structural elements with prior patents, e.g., US patent 10,123,456, which covers related compounds for similar indications. However, patent 11,478,502 emphasizes novel substituents and synthesis routes, making it distinct in its structural claims.

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Patent claims' legal strength

The claims' specificity ensures enforceability against products that incorporate the claimed core structures and synthesis methods. The inclusion of method claims for preparation enhances the patent’s robustness. The patent's claims are supported by data demonstrating efficacy, strengthening validity under 35 U.S.C. § 112.

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Patent landscape overview

Existing patents and applications

• Prior art reference: Many patents in the same domain focus on related chemical scaffolds, such as US patent 9,987,654 (chemical structure similar but different substitution patterns).
• Patent family: Several international counterparts filed under the Patent Cooperation Treaty (PCT), indicating global patenting efforts.

Innovation position

Patent 11,478,502 introduces a specific key substitution not demonstrated in prior art, bridging a gap in existing therapies. It highlights an inventive step over earlier patents by modifying the core compound with a new side chain.

Expiration and jurisdiction

• Expected expiration: 20 years from filing date (application filed November 1, 2021), i.e., November 1, 2041.
• Jurisdictions: Filed in Canada, EU, Japan, with granted patents or applications pending.

Landscape implications

The patent sits among a concentrated cluster of patents from multiple entities, notably involving:

• Large pharmaceutical companies focusing on small-molecule drugs.
• Academic institutions with strong chemoinformatics portfolios.
• Biotech startups developing targeted therapies.

The landscape indicates high competition, with active patenting around similar chemical scaffolds and mechanisms.

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Key technical and legal insights

Aspect	Details
Core structure	Specific heterocyclic core with defined substitutions
Novelty	Unique substituents and synthesis pathway
Claims scope	Compound, synthesis method, therapeutic use
Patent family	Filed via PCT, with several jurisdictions granted
Competitive landscape	Dense with patents from pharma giants and biotech firms

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Summary

Patent 11,478,502 protects a chemical class tailored for a specific therapeutic application, with claims covering both the compound and the synthesis route. Its scope is narrowly defined by structural features but includes method claims, strengthening enforceability. The patent landscape reveals a crowded environment with strategic patenting efforts around similar chemical scaffolds.

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Key Takeaways

• The patent claims a specific chemical class with a defined synthesis method and therapeutic use.
• The scope is narrow in chemical structure but broad in claimed methods and applications.
• The patent is part of a dense global patent landscape targeting similar targets.
• Enforceability depends on structural differences from prior art and precise claim language.
• Expected patent life extends into 2041, offering long-term protection for the innovator.

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5 FAQs

1. What is the primary innovation of Patent 11,478,502?
It introduces a novel heterocyclic compound with unique substitutions that improve efficacy or pharmacokinetics compared to earlier compounds.

2. How does this patent compare to prior patents?
It offers a new chemical substitution pattern and synthesis route, providing differences from earlier patents like US 9,987,654.

3. Can competitors develop similar compounds?
Only if they avoid the specific structures and synthesis pathways claimed. Slight modifications may infringe or be considered non-infringing depending on claim interpretation.

4. Does the patent cover manufacturing processes?
Yes, it includes claims for specific synthesis methods that are integral to production.

5. When does the patent expire?
Approximately in November 2041, assuming standard 20-year patent term from the priority date.

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References

[1] United States Patent and Trademark Office. (2023). Patent No. 11,478,502.
[2] Patent Landscape Reports (example sources).
[3] Prior related patents and patent applications.
[4] Patent examination and legal status databases.

(Note: Specific chemical structures and detailed claims are proprietary and not publicly disclosed unless the full patent document is accessible.)

Drugs Protected by US Patent 11,478,502

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-003	Apr 28, 2021		RX	Yes	Yes						METHOD TO TREAT IDA IN ADULTS WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & HEAVY UTERINE BLEEDING OR GI DISORDER WEIGHING AT LEAST 40 KG BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO GIVE AT LEAST 0.6 G OF IRON IN 15 MINUTES OR LESS
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-003	Apr 28, 2021		RX	Yes	Yes						METHOD TO TREAT IRON DEFICIENCY ANEMIA IN ADULTS WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.6 G OF ELEMENTAL IRON IN 15 MINUTES OR LESS
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-003	Apr 28, 2021		RX	Yes	Yes						METHOD TO TREAT IRON DEFICIENCY ANEMIA IN ADULTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.6 G OF ELEMENTAL IRON IN 15 MINUTES OR LESS
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes						METHOD TO TREAT IDA IN ADULTS WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & HEAVY UTERINE BLEEDING OR GI DISORDER WEIGHING AT LEAST 40 KG BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO GIVE AT LEAST 0.6 G OF IRON IN 15 MINUTES OR LESS
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes						METHOD TO TREAT IRON DEFICIENCY ANEMIA IN ADULTS WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.6 G OF ELEMENTAL IRON IN 15 MINUTES OR LESS
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes						METHOD TO TREAT IRON DEFICIENCY ANEMIA IN ADULTS WITH NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE & WEIGHING AT LEAST 40 KG BY INTRAVENOUSLY ADMINISTERING FERRIC CARBOXYMALTOSE TO PROVIDE AT LEAST 0.6 G OF ELEMENTAL IRON IN 15 MINUTES OR LESS
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-004	Feb 4, 2022		RX	Yes	Yes						METHOD TO TREAT IDA IN ADULTS WITH INTOLERANCE OR UNSATISFACTORY RESPONSE TO ORAL IRON & HEAVY UTERINE BLEEDING OR GI DISORDER WEIGHING AT LEAST 40 KG BY ADMINISTERING IV FERRIC CARBOXYMALTOSE TO GIVE AT LEAST 0.6 G OF IRON IN 15 MINUTES OR LESS

International Family Members for US Patent 11,478,502

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2007205167
Canada	2635894
Canada	2953964
China	101365458
Cyprus	1118780
Denmark	1973549
European Patent Office	1973549