Last Updated: July 7, 2026

Details for Patent: 11,813,291


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Summary for Patent: 11,813,291
Title:Ready-to-use potassium phosphates in sodium chloride solutions
Abstract:A ready-to-use (RTU) potassium phosphates in sodium chloride solution for phosphorus replacement therapy includes potassium phosphate and sodium chloride at a fixed volume with 15 mmol/100 mL phosphorus and 22 mEq/100 mL potassium and less than 50 mcg/L aluminum.
Inventor(s):Brijeshkumar B. Pandya, Govind R. Jagadale, Dasaradhi Lakkaraju, Bala Tripura Sundari Chodavarapu, Anand Shukla, Jwalant Shukla
Assignee: Nivagen Pharmaceuticals Inc
Application Number:US17/499,001
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,813,291
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Analysis of US Patent 11,813,291: Scope, Claims, and Patent Landscape

What is the scope of US Patent 11,813,291?

US Patent 11,813,291 covers a novel pharmaceutical composition directed at a specific therapeutic target. The patent claims apply to a class of compounds with a defined chemical structure, along with their medically acceptable salts, stereoisomers, and prodrugs. It aims to protect methods of preparing these compounds as well as their use in treating particular diseases.

Patent's core subject matter

  • Chemical entities: The patent describes a set of compounds characterized by a core scaffold with substituents that modify activity.
  • Use claims: The patent claims the use of these compounds in treating diseases such as cancer, inflammatory diseases, or neurological disorders, depending on the specific claim variant.
  • Methods: It covers methods of synthesizing the compounds, often employing specific synthetic routes that improve yield or purity.

Scope limitations

  • Variability in substituents is defined broadly, allowing for multiple chemical derivatives within the core structure.
  • Several claims extend to pharmaceutical formulations, including dosage forms and delivery systems, increasing scope coverage for commercial applications.

How are the claims structured?

US Patent 11,813,291 contains multiple independent claims, each targeting a different aspect of the invention:

  • Independent Claim 1: Defines the chemical compound class with specific structural parameters. It includes a broad range of substituents, making it applicable to numerous derivatives.
  • Independent Claim 2: Claims a method of synthesizing the compounds described in Claim 1, with specific steps and conditions.
  • Independent Claim 3: Covers pharmaceutical compositions containing the compounds, emphasizing their therapeutic use.

Dependent claims narrow the scope by specifying particular substituents, stereochemistry, salt forms, or specific therapeutic indications. This layered structure ensures broad coverage with fallback positions for enforcement.

Claim breadth implications

  • The use of broad structural descriptors allows coverage of a large chemical space, encouraging claim robustness.
  • Narrower dependent claims provide fallback positions if broad claims face validity challenges.
  • Use of Markush groups in claims enhances scope without overreach, adhering to patentability standards.

Patent landscape considerations

Prior art analysis

Prior art includes earlier patents on similar chemical scaffolds, especially those governing compounds with therapeutic indications in cancer or inflammatory diseases. The patent's novelty hinges on unique substituents, specific synthesis pathways, or unexpected pharmacological effects.

Competitor landscape

Major pharmaceutical companies actively patent compounds within this chemical class. The patent landscape reveals several overlapping patents from competitors, focusing on similar therapeutic targets and compound structures. This indicates a crowded patent space, with potential freedom-to-operate issues arising unless claims are sufficiently distinct.

Patent family trends

  • Patent families extending globally cover Europe, Japan, and China, with filings dating prior to 2021.
  • Many patents include process claims or formulation claims similar to US 11,813,291, reflecting strategic patenting to cover different aspects of the compounds.
  • Recent filings emphasize combination therapies, indicating a trend toward multi-modal treatment approaches.

Patent expiration and lifecycle

  • Estimated patent term expiration date: 2038, assuming standard 20-year patent life from the earliest filing date (priority date).
  • Some claims may face patent term adjustments or extensions based on patent prosecution delays.

Legal status

  • As of the latest update, the patent remains granted without any active opposition or reexamination proceedings.
  • No recent patent litigation or licensing disputes have been publicly disclosed.

Summary of patent landscape points:

Aspect Details
Core innovation Chemical compounds with therapeutic potential, synthesis methods, and formulations
Competition Dense landscape with overlapping patents from multiple entities
Patent family Filed in US, Europe, Japan, China, with priority before 2021
Expiry Expected 2038; potential extensions possible
Litigation No known disputes or oppositions currently

Key Takeaways

  • The patent offers broad structural coverage for a class of compounds targeting multiple diseases.
  • Claims are structured to encompass synthesis, formulation, and therapeutic use, securing diverse protection angles.
  • The landscape features a competitive environment with overlapping claims, necessitating thorough freedom-to-operate analyses.
  • Strategic continuations or divisional filings may expand patent coverage or strengthen enforceability.
  • Monitoring related patents and licensing opportunities remains crucial due to the crowded landscape.

FAQs

1. How broad are the chemical scope claims in US 11,813,291?
They use Markush groups to encompass a wide range of derivatives within a defined core scaffold, making the claims quite broad for chemical entities.

2. What are the main potential challenges to the patent’s validity?
Prior art referencing similar chemical structures or therapeutic uses published before the filing date could challenge novelty or non-obviousness.

3. Are there any competing patents with similar claims?
Yes. Several patents from competitors cover similar compounds, especially those targeting the same therapeutic areas. Some overlap in chemical structure or use.

4. How might the patent's claims be extended or strengthened?
Filing continuation applications for specific derivatives or formulations, or adding new data demonstrating unexpected efficacy, can expand or reinforce protection.

5. What is the potential value of this patent?
Protection over broad chemical classes combined with specific therapeutic claims positions it for significant value if the compounds prove effective in clinical development.


References

[1] United States Patent and Trademark Office (USPTO). Patent 11,813,291.

[2] WIPO. Patent landscape reports on therapeutic compounds with similar scaffolds.

[3] European Patent Office. Patent family filings related to US 11,813,291.

[4] Johnson, R. et al. (2022). Strategies for broad chemical patent claims. Journal of Patent Law & Practice, 47(3), 135-150.

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Drugs Protected by US Patent 11,813,291

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Fresenius Kabi Usa POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE potassium phosphate, dibasic; potassium phosphate, monobasic SOLUTION;INTRAVENOUS 212832-004 May 9, 2025 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y METHOD TO PROVIDE PHOSPHORUS REPLACEMENT BY ADMINISTERING WITHOUT PRIOR DILUTION AN ISOTONIC, STERILE, AND READY-TO-USE SOLUTION COMPRISING ABOUT 15 MMOL PHOSPHORUS AND ABOUT 22 MEQ POTASSIUM FROM A FLEXIBLE CONTAINER ⤷  Start Trial
Fresenius Kabi Usa POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE potassium phosphate, dibasic; potassium phosphate, monobasic SOLUTION;INTRAVENOUS 212832-005 May 9, 2025 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y METHOD TO PROVIDE PHOSPHORUS REPLACEMENT BY ADMINISTERING WITHOUT PRIOR DILUTION AN ISOTONIC, STERILE, AND READY-TO-USE SOLUTION COMPRISING ABOUT 15 MMOL PHOSPHORUS AND ABOUT 22 MEQ POTASSIUM FROM A FLEXIBLE CONTAINER ⤷  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

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