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Last Updated: December 22, 2024

Details for Patent: 7,816,404


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Summary for Patent: 7,816,404
Title:Methods for the preparation and use of ferric pyrophosphate citrate chelate compositions
Abstract: A highly water soluble ferric pyrophosphate citrate chelate useful for treating iron deficiency contains 2% or less phosphate by weight. These chelate compositions are easily milled and/or processed into dosage forms using conventional techniques, and are expected to exhibit advantageous biocompatibility as compared to conventional soluble ferric pyrophosphates, ferric salts, ferric polysaccharide complexes and ferrous salts.
Inventor(s): McCall, Jr.; William S. (Raleigh, NC)
Assignee: Rockwell Medical Technologies, Inc. (Wixom, MI)
Application Number:12/138,018
Patent Claim Types:
see list of patent claims
Composition; Process; Use; Dosage form;
Patent landscape, scope, and claims:

United States Patent 7,816,404: A Detailed Analysis of Scope and Claims

Introduction

The United States Patent 7,816,404, titled "Methods for the preparation and use of ferric pyrophosphate citrate chelate compositions," is a significant patent in the field of pharmaceuticals and nutritional supplements. This patent, granted to inventors for their innovative method of preparing a highly water-soluble ferric pyrophosphate citrate chelate, is crucial for understanding the patent landscape in this area.

Patent Overview

Publication Number and Authority

The patent number is US7816404B2, and it was granted by the United States Patent and Trademark Office (USPTO)[4].

Prior Art and Background

The patent builds on prior art related to ferric pyrophosphate and citrate compositions. It addresses the need for a highly water-soluble iron chelate that can be used effectively in various medical and nutritional applications.

Claims

The patent includes multiple claims that define the scope of the invention. Here are some key claims:

  • Claim 1: A method for preparing a ferric pyrophosphate citrate chelate composition, involving the reaction of ferric ions with citrate and pyrophosphate anions.
  • Claim 2: The composition resulting from the method, characterized by its high water solubility and specific ratio of iron to citrate to pyrophosphate.
  • Claim 3: The use of the chelate composition as a food supplement, dietary supplement, nutritive supplement, or medical food.
  • Claim 4: The administration of the chelate composition either orally or by injection for treating iron deficiency[4].

Scope of the Invention

Composition and Preparation

The patent describes a method for preparing a ferric pyrophosphate citrate chelate composition that is highly water-soluble. This involves mixing ferric ions with citrate and pyrophosphate anions under specific conditions, such as controlling the ratio of the reactants, the volume of water, the reaction temperature, and the use of organic solvents for precipitation[4].

Key Parameters

Several parameters are critical for the preparation and quality of the chelate composition:

  • Ratio of Iron to Citrate to Pyrophosphate: This ratio affects the product yield and quality.
  • Purity of Raw Materials: The purity of each raw material is crucial for the final product.
  • Volume of Water and Organic Solvent: These affect the precipitation and drying processes.
  • Reaction Temperature and Drying Temperature: These parameters influence the stability and solubility of the final product[4].

Claims Analysis

Claim Construction

The claims are constructed to cover both the method of preparation and the resulting composition. This ensures broad protection for the inventors' work.

Dependency Between Claims

The claims are interdependent, with later claims often building on the earlier ones. For example, Claim 3 (use of the chelate composition) depends on Claim 1 (method of preparation) and Claim 2 (composition)[4].

Patent Landscape

Related Patents and Applications

To understand the broader patent landscape, one must search for related patents and applications. Tools like the USPTO's Patent Public Search, Global Dossier, and international patent databases such as those provided by the European Patent Office (EPO) and the World Intellectual Property Organization (WIPO) are essential for this purpose[1].

Prior Art Cited

The patent cites prior art related to iron chelates and their preparation methods. Analyzing these citations can provide insights into the evolution of the technology and potential areas for further innovation.

Economic and Practical Implications

Market Impact

The invention has significant market implications, particularly in the pharmaceutical and nutritional supplement industries. The highly water-soluble ferric pyrophosphate citrate chelate can be used in a variety of products, from food supplements to medical treatments, enhancing the bioavailability of iron.

Cost and Efficiency

The method described in the patent may offer cost and efficiency advantages over existing methods. The use of specific ratios and conditions can lead to higher yields and better product stability, reducing production costs and improving product quality[4].

Legal Considerations

Patent Validity and Enforcement

The validity and enforceability of the patent depend on various legal considerations, including the novelty, non-obviousness, and utility of the invention. The patent must also comply with all legal requirements and regulations set by the USPTO and other relevant authorities.

Litigation and Disputes

In the event of disputes or litigation, the patent's claims and scope will be scrutinized. The clarity and specificity of the claims, as well as the documentation of the invention process, are crucial for defending the patent[5].

Conclusion

United States Patent 7,816,404 represents a significant advancement in the preparation and use of ferric pyrophosphate citrate chelate compositions. The detailed analysis of its scope and claims highlights the importance of this patent in the pharmaceutical and nutritional supplement industries.

Key Takeaways

  • Highly Water-Soluble Composition: The patent describes a method for preparing a highly water-soluble ferric pyrophosphate citrate chelate.
  • Specific Preparation Conditions: The method involves specific ratios of reactants, volumes of water and organic solvents, and controlled temperatures.
  • Broad Applications: The chelate composition can be used as a food supplement, dietary supplement, nutritive supplement, or medical food.
  • Market Impact: The invention has significant implications for the pharmaceutical and nutritional supplement markets.
  • Legal Considerations: The patent's validity and enforceability depend on legal considerations such as novelty, non-obviousness, and utility.

FAQs

Q: What is the main innovation of United States Patent 7,816,404?

A: The main innovation is the method for preparing a highly water-soluble ferric pyrophosphate citrate chelate composition.

Q: What are the key parameters for preparing the chelate composition?

A: The key parameters include the ratio of iron to citrate to pyrophosphate, purity of raw materials, volume of water and organic solvent, reaction temperature, and drying temperature.

Q: How can the chelate composition be used?

A: The composition can be used as a food supplement, dietary supplement, nutritive supplement, or medical food, and can be administered orally or by injection.

Q: Why is the water solubility of the chelate composition important?

A: High water solubility enhances the bioavailability of iron, making the composition more effective for treating iron deficiency.

Q: Where can I find more information about related patents and applications?

A: You can use tools like the USPTO's Patent Public Search, Global Dossier, and international patent databases such as those provided by the EPO and WIPO.

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Drugs Protected by US Patent 7,816,404

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Rockwell Medical Inc TRIFERIC ferric pyrophosphate citrate POWDER;INTRAVENOUS 208551-001 Apr 25, 2016 DISCN Yes No ⤷  Subscribe ⤷  Subscribe METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT ⤷  Subscribe
Rockwell Medical Inc TRIFERIC ferric pyrophosphate citrate SOLUTION;INTRAVENOUS 206317-001 Jan 23, 2015 DISCN Yes No ⤷  Subscribe ⤷  Subscribe Y METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT ⤷  Subscribe
Rockwell Medical Inc TRIFERIC AVNU ferric pyrophosphate citrate SOLUTION;INTRAVENOUS 212860-001 Mar 27, 2020 DISCN Yes No ⤷  Subscribe ⤷  Subscribe Y METHOD OF IRON ADMINISTRATION TO TREAT PATIENTS IN NEED OF IRON REPLACEMENT THERAPY ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 7,816,404

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria E554754 ⤷  Subscribe
Canada 2638081 ⤷  Subscribe
Cyprus 1113903 ⤷  Subscribe
Denmark 2016940 ⤷  Subscribe
European Patent Office 2016940 ⤷  Subscribe
Spain 2383713 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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