Detailed Analysis of the Scope and Claims of United States Patent 9,802,973
Introduction
United States Patent 9,802,973, titled "Crystalline forms of ferric maltol," is a significant patent in the pharmaceutical industry, particularly in the treatment of iron deficiency and iron-deficiency anemia. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
Ferric maltol, the active ingredient in the patented composition, is used to treat iron deficiency and iron-deficiency anemia. The patent, issued on October 31, 2017, to SHIELD TX (UK) LTD, covers various crystalline forms of ferric maltol, which are crucial for its pharmaceutical applications[2][4].
Scope of the Patent
The patent focuses on the crystalline forms of ferric maltol, which are essential for the stability, efficacy, and manufacturability of the drug. Here are the key aspects of the patent's scope:
Crystalline Forms
The patent describes four distinct crystalline forms of ferric maltol, denoted as Form I, Form II, Form III, and Form IV. These forms are characterized by their unique powder X-ray diffraction (PXRD) patterns, which are critical for identifying and distinguishing between these polymorphic forms[4].
Pharmaceutical Composition
The patent includes claims for pharmaceutical compositions that contain these crystalline forms of ferric maltol, along with pharmaceutically acceptable excipients. These compositions are designed to enhance the bioavailability and stability of the drug[4].
Manufacturing Process
The patent details various methods for preparing these crystalline forms. This includes processes such as dissolving ferric maltol in solvents, evaporating the solvent, and isolating the desired crystalline form. The specific conditions, such as temperature and pH adjustments, are also outlined to ensure the production of high-purity crystalline forms[4].
Claims of the Patent
The patent contains several claims that define the scope of the invention:
Claim 1: Crystalline Forms
The patent claims four distinct crystalline forms of ferric maltol, each characterized by specific PXRD patterns. For example, Form I is characterized by peaks at specific degrees (e.g., 9.4, 12.7, 14.4, 15.2, 17.3, 19.8, 21.1, 23, 24.3° 2Θ±0.2° 2Θ)[4].
Claim 2: Pharmaceutical Composition
The patent claims pharmaceutical compositions that include these crystalline forms of ferric maltol along with one or more pharmaceutically acceptable excipients. These compositions are tailored for oral administration, such as in capsule form[2][4].
Claim 3: Manufacturing Process
The patent claims the processes for preparing these crystalline forms, including the steps of dissolving ferric maltol in a solvent, evaporating the solvent, and isolating the crystalline form. Specific conditions and reagents used in these processes are also claimed[4].
Patent Landscape
The patent landscape surrounding US 9,802,973 is complex and involves several related patents and exclusivities:
Related Patents
- Dosage Regimen of Ferric Trimaltol: Patent 10,179,120 covers a dosage regimen for ferric trimaltol, another iron hydroxypyrone compound, for treating iron deficiency with or without anemia[2].
- H. pylori Treatment: Patent 9,248,148 involves compositions that include iron hydroxypyrone compounds for treating inflammatory diseases of the gastrointestinal tract and increasing iron levels in patients[2].
Exclusivity and Generic Availability
As of the current date, there is no therapeutically equivalent generic version of Accrufer (ferric maltol) available in the United States. The patent and exclusivity periods protect the proprietary rights of the manufacturer, SHIELD TX, until the patent expiration dates, which are set for March 29, 2031[2][5].
Patent Expiration Dates
The patent is set to expire on March 29, 2031, after which generic versions could potentially be developed and approved. However, any generic version must demonstrate bioequivalence to the Reference Listed Drug (RLD), which is Accrufer in this case[2][5].
Impact on Pharmaceutical Industry
The patent has significant implications for the pharmaceutical industry:
Stability and Efficacy
The crystalline forms of ferric maltol ensure better stability and efficacy of the drug, which is crucial for treating iron deficiency and iron-deficiency anemia. This enhances patient outcomes and compliance.
Manufacturing Efficiency
The detailed manufacturing processes outlined in the patent help in streamlining the production of ferric maltol, reducing costs and improving quality control.
Market Protection
The patent and exclusivity periods provide market protection, allowing the manufacturer to recoup investment in research and development without immediate generic competition.
Key Takeaways
- Crystalline Forms: The patent covers four distinct crystalline forms of ferric maltol, each with unique PXRD patterns.
- Pharmaceutical Composition: The patent includes claims for pharmaceutical compositions containing these crystalline forms along with pharmaceutically acceptable excipients.
- Manufacturing Process: Detailed processes for preparing these crystalline forms are outlined.
- Patent Landscape: The patent is part of a broader landscape that includes related patents and exclusivities protecting the manufacturer's rights.
- Impact: The patent enhances the stability, efficacy, and manufacturability of ferric maltol, with significant implications for patient care and market dynamics.
FAQs
Q: What is the main subject of United States Patent 9,802,973?
A: The main subject is the crystalline forms of ferric maltol, a drug used to treat iron deficiency and iron-deficiency anemia.
Q: How many crystalline forms of ferric maltol are described in the patent?
A: The patent describes four distinct crystalline forms of ferric maltol, denoted as Form I, Form II, Form III, and Form IV.
Q: What is the significance of the PXRD patterns in the patent?
A: The PXRD patterns are used to characterize and distinguish between the different crystalline forms of ferric maltol.
Q: Is there a generic version of Accrufer (ferric maltol) available?
A: No, there is currently no therapeutically equivalent generic version of Accrufer available in the United States.
Q: When is the patent set to expire?
A: The patent is set to expire on March 29, 2031.
Sources
- US9802973B2 - Crystalline forms of ferric maltol - Google Patents
- Generic Accrufer Availability - Drugs.com
- Patent Claims and Patent Scope - SSRN
- Novel polymorphic form of ferric maltol - Justia Patents
- Accrufer patent expiration - Pharsight
