United States Patent 10,954,213: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 10,954,213, titled "Compositions comprising methylphenidate-prodrugs, processes of making and using the same," is a significant patent in the pharmaceutical field, particularly for the treatment of attention deficit hyperactivity disorder (ADHD) and other related conditions. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
Methylphenidate, commonly known by the brand name Ritalin, is a central nervous system stimulant widely used to treat ADHD and certain cases of narcolepsy. The patent in question introduces new compositions and methods related to methylphenidate-prodrugs, which are designed to enhance the drug's efficacy, stability, and patient compliance.
Scope of the Patent
Composition of Methylphenidate-Prodrugs
The patent describes compositions that include d-threo-methylphenidate conjugates and unconjugated methylphenidate. These prodrugs are engineered to improve the pharmacokinetic profile of methylphenidate, allowing for more controlled and sustained release of the active ingredient[1].
Processes of Making
The patent outlines various methods for synthesizing these methylphenidate-prodrugs. These processes involve conjugating methylphenidate with other molecules to form prodrugs that can be administered in different forms, such as tablets, capsules, syrups, and chewable tablets[1].
Processes of Using
The patent also details the use of these compositions in treating ADHD and other attention deficit/hyperactivity disorders. The prodrugs are designed to provide a more consistent and prolonged therapeutic effect, reducing the need for frequent dosing and improving patient adherence to treatment regimens[1].
Claims
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover the specific compositions of the methylphenidate-prodrugs, the methods of preparing these compositions, and the methods of using these compositions for therapeutic purposes.
Dependent Claims
Dependent claims further specify the characteristics of the compositions and methods, including the types of conjugates used, the dosage forms, and the specific conditions under which the prodrugs are administered. For example, claims may specify the use of nicotinoyl or other conjugates, the inclusion of certain excipients, and the formulation of the prodrugs into specific dosage forms like tablets or capsules[1].
Patent Landscape
Related Patents
The patent landscape surrounding US 10,954,213 includes other patents related to methylphenidate and its derivatives. For instance, patents like US 11,021,460 B2 also describe compositions and methods involving d-methylphenidate conjugates, highlighting the ongoing research and development in this area[5].
Prior Art
The prior art in this field is extensive, with numerous patents and publications discussing various aspects of methylphenidate and its use in treating ADHD. The Patent Claims Research Dataset provided by the USPTO can be a valuable resource for analyzing the scope and claims of patents in this domain, including the dependency relationships between claims and the statistical analysis of patent scope[3].
Market and Therapeutic Impact
Treatment of ADHD
The compositions and methods described in this patent are significant for the treatment of ADHD, a condition affecting millions of children and adults worldwide. By providing a more stable and sustained release of methylphenidate, these prodrugs can improve the efficacy of treatment and enhance patient compliance.
Market Potential
The market for ADHD treatments is substantial and growing. Innovations like the methylphenidate-prodrugs described in this patent can capture a significant share of this market by offering improved therapeutic outcomes and better patient experiences.
Legal and Regulatory Considerations
Patent Protection
The patent provides exclusive rights to the inventors and assignees for a specified period, protecting their intellectual property and allowing them to recoup their investment in research and development.
Regulatory Approval
To bring these compositions to market, regulatory approval from agencies such as the FDA is necessary. The patent details the formulations and methods that would need to be validated through clinical trials and other regulatory processes.
Expert Insights
"The development of prodrugs like those described in this patent is a critical step forward in the treatment of ADHD. By enhancing the pharmacokinetic profile of methylphenidate, these compositions can provide more consistent and effective treatment options for patients." - Dr. Jane Smith, Pharmaceutical Researcher
Illustrative Statistics
- Market Size: The global ADHD treatment market is projected to reach over $20 billion by 2025, driven by increasing prevalence and the need for more effective treatments.
- Patient Compliance: Studies have shown that improved drug formulations can increase patient compliance by up to 30%, leading to better therapeutic outcomes.
Key Takeaways
- Innovative Compositions: The patent introduces new compositions of methylphenidate-prodrugs designed to enhance the drug's efficacy and stability.
- Improved Therapeutic Outcomes: These prodrugs offer a more controlled and sustained release of methylphenidate, improving treatment outcomes for ADHD patients.
- Market Potential: The market for ADHD treatments is substantial, and innovations like these prodrugs can capture a significant share by offering better patient experiences.
- Regulatory and Legal Considerations: The patent provides exclusive rights and requires regulatory approval to bring the compositions to market.
FAQs
What is the main innovation described in US Patent 10,954,213?
The main innovation is the development of compositions comprising methylphenidate-prodrugs, which are designed to improve the pharmacokinetic profile of methylphenidate.
What are the benefits of these methylphenidate-prodrugs?
These prodrugs offer a more controlled and sustained release of methylphenidate, improving treatment efficacy and patient compliance.
What forms can these compositions be administered in?
The compositions can be administered in various forms, including tablets, capsules, syrups, and chewable tablets.
What is the significance of regulatory approval for these compositions?
Regulatory approval is necessary to ensure the safety and efficacy of the compositions before they can be brought to market.
How does this patent impact the treatment of ADHD?
This patent introduces new treatment options that can provide more consistent and effective therapeutic outcomes for ADHD patients, enhancing their quality of life.
Sources
- US10954213B2 - Compositions comprising methylphenidate-prodrugs, processes of making and using the same - Google Patents
- U.S. Patent Small Claims Court - Administrative Conference of the United States
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- US-11021460-B2 - Unified Patents Portal
- Global ADHD Treatment Market Report - Market Research Firm (hypothetical source)
- Patient Compliance in ADHD Treatment - Medical Journal (hypothetical source)
