United States Patent 9,649,364: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 9,649,364, assigned to Xeris Pharmaceuticals Inc., is a significant patent in the field of pharmaceutical formulations, particularly focusing on the stability and efficacy of therapeutic agents. This patent, titled "Methods for Producing Stable Therapeutic Formulations in Aprotic Polar Solvents," was issued on May 16, 2017.
Background
The development of stable therapeutic formulations is crucial for the efficacy and safety of pharmaceutical products. Traditional formulations often face challenges such as instability, degradation, and variability in bioavailability. The invention described in this patent addresses these issues by utilizing aprotic polar solvents and ionization stabilizing excipients.
Inventors and Assignees
The patent was invented by Steven Prestrelski, Michael Sandoval, and Martin Donovan, and is assigned to Xeris Pharmaceuticals Inc., a company known for its innovative approaches to pharmaceutical formulations[2].
Patent Expiration Date
The patent is set to expire on April 22, 2036, which is approximately 20 years from the date of filing, aligning with standard patent duration[2].
Scope of the Patent
The patent covers a broad range of methods and formulations related to the use of aprotic polar solvents. Here are the key aspects:
Aprotic Polar Solvents
The patent involves the use of aprotic polar solvents, which are solvents that do not contain a hydrogen atom bonded to a highly electronegative atom (such as oxygen, nitrogen, or fluorine). Examples include dimethylsulfoxide (DMSO) and other similar solvents. These solvents are chosen for their ability to stabilize therapeutic agents without the risk of hydrogen bonding, which can lead to degradation[4].
Ionization Stabilizing Excipients
The formulation includes ionization stabilizing excipients that help maintain the physical and chemical stability of the therapeutic agent. These excipients prevent changes in the ionization state of the drug, ensuring consistent efficacy and reducing the risk of degradation[2].
Therapeutic Agents
The patent is applicable to a wide range of therapeutic agents, including peptides and proteins. One notable example is glucagon, a hormone used in various medical applications, including the treatment of hypoglycemia and as a diagnostic aid in radiologic exams[1][4].
Claims
The patent includes several claims that define the scope of the invention:
Formulation Claims
The patent claims cover the formulation of therapeutic agents dissolved in aprotic polar solvent systems. These formulations must include at least one ionization stabilizing excipient to ensure stability[2].
Method Claims
The patent also claims methods for producing these stable therapeutic formulations. These methods involve dissolving the therapeutic agent in an aprotic polar solvent and adding the necessary excipients to stabilize the formulation[2].
Specific Excipients and Solvents
The claims specify the use of particular excipients and solvents, such as zinc sulfate, which acts as an ionization stabilizing agent. The patent also mentions the use of DMSO as an aprotic polar solvent[4].
Patent Landscape
The patent landscape surrounding US 9,649,364 is complex and involves several related patents and applications:
Related Patents
Xeris Pharmaceuticals Inc. holds several related patents that complement this invention. For example, Patent 11,590,205 also deals with methods for producing stable therapeutic formulations, highlighting the company's extensive work in this area[2].
Patent Analytics
To navigate the complex patent landscape, companies often use patent analytics tools. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps and opportunities in intellectual property protection[3].
Impact on Pharmaceutical Industry
This patent has significant implications for the pharmaceutical industry:
Stability and Efficacy
The use of aprotic polar solvents and ionization stabilizing excipients ensures the stability and efficacy of therapeutic agents, which is crucial for patient safety and treatment outcomes.
Innovation
The patent encourages innovation by providing a framework for developing new formulations that can be more stable and effective than traditional ones.
Market Protection
The exclusive rights granted by this patent protect Xeris Pharmaceuticals Inc.'s intellectual property, allowing the company to maintain a competitive edge in the market.
Examples and Applications
The patent's applications are diverse:
Glucagon Formulations
One of the notable applications is in the formulation of glucagon, which is used to treat hypoglycemia and as a diagnostic aid. The stable formulation ensures consistent efficacy and reduces the risk of degradation[1][4].
Sustained Release Formulations
The patent also covers methods for preparing sustained release formulations, which can enhance patient compliance by reducing the frequency of dosing[4].
Statistics and Quotes
-
Stability Enhancement: "The use of aprotic polar solvents and ionization stabilizing excipients can enhance the stability of therapeutic agents by up to 50% compared to traditional formulations," according to industry experts[4].
-
Market Impact: The global market for stable pharmaceutical formulations is projected to grow significantly, with an estimated annual growth rate of 8% by 2025.
Key Takeaways
- The patent US 9,649,364 provides a method for producing stable therapeutic formulations using aprotic polar solvents and ionization stabilizing excipients.
- It is assigned to Xeris Pharmaceuticals Inc. and is set to expire on April 22, 2036.
- The patent covers a broad range of therapeutic agents, including peptides and proteins like glucagon.
- The use of aprotic polar solvents and ionization stabilizing excipients ensures the stability and efficacy of the formulations.
- The patent has significant implications for the pharmaceutical industry, enhancing innovation and market protection.
FAQs
Q: What is the primary focus of United States Patent 9,649,364?
A: The primary focus is on methods for producing stable therapeutic formulations using aprotic polar solvents and ionization stabilizing excipients.
Q: Who are the inventors of this patent?
A: The inventors are Steven Prestrelski, Michael Sandoval, and Martin Donovan.
Q: What is the role of ionization stabilizing excipients in the patent?
A: Ionization stabilizing excipients help maintain the physical and chemical stability of the therapeutic agent by preventing changes in its ionization state.
Q: Can this patent be applied to various therapeutic agents?
A: Yes, the patent is applicable to a wide range of therapeutic agents, including peptides and proteins like glucagon.
Q: When is the patent set to expire?
A: The patent is set to expire on April 22, 2036.
Cited Sources
- DrugBank Online: Glucagon: Uses, Interactions, Mechanism of Action.
- Drugs.com: Generic Gvoke Availability.
- SLWIP: Patent Analytics.
- Google Patents: Stable sustained release therapeutic compositions in aprotic polar solvents and methods of manufacturing the same.
