United States Patent 11,986,449: A Detailed Analysis
Overview of the Patent
United States Patent 11,986,449, titled "Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof," is a significant patent in the field of pharmaceuticals, particularly for the treatment of Parkinson's disease. Here is a detailed analysis of its scope, claims, and the broader patent landscape.
Patent Assignee and Inventors
The patent is assigned to Impax Laboratories, LLC, and the inventors include Hsu Ann, Dong Liang C., Ding Amy, and Gupta Suneel[1].
Patent Expiration Date
The patent is set to expire on December 21, 2041, which is one of the later expiration dates among the related patents in this series[1].
Scope of the Patent
Controlled Release Formulation
The patent describes a controlled release oral solid formulation designed to improve the delivery of levodopa, a crucial medication for treating Parkinson's disease. The formulation consists of:
- Controlled Release Component: This includes a core comprising levodopa and/or an ester of levodopa or its salts. The core is coated with a layer of a muco-adhesive polymer and externally coated with a layer of an enteric coated polymer.
- Decarboxylase Inhibitor Component: This component is included to prevent the premature conversion of levodopa to dopamine outside the brain, thereby enhancing the efficacy of the medication[1].
Muco-Adhesive and Enteric Coatings
The muco-adhesive polymer coating ensures that the formulation adheres to the mucosal surfaces in the gastrointestinal tract, prolonging the release of levodopa. The enteric coating protects the formulation from the acidic environment of the stomach, ensuring that the medication is released in the intestines where it can be more effectively absorbed[1].
Claims of the Patent
The patent claims are comprehensive and cover various aspects of the formulation:
- Composition Claims: These claims specify the exact composition of the controlled release component, including the types of polymers used for the muco-adhesive and enteric coatings.
- Method of Manufacture Claims: These claims detail the process of manufacturing the formulation, including the steps involved in coating the core with the muco-adhesive and enteric polymers.
- Use Claims: These claims outline the therapeutic uses of the formulation, specifically for the treatment of Parkinson's disease[1].
Patent Landscape
Related Patents
Several related patents have been issued with similar claims and expiration dates, indicating a robust patent strategy by Impax Laboratories, LLC. These patents include:
- Patent 10,098,845: Issued on October 16, 2018, with an expiration date of October 7, 2034.
- Patent 10,292,935: Issued on May 21, 2019, with an expiration date of October 7, 2034.
- Patent 10,688,058: Issued on June 23, 2020, with an expiration date of October 7, 2034.
- Patent 11,357,733: Issued on June 14, 2022, with an expiration date of October 7, 2034[1].
These patents collectively protect various aspects of the muco-adhesive, controlled release formulations of levodopa and its esters, ensuring a strong intellectual property position for Impax Laboratories, LLC.
Competitive Landscape
The patent landscape in the field of Parkinson's disease treatments is highly competitive, with multiple pharmaceutical companies developing innovative formulations to improve patient outcomes. The unique combination of muco-adhesive and enteric coatings in this patent sets it apart from other formulations, providing a competitive edge in terms of drug delivery and efficacy.
International Patent Protection
While the analysis focuses on the U.S. patent, it is crucial to note that similar patents may be filed in other jurisdictions to secure global intellectual property protection. Tools like the Global Dossier and international patent databases (such as those provided by the European Patent Office, Japan Patent Office, and World Intellectual Property Organization) can help in tracking related patents worldwide[3].
Impact on Treatment of Parkinson's Disease
Enhanced Drug Delivery
The controlled release formulation described in the patent offers several advantages in the treatment of Parkinson's disease:
- Improved Bioavailability: The muco-adhesive coating ensures that the medication is released over a longer period, enhancing bioavailability and reducing the need for frequent dosing.
- Stable Plasma Levels: The enteric coating protects the medication from gastric acid, leading to more stable plasma levels of levodopa and its active metabolites.
- Better Patient Compliance: The once-daily dosing regimen made possible by this formulation can improve patient compliance, which is critical for managing a chronic condition like Parkinson's disease[1].
Clinical Significance
The clinical significance of this patent lies in its potential to improve the quality of life for patients with Parkinson's disease. By providing a more stable and consistent delivery of levodopa, this formulation can help in managing symptoms more effectively and reducing the side effects associated with traditional immediate-release formulations.
Key Takeaways
- Innovative Formulation: The patent describes a unique muco-adhesive and enteric-coated formulation for controlled release of levodopa.
- Strong Intellectual Property Position: The patent is part of a series of related patents that collectively protect the formulation and its manufacturing process.
- Improved Treatment Outcomes: The formulation has the potential to enhance drug delivery, improve bioavailability, and increase patient compliance.
- Competitive Edge: The unique combination of coatings sets this formulation apart in a competitive market.
FAQs
What is the main innovation of United States Patent 11,986,449?
The main innovation is the development of a controlled release oral solid formulation of levodopa with a muco-adhesive and enteric coating.
Who are the inventors of this patent?
The inventors include Hsu Ann, Dong Liang C., Ding Amy, and Gupta Suneel.
What is the expiration date of this patent?
The patent is set to expire on December 21, 2041.
How does the muco-adhesive coating benefit the formulation?
The muco-adhesive coating ensures that the formulation adheres to the mucosal surfaces in the gastrointestinal tract, prolonging the release of levodopa.
What is the clinical significance of this patent?
The patent has the potential to improve the quality of life for patients with Parkinson's disease by providing a more stable and consistent delivery of levodopa.
Are there related patents protecting similar formulations?
Yes, there are several related patents with similar claims and expiration dates, collectively protecting various aspects of the formulation.
Sources
- Generic Crexont Availability - Drugs.com
- U.S. Patent and Trademark Office (USPTO) - USA.gov
- Search for patents | USPTO - USPTO
- US11918623B2 - GIP/GLP1 agonist compositions - Google Patents
- Drugs Protected by US Patent 11986449 - DrugPatentWatch
