United States Patent 8,309,124: A Detailed Analysis
Overview of the Patent
United States Patent 8,309,124, titled "Delayed release tablet with defined core geometry," is a patent that describes a specific formulation and manufacturing process for delayed-release tablets. This patent is particularly relevant in the pharmaceutical industry, especially for drugs that require controlled release profiles.
Patent Description
The patent outlines a method for creating delayed-release tablets using compression coating techniques. These tablets are designed with a defined core geometry, which is crucial for controlling the release of the active substance over a specified period. The core of the tablet contains the active substance, and it is coated with a layer that delays the release of the drug until it reaches the desired part of the gastrointestinal tract[1].
Key Components and Claims
Active Substance and Coating
The patent specifies that the core of the tablet can contain various active substances, such as prednisone, methylprednisolone, and prednisolone, which are commonly used corticosteroids. The coating layer is designed to be hydrophobic and can include materials like polyvinylpyrrolidone, povidone, and colloidal silicon dioxide[1].
Manufacturing Process
The manufacturing process involves compression coating methods, where the core tablet is first formed and then coated with the delayed-release layer. This process ensures that the tablet has a uniform geometry, which is essential for consistent drug release[1].
Dosage Form
The patent describes the dosage form as a delayed-release tablet, which is designed to release the active substance at a specific time after ingestion. This is achieved through the combination of the core geometry and the coating layer[1].
Patent Landscape and Analysis
Technological Context
The patent is part of a broader landscape of pharmaceutical formulations aimed at controlled drug delivery. The technology involves advanced coating methods and specific core geometries to achieve the desired release profiles. This area is highly competitive, with numerous patents and ongoing research focused on improving drug delivery systems[3].
Market and Regulatory Environment
The patent is listed in the FDA's Orange Book, which indicates its significance in protecting the intellectual property of the drug formulation. The Orange Book listing also implies that the patent is relevant to the approval process for generic versions of the drug. For instance, Horizon Pharma Inc. filed a patent infringement lawsuit against Watson Laboratories, Inc., citing this patent among others, to protect their proprietary formulation of RAYOS®[2][5].
Competitors and New Entrants
The patent landscape in this area is dynamic, with several key players and new entrants. Companies like Horizon Pharma Inc. and Watson Laboratories, Inc. are actively involved in developing and protecting their intellectual property in delayed-release formulations. New entrants often face significant barriers due to the existing patent landscape, which can limit their ability to enter the market without infringing on existing patents[3].
Country-Based Trends and Regulations
The patent landscape varies by country, with different regulatory environments and market trends. In the United States, patents like 8,309,124 are subject to strict regulatory oversight by the FDA, particularly when it comes to generic approvals. The patent's expiration date, January 7, 2028, is crucial for understanding the timeline for potential generic entries into the market[2].
Litigation and Enforcement
The patent has been involved in significant litigation, particularly in the context of generic drug approvals. Horizon Pharma Inc. has taken legal action against Watson Laboratories, Inc. for alleged infringement of this patent, among others. The lawsuit highlights the importance of this patent in protecting the proprietary formulation of RAYOS® and the potential financial implications of patent infringement[2][5].
Impact on the Pharmaceutical Industry
This patent has a substantial impact on the pharmaceutical industry, particularly in the development of delayed-release formulations. It sets a standard for the design and manufacturing of such tablets, influencing both the formulation and the regulatory approval process. Companies must navigate this patent landscape carefully to avoid infringement while developing their own delayed-release products.
Key Takeaways
- Delayed Release Technology: The patent describes a method for creating delayed-release tablets with defined core geometry, crucial for controlled drug delivery.
- Manufacturing Process: The process involves compression coating techniques to ensure uniform geometry and consistent drug release.
- Regulatory Significance: Listed in the FDA's Orange Book, the patent is critical for protecting intellectual property and influencing generic drug approvals.
- Litigation: The patent has been involved in significant litigation, highlighting its importance in the pharmaceutical industry.
- Market Impact: The patent affects the development and approval of delayed-release formulations, setting standards for design and manufacturing.
FAQs
What is the main purpose of United States Patent 8,309,124?
The main purpose of this patent is to describe a method for creating delayed-release tablets with defined core geometry, ensuring controlled release of the active substance.
Which drugs are mentioned in the patent as examples of active substances?
The patent mentions prednisone, methylprednisolone, and prednisolone as examples of active substances that can be used in the delayed-release tablets.
What is the significance of the patent being listed in the FDA's Orange Book?
Being listed in the FDA's Orange Book indicates that the patent is relevant to the approval process for generic versions of the drug, providing a layer of protection for the proprietary formulation.
What is the current legal status of the patent?
The patent is set to expire on January 7, 2028, which is crucial for understanding the timeline for potential generic entries into the market.
How does the patent impact the development of new pharmaceutical products?
The patent sets a standard for the design and manufacturing of delayed-release tablets, influencing both the formulation and the regulatory approval process for new products.
Sources
- US8309124B2 - Delayed release tablet with defined core geometry - Google Patents
- Horizon Pharma, Inc. Files Patent Infringement Lawsuit Against Watson Laboratories, Inc. - Biospace
- Patent Landscape Search, Analysis and Report: An Overview - Prometheus IP
- Prednisone: Uses, Interactions, Mechanism of Action - DrugBank
- COMPLAINT NATURE OF THE ACTION THE PARTIES - Insight.RPXcorp.com
