United States Patent 9,555,005: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,555,005, titled "Extended-release topiramate capsules," is a significant patent in the pharmaceutical industry, particularly in the field of epilepsy and other neurological disorders. This patent, granted to an undisclosed assignee, outlines a specific formulation and method for delivering topiramate, a medication commonly used to treat epilepsy, migraines, and other conditions.
Background of Topiramate
Topiramate is an anticonvulsant drug that has been widely used since its approval by the FDA in 1996. It is known for its efficacy in treating various types of seizures and migraines. However, its immediate-release formulation can have drawbacks such as frequent dosing and potential side effects due to peak plasma concentrations.
Scope of the Patent
The patent US 9,555,005 focuses on an extended-release formulation of topiramate capsules, designed to improve the therapeutic profile of the drug by providing a more stable and sustained release of the active ingredient.
Key Components
- Capsule Shell: The patent describes a capsule shell containing a single population of coated particles. Each particle is designed to release topiramate in a controlled manner over an extended period[1].
- Coated Particles: The coated particles are formulated with various excipients such as starch, carboxymethyl cellulose, microcrystalline cellulose, polyethylene glycol, and methylcellulose. These excipients help in achieving the desired release profile[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 describes the extended-release topiramate capsule comprising a capsule shell containing a single population of coated particles, where each coated particle includes a core containing topiramate and a coating layer[1].
- Claim 2 specifies the composition of the coating layer, which includes a combination of polymers and other excipients to achieve the extended-release profile[1].
Dependent Claims
- Subsequent claims detail various aspects of the formulation, including the ratio of topiramate to excipients, the thickness of the coating layer, and the method of manufacturing the coated particles[1].
Patent Landscape
The patent landscape surrounding US 9,555,005 is complex and involves several key aspects:
Competing Formulations
Other pharmaceutical companies have developed their own extended-release formulations of topiramate. These formulations may differ in their composition, manufacturing process, or release profiles, but they aim to achieve similar therapeutic benefits[5].
Litigation and Settlements
Patent litigation is common in the pharmaceutical industry, especially when generic versions of drugs are introduced. Settlements and litigation outcomes, such as those seen in ANDA (Abbreviated New Drug Application) cases, can significantly impact the market availability of generic versions of extended-release topiramate capsules[2].
Regulatory Environment
The FDA plays a crucial role in approving new drug formulations, including extended-release versions of existing medications. The regulatory environment can influence the patent landscape by affecting the approval process and the timing of generic entries into the market[4].
Technological and Scientific Aspects
The technological and scientific aspects of this patent are centered around the formulation and manufacturing process:
Excipients and Coating
The use of specific excipients and the design of the coating layer are critical in achieving the desired extended-release profile. The patent details the role of each excipient and how they interact to control the release of topiramate[1].
Manufacturing Process
The manufacturing process involves coating the topiramate core with a layer that ensures a consistent and controlled release. This process is crucial for maintaining the efficacy and safety of the drug[1].
Market Impact
The extended-release topiramate capsules have a significant market impact:
Patient Compliance
An extended-release formulation can improve patient compliance by reducing the frequency of dosing, which can lead to better therapeutic outcomes and reduced side effects[1].
Competitive Advantage
For the patent holder, this formulation provides a competitive advantage in the market by offering a differentiated product that can attract patients and healthcare providers looking for more convenient and effective treatment options.
Future Developments
The future of this patent and similar formulations will be influenced by several factors:
Generic Entries
As the patent nears its expiration, generic versions of the extended-release topiramate capsules may enter the market, potentially reducing the market share of the branded product[2].
New Formulations
Continued research and development may lead to new formulations with improved release profiles or additional therapeutic benefits, further evolving the treatment landscape for epilepsy and other conditions.
Key Takeaways
- Extended-Release Formulation: The patent US 9,555,005 describes an extended-release formulation of topiramate capsules designed to improve patient compliance and therapeutic outcomes.
- Complex Patent Landscape: The patent landscape involves competing formulations, litigation, and regulatory considerations.
- Technological Significance: The use of specific excipients and a controlled coating process is crucial for achieving the desired release profile.
- Market Impact: The formulation can improve patient compliance and provide a competitive advantage in the market.
FAQs
What is the main benefit of the extended-release topiramate capsules described in US 9,555,005?
The main benefit is the improved patient compliance and reduced side effects due to a more stable and sustained release of topiramate.
What are the key components of the extended-release topiramate capsules?
The key components include a capsule shell containing coated particles, with each particle having a core of topiramate and a coating layer made of various excipients.
How does the patent landscape affect the availability of generic versions of extended-release topiramate capsules?
The patent landscape, including litigation and settlements, can delay or prevent the entry of generic versions into the market, affecting their availability.
What role do excipients play in the extended-release formulation?
Excipients such as starch, carboxymethyl cellulose, and polyethylene glycol are crucial in controlling the release profile of topiramate from the coated particles.
How does the FDA influence the approval of new drug formulations like the one described in US 9,555,005?
The FDA plays a critical role in approving new drug formulations, ensuring they meet safety and efficacy standards, which can impact the timing and availability of these formulations in the market.
Cited Sources
- US9555005B2 - Extended-release topiramate capsules - Google Patents
- ANDA Litigation Settlements | Hatch-Waxman | Robins Kaplan LLP
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- Extended-release topiramate capsules - Patent US-2014271839-A1 - PubChem
