United States Patent 6,733,783: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 6,733,783, titled "Controlled release hydrocodone formulations," is a significant patent in the pharmaceutical industry, particularly in the realm of pain management. This patent, held by Purdue Pharma, among others, pertains to specific formulations of hydrocodone designed to provide a controlled release of the active ingredient over an extended period.
Background
Hydrocodone is a widely used opioid for managing moderate to severe pain. The development of controlled-release formulations aims to improve patient compliance and reduce the risk of abuse by providing a steady and sustained release of the medication.
Patent Overview
Publication and Status
The patent was granted on May 11, 2004, and has since expired due to the natural lifespan of patents, which typically last for 20 years from the date of filing[1].
Inventors and Assignees
The patent was assigned to Purdue Pharma, among other entities, reflecting the collaborative efforts in pharmaceutical research and development.
Scope of the Patent
Controlled Release Formulations
The patent describes hydrocodone formulations that exhibit a therapeutic effect for at least about 24 hours or more when administered to a human. This controlled release is achieved through various formulation techniques, including the use of specific excipients and coating technologies[1].
Dosage Forms
The patent covers various dosage forms such as tablets, capsules, and other solid oral dosage forms. These formulations are designed to release hydrocodone in a controlled manner, ensuring a consistent therapeutic effect over an extended period.
Therapeutic Benefits
The controlled release formulations offer several therapeutic benefits, including reduced dosing frequency, improved patient compliance, and potentially lower peak-to-trough fluctuations in plasma drug concentrations, which can help in managing pain more effectively.
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically describe the composition of the formulation, the method of preparation, and the characteristics of the controlled release profile[1].
Dependent Claims
Dependent claims further specify the details of the independent claims, such as the types of excipients used, the coating materials, and the specific release profiles.
Patent Landscape
Related Patents
The patent landscape surrounding US 6,733,783 includes several related patents that cover various aspects of controlled-release hydrocodone formulations. For example, patents like US 8,361,499, US 8,551,520, and others listed in the Orange Book, are associated with Purdue Pharma’s Hysingla® ER product, which is another controlled-release hydrocodone formulation[2][5].
Litigation and Infringement
The patent has been involved in several litigation cases, particularly regarding patent infringement claims against generic manufacturers. These cases highlight the importance of this patent in protecting the intellectual property rights of the original developers[2][5].
Technical Aspects
Formulation Techniques
The patent details various formulation techniques, including the use of hydrophilic and hydrophobic excipients, and different coating technologies to achieve the desired controlled release profile. These techniques are crucial in ensuring the stability and efficacy of the formulation[1].
Pharmacokinetics
The controlled release formulations are designed to provide a specific pharmacokinetic profile, ensuring that the hydrocodone is released in a manner that maintains therapeutic levels over an extended period. This is critical for effective pain management and minimizing side effects.
Market Impact
Hysingla® ER
The patent is closely associated with Hysingla® ER, a product of Purdue Pharma, which is listed in the FDA's Orange Book. This product has significant market presence and is protected by a series of patents, including US 6,733,783, which helps in maintaining its market exclusivity[2].
Generic Challenges
Generic manufacturers have challenged the validity of these patents through Abbreviated New Drug Applications (ANDAs) and Paragraph IV notices, leading to extensive litigation. These challenges reflect the commercial importance of controlled-release hydrocodone formulations in the pharmaceutical market[2][5].
Regulatory Considerations
FDA Approval
The New Drug Application (NDA) for Hysingla® ER, which is covered by this patent, was approved by the FDA for various dosage strengths. The FDA's approval process includes a thorough review of the formulation's safety, efficacy, and manufacturing process[2].
Patent Listings
The patents associated with Hysingla® ER, including US 6,733,783, are listed in the FDA's Orange Book, which is a critical resource for understanding the patent landscape of approved drugs[2].
Conclusion
The United States Patent 6,733,783 is a pivotal patent in the development of controlled-release hydrocodone formulations. It covers a range of formulation techniques and dosage forms designed to provide sustained therapeutic effects. The patent's involvement in litigation and its association with Hysingla® ER highlight its significance in the pharmaceutical industry.
Key Takeaways
- Controlled Release Formulations: The patent describes formulations that release hydrocodone over at least 24 hours.
- Dosage Forms: Includes tablets, capsules, and other solid oral dosage forms.
- Therapeutic Benefits: Reduces dosing frequency, improves compliance, and minimizes peak-to-trough fluctuations.
- Patent Landscape: Part of a broader landscape including related patents and litigation.
- Market Impact: Associated with Hysingla® ER, a significant product in pain management.
- Regulatory Considerations: Approved by FDA and listed in the Orange Book.
FAQs
Q: What is the primary focus of the United States Patent 6,733,783?
A: The primary focus is on controlled-release hydrocodone formulations designed to provide a therapeutic effect for at least 24 hours.
Q: Which product is closely associated with this patent?
A: The product is Hysingla® ER, a controlled-release hydrocodone formulation developed by Purdue Pharma.
Q: Why is this patent significant in the pharmaceutical industry?
A: It is significant due to its impact on pain management, patient compliance, and the protection of intellectual property rights.
Q: What are the key formulation techniques described in the patent?
A: The techniques include the use of hydrophilic and hydrophobic excipients and different coating technologies.
Q: Has this patent been involved in any litigation?
A: Yes, it has been involved in several litigation cases related to patent infringement claims against generic manufacturers.
Sources
- US6733783B2 - Controlled release hydrocodone formulations - Google Patents
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... - Insight.RPXcorp
- Patent Claims Research Dataset - USPTO
- Research and Course Guides: Patent Searching, Advanced: Overview - Clemson University
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... - Insight.RPXcorp
