United States Patent 7,988,998: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,988,998, titled "Sustained-release tramadol formulations with 24-hour efficacy," is a significant patent in the pharmaceutical field, particularly in the development of pain management medications. This patent, granted to the inventors, outlines a novel formulation of tramadol that provides a sustained release of the drug over a 24-hour period.
Background of Tramadol
Tramadol is a synthetic opioid analgesic used to treat moderate to moderately severe pain. It works by binding to opioid receptors in the brain and also inhibiting the reuptake of norepinephrine and serotonin, which are neurotransmitters involved in pain regulation[4].
Scope of the Patent
The patent focuses on the development of a sustained-release formulation of tramadol, designed to provide an analgesic effect within a 24-hour period following a single dose. This formulation is crucial for improving patient compliance and reducing the need for frequent dosing.
Key Components of the Formulation
- Active Pharmaceutical Agent: The formulation primarily contains tramadol as the active pharmaceutical agent.
- Controlled Release Mechanism: The patent describes a controlled release mechanism that ensures the gradual release of tramadol over 24 hours. This is achieved through the use of specific polymers and matrix materials such as polyvinyl acetate, polyvinylpyrrolidone, and amylomaize[1][4].
- Excipients and Additives: The formulation may include various excipients like magnesium stearate, hydrogenated vegetable oil, and binding agents to enhance the stability and release profile of the drug.
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Composition Claims
- The patent claims a pharmaceutical composition comprising tramadol and a controlled release matrix material that ensures the sustained release of tramadol over 24 hours[1][4].
- Specific claims include the use of polyvinyl acetate and polyvinylpyrrolidone as key components of the matrix material.
Method Claims
- The patent claims methods for preparing the sustained-release formulation, including the process of mixing the active ingredient with the matrix material and other excipients, followed by compression into a tablet form[1][4].
Effect Claims
- The patent claims that the formulation provides an analgesic effect within 24 hours of administration, maintaining therapeutic plasma concentrations of tramadol over this period[1][4].
Patent Landscape
International Patents
The concept of sustained-release tramadol formulations is not limited to the US patent. Similar patents have been filed and granted in other jurisdictions, such as the European Patent Office (EPO), under the patent number EP1594460B1. These international patents reflect the global interest in developing and commercializing sustained-release tramadol formulations[4].
Expiration and Generic Entry
The US Patent 7,988,998 has a specific expiration date, after which generic versions of the sustained-release tramadol formulation can be developed and marketed. This expiration date is crucial for pharmaceutical companies planning to enter the market with generic alternatives[2].
Litigation and Patent Value
Patent litigation is a significant aspect of the pharmaceutical industry, and patents like US 7,988,998 can be involved in such disputes. The value of a patent is often determined by its citation frequency and the number of times it has been referenced in other patents. High-value patents, especially those with a history of litigation, can command substantial damages in infringement cases[3].
Impact on Pharmaceutical Industry
Patient Compliance
The sustained-release formulation of tramadol enhances patient compliance by reducing the frequency of dosing, which is a common issue with immediate-release formulations.
Market Competition
The expiration of this patent opens up the market for generic versions, increasing competition and potentially reducing the cost of the medication for consumers.
Research and Development
The development of sustained-release formulations like the one described in this patent drives innovation in the pharmaceutical industry. It encourages further research into controlled release technologies and the application of these technologies to other medications.
Core Patent Analysis
Citation Frequency
The number of times a patent is cited by other patents is an indicator of its importance and value. Patents like US 7,988,998, which have been frequently cited, are considered core patents and hold significant value in the pharmaceutical landscape[3].
Technical Concepts
The core patent analysis reveals that the technical concepts in this field focus on pharmaceutical compositions, effective amounts, and controlled release mechanisms. The University of California, among other top universities, has been at the forefront of such research, contributing significantly to the development of new pharmaceutical technologies[3].
Conclusion
The United States Patent 7,988,998 represents a significant advancement in the field of pain management through the development of a sustained-release tramadol formulation. This patent's scope, claims, and impact on the pharmaceutical landscape highlight its importance in improving patient care and driving innovation.
Key Takeaways
- Sustained Release: The patent describes a formulation that provides a 24-hour analgesic effect from a single dose.
- Controlled Release Mechanism: The use of specific polymers and matrix materials ensures the gradual release of tramadol.
- Global Relevance: Similar patents exist in other jurisdictions, reflecting global interest in this technology.
- Patient Compliance: The formulation enhances patient compliance by reducing dosing frequency.
- Market Impact: The expiration of this patent will increase market competition and potentially reduce medication costs.
FAQs
What is the primary benefit of the sustained-release tramadol formulation described in US Patent 7,988,998?
The primary benefit is the provision of a 24-hour analgesic effect from a single dose, enhancing patient compliance and reducing the need for frequent dosing.
What are the key components of the sustained-release formulation?
The key components include tramadol as the active pharmaceutical agent, and polymers such as polyvinyl acetate and polyvinylpyrrolidone as part of the controlled release matrix material.
How does the patent impact the pharmaceutical industry?
The patent drives innovation in controlled release technologies, enhances patient compliance, and upon expiration, opens the market for generic versions, increasing competition and potentially reducing costs.
What is the significance of patent citations in evaluating patent value?
Patent citations indicate the importance and value of a patent. Frequently cited patents, like US 7,988,998, are considered core patents and hold significant value in the pharmaceutical landscape.
Which institutions are leading in pharmaceutical patent research and development?
Universities such as the University of California, Johns Hopkins University, and the University of Texas System are among the top institutions in pharmaceutical patent research and development, contributing significantly to new pharmaceutical technologies[3].
Sources
- Google Patents: US7988998B2 - Sustained-release tramadol formulations with 24-hour efficacy.
- Drug Patent Watch: Patent 7988998.
- SCIRP: Analysis of Drug Patent in American Universities Based on Xlpat.
- Google Patents: EP1594460B1 - Sustained-release tramadol formulations with 24-hour efficacy.
