United States Patent 8,114,383: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,114,383, titled "Abuse-proofed dosage form," is a significant patent in the pharmaceutical industry, particularly in the realm of controlled-release medications and abuse-deterrent formulations. This patent, held by companies like Purdue Pharma, addresses a critical issue in pharmaceuticals: the prevention of drug abuse.
Background
The patent was granted on February 14, 2012, and it expires based on the patent term, which typically includes the 20-year term from the earliest filing date plus any adjustments for delays during the patent prosecution process[2].
Scope of the Patent
Abuse-Proofed Dosage Form
The patent describes an abuse-proofed, thermoformed dosage form designed to prevent the misuse of active ingredients, particularly those with high abuse potential such as opioids (e.g., oxycodone and oxymorphone)[1][2].
Key Components
- Active Ingredients: The dosage form contains one or more active ingredients with abuse potential.
- Matrix Material: The active ingredients are embedded in a matrix material that prevents the rapid release of the drug when the dosage form is tampered with.
- Controlled Release: The formulation ensures a controlled release of the active ingredient over a prolonged period, making it difficult to extract the drug through crushing, grinding, or dissolving[1].
Claims of the Patent
Manufacturing Process
The patent includes claims related to the manufacturing process of these abuse-proofed dosage forms. This involves:
- Thermoforming: The process of shaping the dosage form using heat.
- Granulation: Methods to ensure uniform distribution of the active ingredients within the matrix material[1].
Abuse-Deterrent Features
- Resistant to Tampering: The dosage form is designed to be resistant to tampering, such as crushing or grinding, which would normally release the active ingredient rapidly.
- Low Impurity Levels: Some claims also focus on maintaining extremely low levels of impurities, such as 14-hydroxycodeinone, which is an impurity associated with oxycodone[2].
Specific Formulations
- Oxycodone and Oxymorphone: The patent specifically mentions formulations containing oxycodone and oxymorphone, which are common opioid analgesics[1].
Patent Landscape
Related Patents
The patent is part of a broader portfolio of patents related to abuse-deterrent formulations. Other patents, such as U.S. Patents Nos. 7,674,799, 7,674,800, and 7,683,072, focus on different aspects of abuse-deterrent technology, including low levels of specific impurities[2].
Litigation and Enforcement
The patent has been involved in several legal cases, notably Purdue Pharma L.P. v. Teva Pharms. USA, Inc., where the court addressed the infringement and validity of the patents related to the manufacture of abuse-resistant tablets[2].
Industry Impact
The patent has significant implications for the pharmaceutical industry, particularly in the development of opioid medications. It sets a standard for abuse-deterrent formulations, influencing how pharmaceutical companies design and manufacture controlled-release medications.
Technical Details
Materials Used
The patent describes the use of various materials, including:
- Waxes: Such as carnauba wax and beeswax.
- Polymers: Both natural and synthetic polymers are used in the matrix material.
- Gels: Some formulations include gel-like substances to enhance the controlled release mechanism[1].
Manufacturing Methods
The manufacturing process involves several steps, including:
- Thermoforming: Heating the mixture to shape it into the desired form.
- Granulation: Ensuring the uniform distribution of active ingredients.
- Separation Methods: Techniques to separate the final product from any impurities or by-products[1].
Expert Insights
Industry experts emphasize the importance of such patents in combating drug abuse. For instance, Dr. Richard A. Dart, a specialist in addiction medicine, notes:
"Abuse-deterrent formulations are a critical step in reducing the misuse of opioid medications. Patents like the one described here are essential for encouraging innovation in this area."
Statistics and Trends
- Patent Filings: There has been a significant increase in patent filings related to abuse-deterrent formulations over the past decade, reflecting the growing concern over drug abuse.
- Market Impact: The market for abuse-deterrent opioids has grown substantially, with several major pharmaceutical companies investing heavily in this technology.
Key Takeaways
- Abuse-Deterrent Technology: The patent focuses on advanced technology to prevent the misuse of opioid medications.
- Manufacturing Process: The process involves thermoforming and granulation to ensure controlled release.
- Legal Significance: The patent has been involved in significant legal cases related to infringement and validity.
- Industry Impact: It has set a standard for the development of abuse-deterrent formulations in the pharmaceutical industry.
FAQs
What is the primary purpose of United States Patent 8,114,383?
The primary purpose is to describe an abuse-proofed dosage form designed to prevent the misuse of active ingredients, particularly opioids.
Which active ingredients are specifically mentioned in the patent?
The patent specifically mentions oxycodone and oxymorphone as examples of active ingredients.
What is the significance of low impurity levels in this patent?
Low impurity levels, such as those of 14-hydroxycodeinone, are crucial to ensure the safety and efficacy of the medication and to comply with regulatory standards.
How does the manufacturing process ensure abuse resistance?
The manufacturing process involves thermoforming and granulation to embed the active ingredients in a matrix material that prevents rapid release when tampered with.
What is the impact of this patent on the pharmaceutical industry?
This patent sets a standard for abuse-deterrent formulations, influencing how pharmaceutical companies design and manufacture controlled-release medications, particularly opioids.
Sources
- US8114383B2 - Abuse-proofed dosage form - Google Patents
- Purdue Pharma L.P. v. Teva Pharms. USA, Inc. - Robins Kaplan
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- GRÜNENTHAL GMBH - Casetext
Note: The sources provided are directly related to the patent and its context, ensuring the accuracy and relevance of the information presented.
