Abuse-Resistant Pharmaceutical Composition for the Treatment of Opioid Dependence: A Detailed Analysis of US Patent 10,874,661
Introduction
The United States Patent 10,874,661, issued to Orexo AB, represents a significant advancement in the treatment of opioid dependence and addiction. This patent details innovative pharmaceutical compositions designed to prevent abuse and ensure effective treatment. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Context
Opioid dependence is a pervasive and complex issue, necessitating multifaceted treatment approaches. Traditional opioid treatments often come with the risk of abuse, which has driven the development of abuse-resistant formulations. The patent in question addresses this need by introducing specific pharmaceutical compositions that combine opioids with other components to deter misuse.
Patent Overview
Issuance and Assignee
The patent was issued on December 29, 2020, to Andreas Fischer, an inventor associated with Orexo AB, a Swedish pharmaceutical company[2][4].
Patent Expiration
The patent is set to expire on September 18, 2032, which is 20 years from the filing date of the original application[2].
Scope of the Patent
Pharmaceutical Composition
The patent describes pharmaceutical compositions for treating opioid dependency and/or pain. These compositions include microparticles of a pharmacologically-effective amount of buprenorphine, or a pharmaceutically-acceptable salt thereof, in associative admixture with particles comprising a weak acid or weakly-acidic buffer forming materials. The compositions may also include a disintegrant and/or particles of a pharmacologically-effective amount of naloxone, or a pharmaceutically-acceptable salt thereof[2][4].
Components and Their Roles
- Buprenorphine: A partial opioid agonist used to treat opioid dependence.
- Weak Acid or Weakly-Acidic Buffer Forming Materials: These components help in controlling the release of buprenorphine and preventing rapid increase in plasma concentration, which can be associated with abuse.
- Disintegrant: Enhances the disintegration of the tablet, ensuring the medication is released in a controlled manner.
- Naloxone: An opioid antagonist that can be included to further deter abuse by inducing withdrawal symptoms if the composition is tampered with or taken inappropriately[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- The composition includes microparticles of buprenorphine in associative admixture with particles of a weak acid or weakly-acidic buffer forming materials.
- The composition may further include a disintegrant and/or particles of naloxone.
- The specific ratios and forms of these components are detailed to ensure the desired pharmacological effects and abuse resistance[4].
Dependent Claims
These claims elaborate on the independent claims by specifying the types of weak acids, buffer forming materials, and the proportions of the components. They also describe the manufacturing process and the physical characteristics of the microparticles and tablets[4].
Patent Landscape
Related Patents
Orexo AB has a portfolio of patents related to abuse-resistant pharmaceutical compositions. For example:
- Patent 10,946,010: Issued on March 16, 2021, this patent also deals with similar compositions for opioid dependency treatment and has the same expiration date as Patent 10,874,661[2].
- Patent 8,470,361: Issued on June 25, 2013, this patent describes compositions for pain treatment using opioid analgesics and opioid antagonists, also aimed at preventing abuse[2].
Exclusivity and Generic Entry
The patent grants exclusive rights to Orexo AB until its expiration in 2032. After this period, generic versions of the composition can be developed and marketed, subject to FDA approval and other regulatory requirements[2].
Impact on Treatment and Abuse Prevention
The compositions described in this patent are designed to address two critical aspects:
- Effective Treatment: By ensuring a controlled release of buprenorphine, these compositions help in managing opioid dependence effectively.
- Abuse Prevention: The inclusion of weak acids, buffer forming materials, and naloxone deters individuals from tampering with the medication, thereby reducing the risk of abuse[4].
Industry Expert Insights
Industry experts highlight the importance of such formulations in combating the opioid crisis. For instance, Dr. Nora Volkow, Director of the National Institute on Drug Abuse, has emphasized the need for innovative treatments that not only manage addiction but also prevent abuse.
Statistics and Market Impact
- Opioid Crisis: The opioid epidemic has resulted in significant healthcare and economic burdens. According to the CDC, opioid overdoses have claimed hundreds of thousands of lives in the U.S. alone.
- Market Demand: The demand for abuse-resistant opioid treatments is high, driven by both regulatory pressures and the need for effective solutions. This patent positions Orexo AB as a leader in this market segment.
Key Takeaways
- Innovative Composition: The patent describes a unique composition combining buprenorphine with weak acids, buffer forming materials, and naloxone to treat opioid dependence.
- Abuse Resistance: The design of the composition is aimed at preventing abuse by controlling the release of the active ingredients.
- Patent Exclusivity: Orexo AB holds exclusive rights until the patent expires in 2032.
- Industry Impact: This invention is crucial in the fight against opioid abuse and dependence, offering a safer and more effective treatment option.
FAQs
What is the main component of the pharmaceutical composition described in US Patent 10,874,661?
The main component is buprenorphine, a partial opioid agonist, combined with weak acids or weakly-acidic buffer forming materials and optionally naloxone.
How does the composition prevent abuse?
The composition prevents abuse by controlling the release of buprenorphine through the use of weak acids and buffer forming materials, and by including naloxone, which induces withdrawal symptoms if the medication is tampered with.
Who is the assignee of the patent?
The assignee of the patent is Orexo AB, a Swedish pharmaceutical company.
When does the patent expire?
The patent expires on September 18, 2032.
What other patents are related to this invention?
Related patents include US Patent 10,946,010 and US Patent 8,470,361, also issued to Orexo AB, which deal with similar abuse-resistant pharmaceutical compositions.
References
- United States Patent and Trademark Office, "Abuse-resistant pharmaceutical composition for the treatment of opioid dependence," US Patent 10,874,661 B2, issued December 29, 2020.
- Drugs.com, "Generic Zubsolv Availability," accessed November 6, 2024.
- SSRN, "Patent Claims and Patent Scope," accessed September 29, 2016.
- Google Patents, "Abuse-resistant pharmaceutical composition for the treatment of opioid dependence," US Patent 10,874,661 B2.
- Drug Patent Watch, "Patent 10,874,661," accessed November 2024.
- National Institute on Drug Abuse, "Director's Blog," accessed 2024.
- CDC, "Opioid Overdose," accessed 2024.
