United States Patent 8,133,893: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,133,893, titled "Trazodone and trazodone hydrochloride in purified form," is a significant patent in the pharmaceutical industry, particularly in the production and purification of trazodone and its hydrochloride salt. This article delves into the scope, claims, and the broader patent landscape surrounding this patent.
Background of Trazodone
Trazodone is an antidepressant medication used to treat major depressive disorder and other conditions. Its hydrochloride salt is commonly used in pharmaceutical formulations due to its improved solubility and stability.
Patent Overview
Publication and Legal Status
The patent was published on March 6, 2012, and is currently active, with an expiration date based on the patent term[1][2].
Inventors and Assignees
The patent lists specific inventors and assignees who have contributed to the development of the process described in the patent.
Scope of the Patent
Process Description
The patent outlines a detailed process for the production and purification of trazodone and its hydrochloride salt. This process involves several key steps:
- Preparing an organic phase comprising trazodone.
- Using phase transfer catalysts and specific solvents to enhance purification.
- Employing heat treatment and mixing methods to ensure high purity.
- Utilizing aqueous and organic phases to separate and crystallize the product[1][2].
Key Components and Solvents
The process involves various organic solvents such as acetone, ethanol, ethyl acetate, and diethyl ether. It also includes the use of phase transfer catalysts like tetrabutylammonium chloride and tributyl(methyl)azanium chloride[1].
Claims of the Patent
Independent and Dependent Claims
The patent includes multiple claims, both independent and dependent, which define the scope of the invention. Independent claims outline the core process steps, while dependent claims provide additional details and variations of the process. For example, Claim 1 describes the general process of preparing trazodone hydrochloride, while subsequent claims detail specific conditions and reagents used[1].
Claim Language and Scope
The claim language is crucial in defining the patent's scope. The patent's claims are structured to cover various aspects of the production process, ensuring broad protection while maintaining clarity. The use of specific claim language helps in distinguishing the invention from prior art and other related processes[3].
Patent Landscape
International Patents
Trazodone hydrochloride is protected by numerous international patents, with filings in countries such as Brazil, South Africa, Canada, and Denmark. These patents cover various aspects of trazodone production, formulation, and administration[4].
US Patents and Applications
In the United States, there are multiple patents and patent applications related to trazodone hydrochloride. These include patents for extended-release formulations, once-a-day administration compositions, and other specific pharmaceutical compositions[4].
Patent Litigation and PTAB Cases
The patent landscape for trazodone hydrochloride includes several litigation and PTAB (Patent Trial and Appeal Board) cases. For instance, Aurobindo Pharma USA Inc. has been involved in ANDA (Abbreviated New Drug Application) litigation related to this patent[5].
Technological and Regulatory Trends
Production Technologies
Advancements in production technologies, such as improved purification methods and the use of phase transfer catalysts, have been crucial in enhancing the efficiency and purity of trazodone hydrochloride production. These technologies are reflected in the patent's detailed process descriptions[1].
Regulatory Compliance
The patent and related filings must comply with regulatory requirements set by agencies such as the FDA. This includes adherence to Good Manufacturing Practices (GMP) and other pharmaceutical standards. The patent's focus on purification and stability ensures compliance with these regulations[4].
Impact on Innovation and Market
Patent Scope and Innovation
The scope of the patent, as defined by its claims, can influence innovation in the field. Narrower claims, as seen in this patent, can facilitate a shorter examination process and higher grant probability, encouraging further innovation by providing clear boundaries for other inventors[3].
Market Dynamics
The patent landscape for trazodone hydrochloride affects market dynamics, particularly in terms of generic drug entry. The expiration of key patents can open the market to generic versions, impacting the pricing and availability of the drug. The presence of multiple patent filings and litigation cases indicates a competitive market where companies are vying for market share[4].
Conclusion
The United States Patent 8,133,893 is a critical patent in the pharmaceutical industry, detailing a comprehensive process for the production and purification of trazodone and its hydrochloride salt. The patent's scope, defined by its claims, is broad yet specific, ensuring protection for the inventors while providing clarity for other stakeholders.
Key Takeaways
- Detailed Process: The patent outlines a detailed process involving organic and aqueous phases, phase transfer catalysts, and specific solvents.
- International Protection: Trazodone hydrochloride is protected by numerous international patents.
- US Patent Landscape: Multiple US patents and applications cover various aspects of trazodone production and formulation.
- Litigation and PTAB Cases: Several litigation and PTAB cases are associated with this patent.
- Technological and Regulatory Trends: The patent reflects advancements in production technologies and compliance with regulatory standards.
- Impact on Innovation and Market: The patent's scope influences innovation and market dynamics, particularly in terms of generic drug entry.
FAQs
Q: What is the primary focus of United States Patent 8,133,893?
A: The primary focus is on the production and purification process of trazodone and its hydrochloride salt.
Q: What are some key components and solvents used in the process described in the patent?
A: The process involves organic solvents like acetone, ethanol, ethyl acetate, and diethyl ether, as well as phase transfer catalysts such as tetrabutylammonium chloride.
Q: How does the patent landscape for trazodone hydrochloride affect market dynamics?
A: The patent landscape influences market dynamics by affecting the entry of generic drugs, pricing, and availability of the drug.
Q: What is the significance of claim language in defining the patent's scope?
A: The claim language is crucial in defining the patent's scope, ensuring broad protection while maintaining clarity and distinguishing the invention from prior art.
Q: Are there any international patents related to trazodone hydrochloride?
A: Yes, there are numerous international patents filed in countries such as Brazil, South Africa, Canada, and Denmark.
Sources
- US8133893B2 - Trazodone and trazodone hydrochloride in purified form - Google Patents
- Analytics for US Patent No. 8133893, Trazodone and trazodone hydrochloride - PatentBuddy
- Patent Claims and Patent Scope - SSRN
- Trazodone hydrochloride - Generic Drug Details - DrugPatentWatch
- Aurobindo Pharma USA Inc. - RPX Insight
