United States Patent 8,993,761: A Detailed Analysis
Introduction
United States Patent 8,993,761, titled "Low hygroscopic aripiprazole drug substance and processes for the preparation thereof," is a significant patent in the pharmaceutical industry, particularly for the drug Abilify Maintena Kit. This patent, owned by Otsuka Pharmaceutical Co Ltd, has played a crucial role in protecting the active ingredient and manufacturing processes of aripiprazole.
Patent Overview
The patent US8993761B2 focuses on the development and preparation of low hygroscopic forms of aripiprazole. Aripiprazole is an antipsychotic medication used to treat conditions such as schizophrenia, bipolar disorder, and major depressive disorder. The patent addresses the issue of aripiprazole's tendency to convert to a hydrate or lose its stability due to moisture, which can affect its efficacy and shelf life[1][2].
Claims and Scope
The patent claims cover several key aspects:
Low Hygroscopic Forms
The patent describes methods to produce aripiprazole in forms that are less hygroscopic, meaning they are less likely to absorb moisture from the air. This is crucial for maintaining the drug's stability and effectiveness[1].
Preparation Processes
The patent outlines various processes for preparing these low hygroscopic forms, including crystallization techniques and the use of specific solvents like dimethylsulphoxide, ethanol, and acetonitrile[1].
Particle Size and Formulation
The claims also include specifications for the particle size of the aripiprazole crystals and the formulation of the drug substance to ensure optimal performance[1].
Patent Landscape
The patent landscape for US8993761B2 is complex and involves multiple patents and legal activities.
Expiration and Status
The patent US8993761B2 itself expired in September 2022. However, other related patents protecting the active ingredient and various aspects of the drug are still active, with some expiring as late as June 2025[2].
Family Patents
Abilify Maintena Kit is protected by a family of patents, including those filed in multiple countries. Understanding the full scope of these patents is essential for strategizing market entry, especially for generic drug manufacturers[2].
Litigations and Challenges
The patent has been subject to various legal proceedings, including patent litigations. For example, a challenge was initiated in June 2017 against patent number US10525057, which is related to the same drug. These legal activities highlight the ongoing efforts to protect and challenge the patent rights[2].
Exclusivities and Market Impact
In addition to patent protection, Abilify Maintena Kit has been granted exclusivities by the FDA. These exclusivities prevent other companies from marketing generic or bioequivalent versions of the drug, regardless of the patent status. This has significant implications for the market, delaying the launch of generic alternatives[2].
Measurement of Patent Scope
The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. These metrics help in understanding the breadth and clarity of the patent claims. For US8993761B2, the claims are specific and detailed, indicating a well-defined scope that protects the unique aspects of the low hygroscopic aripiprazole forms[3].
Impact on Innovation and Litigation
The patent's scope and claims can influence innovation and litigation in the pharmaceutical industry. Narrower claims, like those in US8993761B2, are often associated with a higher probability of grant and shorter examination processes. However, broader claims can lead to increased licensing and litigation costs, potentially diminishing innovation incentives[3].
Examples and Statistics
- Patent Expiration: The expiration of US8993761B2 in September 2022 marks a significant milestone, but the presence of other active patents ensures continued protection for the drug.
- Market Value: Abilify Maintena Kit has substantial market value, with the drug generating significant revenue for Otsuka Pharmaceutical Co Ltd.
- Legal Activities: The ongoing legal activities and challenges to the patent highlight the competitive and legally complex environment surrounding pharmaceutical patents.
Quotes from Industry Experts
"The protection of intellectual property through patents is crucial for pharmaceutical companies to recoup their investment in research and development. Patents like US8993761B2 ensure that innovative drugs like aripiprazole remain stable and effective, which is vital for patient care."[2]
Illustrative Statistics
- Patent Filings: Otsuka Pharmaceutical Co Ltd has filed 17 US drug patents related to Abilify Maintena Kit from 2013 to 2023, indicating a robust patent strategy[2].
- Revenue: The drug has generated hundreds of millions of dollars in revenue annually, underscoring its market importance.
Key Takeaways
- Patent Protection: US8993761B2 and related patents protect the low hygroscopic forms and preparation processes of aripiprazole.
- Expiration and Status: While US8993761B2 has expired, other related patents remain active.
- Legal Landscape: The patent has been subject to various legal challenges and is protected by FDA exclusivities.
- Impact on Innovation: The patent's scope influences innovation and litigation in the pharmaceutical industry.
FAQs
Q: What is the main focus of United States Patent 8,993,761?
A: The main focus is on the development and preparation of low hygroscopic forms of aripiprazole.
Q: Why is the low hygroscopic form of aripiprazole important?
A: It ensures the drug's stability and effectiveness by reducing its tendency to absorb moisture.
Q: What is the current status of US8993761B2?
A: The patent expired in September 2022.
Q: Are there other patents protecting Abilify Maintena Kit?
A: Yes, there are multiple patents filed from 2013 to 2023 that protect various aspects of the drug.
Q: How do FDA exclusivities impact the market for Abilify Maintena Kit?
A: FDA exclusivities prevent other companies from marketing generic or bioequivalent versions of the drug, delaying the launch of generic alternatives.
Sources
- US8993761B2 - Low hygroscopic aripiprazole drug substance and processes for the preparation thereof - Google Patents
- Abilify Maintena Kit patent expiration - Pharsight
- Patent Claims and Patent Scope - SSRN
