United States Patent 9,339,489: A Detailed Analysis
Overview of the Patent
United States Patent 9,339,489, titled "Rapid disperse dosage form containing levetiracetam," was issued on May 17, 2016, to Aprecia Pharmaceuticals Company. This patent revolves around a novel dosage form designed for rapid dispersion, specifically containing the drug levetiracetam, which is used to treat conditions such as epilepsy.
Inventors and Assignees
The patent was invented by a team of researchers including Jacob Jules, Coyle Norman, West Thomas G., Monkhouse Donald C., Surprenant Henry L., and Jain Nemichand B., all associated with Aprecia Pharmaceuticals Company[5].
Claims and Description
Dosage Form
The patent describes a high dose rapidly dispersing three-dimensionally printed dosage form. This dosage form is characterized by its ability to disperse in water within a period of less than about 10 seconds, making it highly convenient for patients, especially those with difficulty swallowing traditional tablets[4][5].
Porous Matrix
The dosage form is composed of a porous matrix that contains a high dose of levetiracetam. This matrix is designed to disintegrate quickly when exposed to water, releasing the drug for rapid absorption.
Methods of Preparation
The patent also discloses methods of preparing the dosage form, which involve three-dimensional printing techniques. This innovative manufacturing process allows for the creation of complex structures that enhance the rapid dispersion of the drug.
Therapeutic Applications
The dosage form is intended for treating conditions, diseases, or disorders that are therapeutically responsive to levetiracetam. This includes various types of epilepsy and other neurological disorders.
Patent Scope and Claims
The patent claims are broad and cover several key aspects:
- The composition of the dosage form, including the porous matrix and the high dose of levetiracetam.
- The method of preparing the dosage form using three-dimensional printing.
- The rapid dispersion characteristics of the dosage form.
- The therapeutic applications of the dosage form.
These claims are designed to protect the proprietary technology and formulation developed by Aprecia Pharmaceuticals Company.
Patent Expiration Dates
The patent is set to expire on March 14, 2034, which is approximately 20 years from the date of filing, consistent with standard patent durations[5].
Patent Landscape Analysis
Competitive Landscape
A patent landscape analysis for this technology area reveals a highly specialized and innovative segment within the pharmaceutical industry. Aprecia Pharmaceuticals Company is a key player in this niche, with multiple patents related to rapid disperse dosage forms.
Prior Art and Related Patents
The patent cites several prior art documents, including earlier patents related to dosage forms and drug delivery systems. For example, patents such as US9339489B2 and US9166018B2 are referenced, indicating a continuous evolution in the field of rapid disperse dosage forms[2][4].
Strategic Insights
A comprehensive patent landscape analysis would help business and R&D management at Aprecia Pharmaceuticals Company and other competitors to make strategic decisions. This includes identifying areas of high patent saturation and potential opportunities to pivot into newer inventive spaces. For instance, the analysis might show that while the technology area is highly saturated, there are still opportunities for innovation in specific niches, such as improving the dispersion time or expanding the range of drugs that can be used in these dosage forms[3].
Going Beyond Known Competitors
The analysis would also involve looking beyond known competitors to identify emerging players and potential disruptors in the market. This could include startups or research institutions that are developing similar technologies. By mapping abandoned and active technology patents, companies can gain insights into where the industry is heading and where they should focus their research and development efforts[3].
Impact on the Pharmaceutical Industry
The patent has significant implications for the pharmaceutical industry, particularly in the area of drug delivery systems. The rapid disperse dosage form offers several advantages, including improved patient compliance and faster drug absorption. This technology can be particularly beneficial for patients with swallowing difficulties, such as the elderly or those with certain neurological conditions.
Regulatory and Market Considerations
The patent holder, Aprecia Pharmaceuticals Company, enjoys exclusive marketing rights for this specific dosage form. However, the absence of generic versions, as noted for the drug Spritam (another product from Aprecia), indicates that the market remains protected by this and related patents[5].
Key Takeaways
- Innovative Dosage Form: The patent describes a novel, rapidly dispersing dosage form containing levetiracetam, manufactured using three-dimensional printing.
- Therapeutic Applications: The dosage form is designed for treating epilepsy and other neurological disorders.
- Patent Scope: The claims cover the composition, preparation method, and therapeutic applications of the dosage form.
- Patent Expiration: The patent is set to expire on March 14, 2034.
- Competitive Landscape: Aprecia Pharmaceuticals Company is a key player in this niche, with multiple related patents.
- Strategic Insights: A comprehensive patent landscape analysis can help identify opportunities and challenges in this highly specialized segment.
FAQs
What is the main innovation of United States Patent 9,339,489?
The main innovation is the development of a rapidly dispersing three-dimensionally printed dosage form containing levetiracetam, which disperses in water within 10 seconds.
Who are the inventors and assignees of this patent?
The inventors include Jacob Jules, Coyle Norman, West Thomas G., Monkhouse Donald C., Surprenant Henry L., and Jain Nemichand B., with Aprecia Pharmaceuticals Company as the assignee.
What are the therapeutic applications of this dosage form?
The dosage form is intended for treating conditions, diseases, or disorders that are therapeutically responsive to levetiracetam, including various types of epilepsy.
How does the patent landscape analysis help in this context?
A patent landscape analysis helps in identifying areas of high patent saturation, potential opportunities for innovation, and strategic insights for long-term decisions in technology development.
When is the patent set to expire?
The patent is set to expire on March 14, 2034.
Cited Sources
- NYPL Libguides: How to Search for an Historical U.S. Patent.
- Google Patents: United States Patent - US11433022.
- AcclaimIP: Patent Landscape Analysis - Uncovering Strategic Insights.
- Google Patents: US9339489B2 - Rapid disperse dosage form containing levetiracetam.
- Drugs.com: Generic Spritam Availability.
