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Patent landscape, scope, and claims: |
United States Patent 8,541,448: A Detailed Analysis of Scope and Claims
Overview of the Patent
United States Patent 8,541,448, assigned to Ardelyx, Inc., is a significant patent in the pharmaceutical industry, particularly in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders. Here is a detailed analysis of its scope, claims, and the broader patent landscape.
Patent Title and Description
The patent, titled "Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders," was issued on September 24, 2013. It describes compounds and methods for treating various conditions, including congestive heart failure, chronic kidney disease, end-stage renal disease, liver disease, and gastrointestinal tract disorders[2].
Inventors and Assignees
The inventors listed on the patent include Dominique Charmot, Jeffrey W. Jacobs, Michael Robert Leadbetter, Marc Navre, Christopher Carreras, and Noah Bell. The assignee is Ardelyx, Inc.[2].
Claims
The patent includes multiple claims that cover various aspects of the invention:
- Compound Claims: These claims describe the specific chemical structures of the compounds used to inhibit NHE (sodium-hydrogen exchanger) activity. The compounds are designed to move sodium ions out of cells while bringing hydrogen ions in, a mechanism crucial for treating fluid retention and salt overload disorders[2].
- Method Claims: These claims outline the methods for using the compounds to treat various medical conditions. This includes administering the compounds to patients suffering from heart failure, kidney disease, liver disease, and gastrointestinal disorders[2].
- Use Claims: These claims specify the therapeutic uses of the compounds, such as reducing fluid retention in congestive heart failure patients and treating irritable bowel syndrome[2].
Patent Scope
The scope of the patent is broad, covering a range of therapeutic applications and chemical formulations.
- Therapeutic Applications: The patent covers treatments for several serious medical conditions, including congestive heart failure, chronic kidney disease, end-stage renal disease, liver disease, and gastrointestinal tract disorders. This broad therapeutic scope indicates the potential versatility and impact of the invention[2].
- Chemical Formulations: The patent describes specific chemical structures and their methods of synthesis, ensuring that any similar compounds developed by other entities would infringe on these claims unless they significantly differ in structure or function[2].
Patent Expiration
The patent is set to expire on August 1, 2033. This expiration date is significant because it marks the end of Ardelyx's exclusive rights to the invention, after which generic versions of the drug could be developed and marketed[2].
Related Patents and Exclusivities
Ardelyx has a portfolio of related patents that complement this invention. For example:
- Patent 9,006,281: This patent, issued on April 14, 2015, also covers compounds and methods for inhibiting NHE-mediated antiport, with a focus on treating irritable bowel syndrome, chronic kidney disease, and end-stage renal disease. It expires on May 2, 2030[2].
- Patent 9,408,840: Issued on August 9, 2016, this patent describes similar compounds and methods, with an expiration date of December 30, 2029[2].
FDA Exclusivities
In addition to patent protection, Ardelyx has been granted FDA exclusivities. For instance, the FDA has granted a New Chemical Entity (NCE) exclusivity for IBSRELA (tenapanor), which expires on September 12, 2024. This exclusivity period runs concurrently with the patent but provides additional protection against generic competition[2].
Impact on the Pharmaceutical Industry
Innovation and Competition
The patent and its related exclusivities have significant implications for innovation and competition in the pharmaceutical industry. The exclusive rights granted to Ardelyx allow the company to recoup its investment in research and development, which is crucial for the development of new drugs. However, once the patent expires, other companies can develop generic versions, potentially increasing competition and reducing costs for patients[2].
Economic Considerations
Ardelyx's patent portfolio, including US 8,541,448, has contributed to the company's revenue. For example, in 2021, Ardelyx generated $10.1 million in revenue, largely from the sales of its patented drugs like IBSRELA and XPHOZAH[1].
Conclusion
United States Patent 8,541,448 is a critical component of Ardelyx's intellectual property portfolio, providing exclusive rights to compounds and methods for treating various medical conditions. The patent's broad scope and therapeutic applications underscore its importance in the pharmaceutical industry. As the patent approaches its expiration date, it is likely that generic versions of the drug will emerge, changing the competitive landscape and potentially benefiting patients through reduced costs.
Key Takeaways
- Patent Scope: Covers compounds and methods for inhibiting NHE-mediated antiport in treating fluid retention and gastrointestinal disorders.
- Expiration Date: August 1, 2033.
- Therapeutic Applications: Includes treatments for congestive heart failure, chronic kidney disease, and gastrointestinal tract disorders.
- Related Patents: Part of a broader portfolio of patents and FDA exclusivities held by Ardelyx.
- Impact on Industry: Provides exclusive rights to Ardelyx, influencing innovation and competition in the pharmaceutical sector.
FAQs
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What is the main focus of United States Patent 8,541,448?
- The patent focuses on compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders.
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Who are the inventors listed on the patent?
- The inventors include Dominique Charmot, Jeffrey W. Jacobs, Michael Robert Leadbetter, Marc Navre, Christopher Carreras, and Noah Bell.
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What is the expiration date of the patent?
- The patent is set to expire on August 1, 2033.
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What are the therapeutic applications covered by the patent?
- The patent covers treatments for congestive heart failure, chronic kidney disease, end-stage renal disease, liver disease, and gastrointestinal tract disorders.
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Does Ardelyx have any related patents or exclusivities?
- Yes, Ardelyx has a portfolio of related patents and FDA exclusivities, including NCE exclusivity for IBSRELA, which expires on September 12, 2024.
Sources
- Ardelyx Patents - Insights & Stats - Insights & Stats, Greyb.
- Generic Ibsrela Availability - Drugs.com.
- Patent Claims and Patent Scope - Hoover Institution.
- Form 10-K for Ardelyx INC - Ardelyx, Inc.
- REVISED NOTICE OF FINAL DETERMINATION - Regulations.gov.
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