Understanding the Scope and Claims of United States Patent 9,233,103 for Dexilant
Introduction to Dexilant and Patent Protection
Dexilant, a medication owned by Takeda Pharmaceuticals USA, Inc., is used to treat various gastrointestinal disorders. The drug is protected by a complex array of patents, which play a crucial role in delaying the entry of generic versions into the market. One of the key patents is United States Patent 9,233,103.
Overview of US Patent 9,233,103
Title and Inventors:
US Patent 9,233,103, titled "Methods for treating heartburn, gastric bleeding or hemorrhage in patients receiving clopidogrel therapy," was issued to inventors associated with Takeda Pharmaceuticals USA, Inc.[1][2].
Patent Claims and Scope
Primary Claims
The patent primarily covers methods for treating specific gastrointestinal conditions in patients who are also receiving clopidogrel therapy. Here are some key aspects of the claims:
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Therapeutic Methods: The patent details methods of administering a pharmaceutical composition containing dexlansoprazole, the active ingredient in Dexilant, to patients who are undergoing clopidogrel therapy. This is particularly important because clopidogrel, an antiplatelet medication, can interact with certain gastrointestinal treatments, and the patent addresses how to manage these interactions effectively[1][2].
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Patient Population: The claims are specific to patients suffering from heartburn, gastric bleeding, or hemorrhage, which are common complications in patients on clopidogrel therapy. The patent provides a tailored treatment approach for this specific patient population[1].
Scope Concepts
The scope of this patent can be broken down into several key concepts:
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Drug-Drug Interactions: The patent focuses on the interaction between dexlansoprazole and clopidogrel, ensuring that the treatment does not compromise the efficacy of either medication. This is a critical aspect as it addresses a significant clinical concern[1].
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Therapeutic Efficacy: The claims emphasize the effectiveness of dexlansoprazole in treating gastrointestinal disorders without interfering with the antiplatelet effects of clopidogrel. This ensures that patients receive comprehensive care without compromising their cardiovascular treatment[1].
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Administration Methods: The patent includes details on the administration of the drug, ensuring that it can be given independently of food intake, which enhances patient compliance and therapeutic outcomes[2].
Patent Expiration and Exclusivities
Patent Expiration Date
The patent is estimated to expire on March 5, 2032. This date is crucial as it marks the end of the exclusive rights granted to Takeda Pharmaceuticals USA, Inc., allowing for the potential entry of generic versions of Dexilant into the market[1][2].
FDA Exclusivities
In addition to patent protection, Dexilant is also protected by FDA-granted exclusivities. These exclusivities can run concurrently with or independently of patent protection and can further delay the launch of generic versions. The FDA has granted several exclusivities to Dexilant, which are active until the specified dates, ensuring that no generic or bioequivalent version can be marketed during this period[1].
Impact on Generic Launch
The expiration of US Patent 9,233,103, along with other patents and exclusivities, will significantly impact the generic launch of Dexilant. Here are some key points:
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Generic Entry: The estimated generic launch date for Dexilant is March 5, 2032, based on the expiration of this and other active patents. However, this date can be influenced by ongoing legal activities, such as patent litigation or term extensions[1][2].
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Market Competition: Once the patent expires, other pharmaceutical companies can develop and market generic versions of Dexilant, potentially increasing market competition and reducing the drug's price[1].
International Patent Landscape
While US Patent 9,233,103 is specific to the United States, Dexilant is protected by a broader international patent landscape. This includes patents in various countries such as South Korea, Israel, Mexico, and others. Understanding this global patent landscape is crucial for strategizing market entry and identifying potential gaps or opportunities for generic entry[1][4].
Legal Activities and Patent Maintenance
The life of a patent can be affected by various legal activities such as maintenance fee payments, oppositions, and litigation. For example, recent activities on Dexilant's patents include the payment of maintenance fees and the resolution of oppositions filed in the European Patent Office. These activities can influence the patent's expiration date and the timing of generic entry[1].
Conclusion
US Patent 9,233,103 is a critical component of the patent protection for Dexilant, covering specific therapeutic methods and ensuring the drug's efficacy in patients receiving clopidogrel therapy. Understanding the scope, claims, and expiration of this patent, along with other patents and exclusivities, is essential for pharmaceutical companies and stakeholders to navigate the complex landscape of drug development and market entry.
Key Takeaways
- Patent Scope: US Patent 9,233,103 covers methods for treating heartburn, gastric bleeding, or hemorrhage in patients on clopidogrel therapy.
- Expiration Date: The patent is estimated to expire on March 5, 2032.
- FDA Exclusivities: Additional exclusivities granted by the FDA further protect Dexilant from generic competition.
- International Landscape: Dexilant is protected by patents in multiple countries, affecting global market entry strategies.
- Legal Activities: Ongoing legal activities can influence the patent's expiration date and generic launch timing.
FAQs
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What is the primary focus of US Patent 9,233,103?
- The primary focus is on methods for treating heartburn, gastric bleeding, or hemorrhage in patients receiving clopidogrel therapy.
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When is the estimated expiration date of US Patent 9,233,103?
- The estimated expiration date is March 5, 2032.
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How do FDA exclusivities impact the generic launch of Dexilant?
- FDA exclusivities delay the launch of generic versions by granting sole marketing rights to the original manufacturer, regardless of patent status.
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What is the significance of the international patent landscape for Dexilant?
- Understanding the global patent landscape helps identify markets with weaker patent protection, which could be ideal for generic entry.
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How can legal activities affect the patent's expiration date?
- Activities such as maintenance fee payments, oppositions, and litigation can extend or shorten the patent's life, affecting the generic launch date.
Sources
- Pharsight: Dexilant patent expiration - Pharsight
- Drugs.com: Generic Dexilant Availability - Drugs.com
- SLWIP: Patent Analytics | Intellectual Property Law
- DrugPatentWatch: When will the DEXILANT patents expire, and ... - DrugPatentWatch
- PharmaCompass: US Patent 9233103 | Expiration | Dates - PharmaCompass.com
