United States Patent 11,433,044: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,433,044, titled "Pharmaceutical formulations for subcutaneous administration of furosemide," is a significant patent held by Scpharmaceuticals Inc. This patent is crucial for the drug Furoscix, which is a formulation of furosemide designed for subcutaneous administration. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Furosemide
Furosemide is a well-known diuretic used to treat fluid build-up (edema) and swelling that is caused by congestive heart failure, liver disease, a severe kidney disorder, or a kidney disorder called nephrotic syndrome. The innovation in the patent involves a new method of administration, specifically subcutaneous delivery, which offers potential advantages over traditional oral or intravenous routes.
Scope of the Patent
The patent US 11,433,044 focuses on pharmaceutical formulations designed for the subcutaneous administration of furosemide. Here are the key aspects of its scope:
Pharmaceutical Formulations
The patent describes specific formulations of furosemide that are highly soluble in water, such as the tris(hydroxymethyl)aminomethane salt of furosemide. This solubility is critical for effective subcutaneous delivery[1][2].
Mode of Administration
The primary innovation is the method of subcutaneous administration, which involves injecting the formulation under the skin rather than administering it orally or intravenously. This method can provide more consistent and controlled drug delivery.
Concentration and Composition
The patent details various concentrations and compositions of the furosemide formulations, ensuring stability and efficacy for subcutaneous use[1].
Claims of the Patent
The claims of the patent are the legal boundaries that define what is protected by the patent. Here are some key claims:
Independent Claims
The patent includes independent claims that describe the overall invention, such as the pharmaceutical formulation itself and the method of its subcutaneous administration. These claims are broad enough to cover the core innovation but specific enough to distinguish it from prior art[1].
Dependent Claims
Dependent claims further specify aspects of the invention, such as particular concentrations of furosemide, specific excipients, and detailed methods of preparation. These claims provide additional protection by covering various embodiments of the invention[1].
Patent Landscape
Understanding the broader patent landscape is crucial for assessing the strength and duration of the patent protection.
Exclusivity and Patent Protection
The patent US 11,433,044 is one of three active U.S. patents protecting Furoscix, with all three set to expire in April 2034. Additionally, Furoscix holds a New Product (NP) exclusivity that expires in October 2025. This exclusivity period, combined with the patent protection, ensures that Scpharmaceuticals Inc. maintains exclusive marketing rights for the drug in the United States until at least 2025[2].
International Protection
While the focus here is on U.S. patents, Furoscix is also protected by patents in multiple countries. Understanding the global patent landscape is essential for strategizing market entry and identifying potential generic entry points in regions with weaker patent protection[2].
Legal Activities and Patent Maintenance
The patent has undergone several legal activities, including the issuance of certificates of correction and the payment of maintenance fees. These activities are critical for maintaining the validity and enforceability of the patent[2].
Impact on Generic Launch
As of now, there is no therapeutically equivalent generic version of Furoscix available in the United States. The patent and exclusivity protections ensure that Scpharmaceuticals Inc. retains market exclusivity until the patents expire or any exclusivity periods end. Tracking ongoing legal activities and patent maintenance is essential for predicting when generic versions might become available[5].
Challenges and Risks
While the patent provides strong protection, there are risks and challenges associated with maintaining this protection. These include potential patent challenges in courts or patent offices, compliance with intellectual property licenses, and the impact of external factors such as the COVID-19 pandemic on business operations[4].
Key Takeaways
- Patent Scope: The patent covers pharmaceutical formulations for subcutaneous administration of furosemide, including specific solubility-enhancing salts.
- Claims: The patent includes independent and dependent claims that define the invention and its various embodiments.
- Patent Landscape: The patent is part of a broader protection strategy that includes multiple U.S. patents and international patents, along with exclusivity periods.
- Exclusivity: Furoscix holds a New Product exclusivity until October 2025 and patent protection until April 2034.
- Generic Launch: No generic version is currently available, and the timing of generic entry depends on the expiration of patents and exclusivity periods.
FAQs
Q: What is the primary innovation of the United States Patent 11,433,044?
A: The primary innovation is the development of pharmaceutical formulations for the subcutaneous administration of furosemide.
Q: When do the patents protecting Furoscix expire?
A: The patents protecting Furoscix are set to expire in April 2034.
Q: Does Furoscix have any exclusivity periods?
A: Yes, Furoscix holds a New Product (NP) exclusivity that expires in October 2025.
Q: Are there any generic versions of Furoscix available?
A: No, there are currently no therapeutically equivalent generic versions of Furoscix available in the United States.
Q: What are the risks associated with maintaining the patent protection for Furoscix?
A: Risks include potential patent challenges, compliance with intellectual property licenses, and external factors like the COVID-19 pandemic affecting business operations.
Sources
- US11433044B2 - Pharmaceutical formulations for subcutaneous administration of furosemide - Google Patents
- Furoscix patent expiration - Pharsight
- Patent Claims and Patent Scope - Hoover Institution
- Form 10-K for Scpharmaceuticals INC - Scpharmaceuticals Inc.
- Generic Furoscix Availability - Drugs.com
