United States Patent 6,900,184: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,900,184, titled "Compositions containing piperacillin and tazobactam useful for injection," is a significant patent in the pharmaceutical industry, particularly in the context of antibacterial treatments. This patent, held by Wyeth Pharmaceuticals LLC, pertains to the formulation and composition of the drug Zosyn, which is a combination of piperacillin and tazobactam.
Scope and Claims
Pharmaceutical Composition
The patent describes pharmaceutical compositions that include piperacillin and tazobactam, which are antibacterial agents. These compositions are designed for injection and include a buffer, preferably citrate, and a particulate inhibitor such as EDTA (ethylenediaminetetraacetic acid) or a salt thereof[4].
Key Components
- Piperacillin and Tazobactam: The primary active ingredients, which work synergistically to broaden the spectrum of antibacterial activity.
- Buffer: Typically citrate, which helps maintain the stability and solubility of the active ingredients.
- Particulate Inhibitor: Such as EDTA, which prevents the formation of particulates in the solution, ensuring the stability and safety of the injection[4].
Claims
The patent includes several claims that define the scope of the invention:
- Claims related to the specific composition of piperacillin and tazobactam with a buffer.
- Claims related to the method of preparing these compositions.
- Claims related to the use of particulate inhibitors to maintain the stability of the solution[4].
Patent Landscape
Patent Expiry
The patent (US 6,900,184) expired on April 14, 2023. This expiry date is crucial as it allows for the development and approval of generic versions of the drug[2].
Related Patents
There are other patents related to the same drug composition, including US 7,915,229 and US 8,133,883, all of which have also expired on April 14, 2023. These patents cover similar aspects of the composition and preparation of piperacillin and tazobactam[2].
Generic Versions
The expiry of these patents has enabled the development and approval of generic versions of Zosyn. The first generic version was approved by Hospira Inc on September 15, 2009, and more recent approvals include those by Eugia Pharma Specialities Ltd on October 12, 2023[2].
Legal Activities and Updates
Recent Legal Activities
There have been several recent legal activities related to these patents, including maintenance fee payments, changes in power of attorney, and correspondence address changes. These activities are important for tracking the status and any potential extensions or changes to the patent life[2].
Notification and Certification
For generic applications, the applicant must notify the NDA holder and patent owner of the filing. This notification process is critical and must be documented, including proof of receipt by the patent owner. In the case of US 6,900,184, such notifications were made, and there was no patent infringement suit filed within the 45-day period following notification[1].
Impact on the Pharmaceutical Industry
Competition and Market Dynamics
The expiry of these patents has opened up the market for generic competitors, increasing competition and potentially reducing the cost of the drug. This is beneficial for patients and healthcare systems, as it provides more affordable treatment options.
Innovation and R&D
The patent landscape around piperacillin and tazobactam highlights the ongoing innovation in pharmaceutical formulations. Companies continue to develop new formulations and methods to improve the stability, efficacy, and safety of antibacterial treatments.
Conclusion
United States Patent 6,900,184 is a significant patent that has played a crucial role in the development and commercialization of the antibacterial drug Zosyn. With its expiry, the market has seen the introduction of generic versions, enhancing competition and affordability. Understanding the scope, claims, and patent landscape of this patent is essential for pharmaceutical companies, researchers, and regulatory bodies.
Key Takeaways
- The patent covers compositions of piperacillin and tazobactam for injection.
- Key components include a buffer and a particulate inhibitor.
- The patent expired on April 14, 2023, allowing for generic versions.
- Multiple generic versions have been approved since the patent expiry.
- Recent legal activities include maintenance fees and address changes.
FAQs
What is the primary use of the drug composition described in US 6,900,184?
The primary use is for treating bacterial infections through the combination of piperacillin and tazobactam.
Who was the original holder of US 6,900,184?
The original holder was Wyeth Pharmaceuticals LLC.
What is the significance of the buffer in the patent composition?
The buffer, typically citrate, helps maintain the stability and solubility of the active ingredients piperacillin and tazobactam.
What is the role of EDTA in the composition?
EDTA acts as a particulate inhibitor, preventing the formation of particulates in the solution and ensuring the stability and safety of the injection.
When did the first generic version of Zosyn get approved?
The first generic version was approved by Hospira Inc on September 15, 2009.
Cited Sources:
- FDA Document: "206829Orig1s000 - accessdata.fda.gov"
- Pharsight: "Piperacillin Sodium; Tazobactam Sodium Patent Expiration - Pharsight"
- WIPO: "Patent Landscape Report on Ritonavir - WIPO"
- Google Patents: "Compositions containing pipercillin and tazobactam useful for injection"
