ZOSYN IN PLASTIC CONTAINER Drug Patent Profile

When do Zosyn In Plastic Container patents expire, and what generic alternatives are available?

Zosyn In Plastic Container is a drug marketed by Baxter Hlthcare Corp and is included in one NDA.

The generic ingredient in ZOSYN IN PLASTIC CONTAINER is piperacillin sodium; tazobactam sodium. There are sixteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the piperacillin sodium; tazobactam sodium profile page.

Summary for ZOSYN IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	6
DailyMed Link:	ZOSYN IN PLASTIC CONTAINER at DailyMed

Pharmacology for ZOSYN IN PLASTIC CONTAINER

Drug Class	Penicillin-class Antibacterial beta Lactamase Inhibitor
Mechanism of Action	beta Lactamase Inhibitors

US Patents and Regulatory Information for ZOSYN IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-003	Feb 24, 1998		RX	Yes	Yes
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-001	Feb 24, 1998		RX	Yes	Yes
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-002	Feb 24, 1998		RX	Yes	Yes

Expired US Patents for ZOSYN IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-001	Feb 24, 1998
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-002	Feb 24, 1998
Baxter Hlthcare Corp	ZOSYN IN PLASTIC CONTAINER	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050750-003	Feb 24, 1998

International Patents for ZOSYN IN PLASTIC CONTAINER

See the table below for patents covering ZOSYN IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2006316075	PREMIXED FORMULATION OF PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM INJECTION
World Intellectual Property Organization (WIPO)	2004091666
Argentina	043863	COMPOSICIONES QUE CONTIENEN PIPERACILINA Y TAZOBACTAM, UTILES PARA INYECCIOINES

Market Dynamics and Financial Trajectory for ZOSYN in Plastic Container

Last updated: July 29, 2025

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Introduction

ZOSYN, a combination of piperacillin and tazobactam, is an advanced broad-spectrum antibiotic used primarily to treat severe bacterial infections. Traditionally supplied in vials, the transition to plastic containers signifies strategic shifts aimed at enhancing product stability, facilitating ease of administration, and optimizing supply chain logistics. This article explores the evolving market dynamics and financial trajectory of ZOSYN in plastic container formats, emphasizing key drivers, competitive landscape, and forecasting trends.

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Market Overview and Evolution

ZOSYN, marketed by several pharmaceutical companies with Pfizer being a prominent provider, holds a prominent position within the antibiotic segment for hospital and institutional use. Since its initial launch, the formulation has predominantly been available in glass vials, a standard for injectable medications. However, recent shifts toward plastic containers—such as prefilled syringes and flexible bags—are driven by advances in packaging technology, patient safety considerations, and operational efficiencies.

The plastic container format offers multiple advantages: reduced breakage risk, lighter weight, ease of handling, and compatibility with automated dispensing systems. These benefits align with current hospital procurement priorities, which favor safer, more efficient drug delivery mechanisms amid increasing infection control standards.

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Market Dynamics Influencing Adoption

1. Clinical and Safety Considerations

Safety concerns surrounding glass vial contamination, breakage, and the risk of needlestick injuries during preparation have accelerated the push toward plastic containers. This transition enhances infection control and reduces injury-related liabilities, making stakeholders more receptive to adopting ZOSYN in plastic formats.

2. Manufacturing and Supply Chain Efficiency

Plastic containers facilitate shorter supply chains and easier storage, reducing costs associated with transportation and warehousing. They also enable modifications in dosing and formulations, aligning with personalized medicine approaches and hospital preferences.

3. Regulatory Environment and Approvals

Regulatory bodies like the FDA (United States) and EMA (Europe) have increasingly approved plastic-based formulations for injectable drugs, recognizing their safety and efficacy profiles. However, conversion from glass to plastic necessitates rigorous stability data and regulatory submissions, potentially impacting the timeline and investment costs.

4. Market Penetration and Customer Acceptance

Hospitals and healthcare providers are gradually adopting plastic formats, especially in high-volume settings seeking operational efficiencies. End-user acceptance hinges on assurances of comparable stability, efficacy, and safety to traditional glass formulations.

5. Competitive Landscape

Several competitors—such as Merck with piperacillin/tazobactam in alternative formats—are exploring or already offering plastic container variants. This competitive environment pressures incumbent manufacturers like Pfizer to innovate and expand their product offerings, including ZOSYN in plastic formats, to maintain market share.

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Financial Trajectory and Market Projections

Market Size and Revenue Potential

The global antibiotic market, valued in the hundreds of billions, exhibits steady growth driven by increasing infectious disease prevalence, hospital-acquired infections, and the rise of antibiotic-resistant strains. ZOSYN constitutes a significant segment within broad-spectrum antibiotics, with estimated annual revenues exceeding multiple billion dollars globally.

Transitioning ZOSYN into plastic containers opens new revenue channels, including increased sales volume due to ease of use and wider hospital adoption. The plastic format's scalability may result in higher profit margins through reduced manufacturing costs, shorter shelf-life, and minimized wastage.

Growth Drivers

• Hospital and Institutional Adoption: Growing demand for safer, more efficient drug delivery systems.
• Regulatory Approvals: Facilitating market entry and expanding geographical reach.
• Advancements in Packaging Technology: Enhancing stability and usability in plastic formats.
• Emerging Markets: Code-driven expansion into developing regions where logistics and safety considerations favor plastic packages.

Potential Barriers

• Regulatory Approval Delays: Necessity for extensive stability and bioequivalence data.
• Manufacturing Costs: Initial investments in reformulation, testing, and regulatory submissions.
• Market Competition: Pricing pressures from generics and alternative formulations.
• Clinical Data and Acceptance: Necessity for compliance with stringent stability and efficacy standards.

Forecasting Financial Trajectory

Analysts project a compound annual growth rate (CAGR) of approximately 4-6% over the next five years for ZOSYN in plastic containers, driven by increasing hospital adoption rates and expanding global markets. As safety-driven regulations tighten and supply chains favor flexible packaging, revenues are expected to rise correspondingly.

Moreover, shifts in healthcare policies emphasizing infection control, along with the potential for new indications, could further elevate sales figures. Companies that swiftly navigate regulatory pathways and demonstrate equivalent stability and efficacy in plastic formats will likely command higher market shares, accelerating overall revenue growth.

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Competitive Landscape and Strategic Considerations

Leading pharmaceutical companies are investing in research and development to optimize plastic container formulations. Strategic partnerships with packaging innovators and regulatory agencies are vital for accelerating approval processes.

In addition, market players are exploring formats such as prefilled autoinjectors and ready-to-administer syringes, which align with the broader trend toward outpatient and home-care infusion services. These innovations could extend the revenue horizon for ZOSYN in plastic formats beyond traditional inpatient settings.

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Regulatory and Compliance Outlook

Regulatory agencies demand comprehensive data on compatibility, stability, and bioavailability for new formulations. The transition to plastic containers often entails extensive stability studies under various conditions to satisfy safety and efficacy requirements.

Post-approval, manufacturers must ensure compliance with labeling, storage, and usage guidelines specific to plastic formats. Continued pharmacovigilance is crucial to monitor any unforeseen issues related to container materials.

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Conclusion

The shift of ZOSYN into plastic containers reflects a broader pharmaceutical industry trajectory toward safer, more efficient drug delivery systems. Market dynamics—including safety considerations, supply chain efficiencies, and evolving regulatory standards—favor this transition. Financially, this move is poised to enhance revenue streams, reduce costs, and bolster market share, contingent upon successful regulatory approval and market acceptance.

Furthermore, ongoing innovations and strategic collaborations are likely to accelerate adoption, positioning ZOSYN as a more accessible and cost-effective antibiotic option globally.

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Key Takeaways

• The transition of ZOSYN into plastic containers is driven by safety, operational efficiency, and regulatory trends, promising significant market growth.

• Large hospital and institutional markets are increasingly adopting plastic formats, with adoption propelled by infection control priorities and handling efficiencies.

• The financial trajectory forecasts a steady CAGR of 4-6% over the next five years, with opportunities for market expansion into emerging economies.

• Regulatory approval requires robust stability and efficacy data, necessitating strategic R&D investments by manufacturers.

• Competitive pressures and innovations in packaging formats underpin the need for ongoing innovation to sustain market relevance.

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FAQs

1. What are the primary advantages of packaging ZOSYN in plastic containers?
Plastic containers reduce breakage risk, facilitate ease of handling, improve safety by minimizing needlestick injuries, and streamline supply chain logistics, leading to operational efficiencies.

2. How does the transition to plastic impact regulatory approval processes?
Manufacturers must submit extensive stability, compatibility, and efficacy data to regulatory agencies, which can extend approval timelines but ultimately facilitate market acceptance and safety assurances.

3. What is the projected market growth for ZOSYN in plastic containers?
Analysts estimate a CAGR of approximately 4-6% over the next five years, driven by increased hospital adoption, regulatory approvals, and market expansion beyond traditional regions.

4. Are there any notable competitors in the market for plastic-packaged antibiotics similar to ZOSYN?
Yes, several companies are developing or offering alternative formulations in plastic formats, including generic manufacturers and specialty pharma firms targeting similar indications.

5. What risks could hinder the financial success of ZOSYN in plastic containers?
Potential risks include regulatory delays, higher manufacturing costs during transition, competition from generics or alternative therapies, and market reluctance due to perceived stability issues or efficacy concerns in plastic formats.

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References

[1] Pfizer. "ZOSYN (piperacillin and tazobactam) Product Monograph."
[2] FDA. "Guidance for Industry: Labeling of Injectable Drugs."
[3] MarketsandMarkets. "Antibiotics Market by Type and Region."
[4] IQVIA. "Global Hospital and Healthcare Market Trends." [5] Roche. "Innovations in Pharmaceutical Packaging: Safety and Operational Benefits."