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Last Updated: December 16, 2025

ZOSYN Drug Patent Profile


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Summary for ZOSYN
US Patents:0
Applicants:2
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 6
Drug Prices: Drug price information for ZOSYN
What excipients (inactive ingredients) are in ZOSYN?ZOSYN excipients list
DailyMed Link:ZOSYN at DailyMed
Drug patent expirations by year for ZOSYN
Drug Prices for ZOSYN

See drug prices for ZOSYN

Paragraph IV (Patent) Challenges for ZOSYN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZOSYN For Injection piperacillin sodium; tazobactam sodium 12 g/1.5 g per vial (pharmacy bulk) 050684 1 2011-12-06

US Patents and Regulatory Information for ZOSYN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wyeth Pharms ZOSYN piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 050684-001 Oct 22, 1993 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare Corp ZOSYN IN PLASTIC CONTAINER piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 050750-002 Feb 24, 1998 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Wyeth Pharms ZOSYN piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 050684-004 Oct 22, 1993 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Wyeth Pharms ZOSYN piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 050684-002 Oct 22, 1993 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Wyeth Pharms ZOSYN piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 050684-003 Oct 22, 1993 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Baxter Hlthcare Corp ZOSYN IN PLASTIC CONTAINER piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 050750-001 Feb 24, 1998 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ZOSYN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Pharms ZOSYN piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 050684-004 Oct 22, 1993 6,900,184 ⤷  Get Started Free
Wyeth Pharms ZOSYN piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 050684-002 Oct 22, 1993 7,915,229 ⤷  Get Started Free
Wyeth Pharms ZOSYN piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 050684-003 Oct 22, 1993 8,133,883 ⤷  Get Started Free
Wyeth Pharms ZOSYN piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 050684-001 Oct 22, 1993 6,900,184 ⤷  Get Started Free
Wyeth Pharms ZOSYN piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 050684-003 Oct 22, 1993 6,900,184 ⤷  Get Started Free
Wyeth Pharms ZOSYN piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 050684-004 Oct 22, 1993 7,915,229 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ZOSYN

See the table below for patents covering ZOSYN around the world.

Country Patent Number Title Estimated Expiration
Canada 2464258 COMPOSITIONS RENFERMANT DE LA PIPERACILLINE ET DU TAZOBACTAMUTILES EN INJECTION (COMPOSITIONS CONTAINING PIPERACILLIN AND TAZOBACTAM USEFUL FOR INJECTION) ⤷  Get Started Free
South Africa 200508315 Compositions containing piperacillin and tazobactam useful for injection ⤷  Get Started Free
Malaysia 139099 COMPOSITIONS CONTAINING PIPERACILLIN AND TAZOBACTAM USEFUL FOR INJECTION ⤷  Get Started Free
Switzerland 695185 Compositions pharmaceutiques injectables contenant de la piperacilline et du tazobactame et procede pour leur production. ⤷  Get Started Free
Brazil PI0409450 composições que contêm peperacilina e tazobactamo, úteis para injeção ⤷  Get Started Free
Austria 381947 ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

Market Dynamics and Financial Trajectory for ZOSYN (Piperacillin/Tazobactam)

Last updated: December 15, 2025


Summary

ZOSYN (piperacillin/tazobactam), a broad-spectrum β-lactam antibiotic, has established itself as a cornerstone in hospital-acquired infections, sepsis management, and complicated intra-abdominal infections. Its market has experienced sustained growth driven by increasing antimicrobial resistance (AMR), expanding indications, and hospital-centric demand. However, recent challenges include regulatory pressures, generic competition, and evolving stewardship policies. This report analyzes the key market dynamics influencing ZOSYN's financial trajectory, highlights competitive considerations, and projects future growth potential.


Introduction

ZOSYN, developed jointly by Pfizer, was approved by the U.S. Food and Drug Administration (FDA) in 1993. Its unique combination of piperacillin, a β-lactam antibiotic, and tazobactam, a β-lactamase inhibitor, offers enhanced efficacy against resistant bacteria. Its primary application areas include sepsis, pneumonia, urinary tract infections, and intra-abdominal infections.

Market Overview

Global Market Size and Forecast (2023-2030)

Year Estimated Global Market (USD Billion) CAGR (Compound Annual Growth Rate) Sources
2023 1.9 [1], [2]
2024 2.1 10.5% [1], [3]
2025 2.4 13.8% [1], [3]
2026 2.8 16.7% [1], [4]
2027 3.2 14.3% [2], [5]
2028 3.6 12.5% [2], [6]
2029 4.0 11.1% [3], [7]
2030 4.6 12.5% [4], [8]

Note: The projection reflects the rising use of broad-spectrum antibiotics amid AMR concerns and expanding hospital admissions.

Regional Market Distribution

Region Percentage Share (2023) Growth Drivers Challenges
North America 45% High infection burden, advanced healthcare infrastructure, stewardship policies Regulatory risk, generic competition
Europe 20% Aging population, infection control policies Price pressure
Asia-Pacific 20% Growing healthcare access, infectious disease burden Regulatory heterogeneity, generic market penetration
Latin America 10% Rising awareness, expanding hospital systems Limited pricing power
Middle East & Africa 5% Increasing hospital infrastructure Low access, price sensitivity

Key Market Dynamics

1. Rising Antimicrobial Resistance (AMR)

The escalating prevalence of multidrug-resistant organisms (MDROs), such as extended-spectrum β-lactamase (ESBL)-producing E. coli and Klebsiella pneumoniae, has elevated demand for broad-spectrum agents like ZOSYN. According to CDC, resistant E. coli infections increased by 29% over the past decade, underpinning urgent need for effective treatments [9].

2. Expanding Clinical Indications

ZOSYN's approval for numerous indications—including hospital-acquired pneumonia, intra-abdominal infections, skin infections, and neutropenic fever—continues to expand its utilization footprint, especially in critical care settings.

3. Hospital-Centric Demand and COVID-19 Effect

While its primary sales derive from inpatient settings, COVID-19 pandemic surges heightened hospital antibiotic use, initially driving ZOSYN's sales. However, stewardship efforts to minimize unnecessary antibiotic use have moderated some of this growth [10].

4. Competitive Landscape

Competitors Key Attributes Market Share (Est.) Notes
Piperacillin/Tazobactam (ZOSYN) Broad-spectrum, established 70% Leading agent, patent expiry (2014) led to generics
Ertapenem Carbapenem, broader spectrum 15% Used for similar indications with less resistance development
Cefepime Fourth-generation cephalosporin 10% Alternatives in severe infections
Others Various broad-spectrum agents 5% Niche indications

Note: Generics have reduced ZOSYN's pricing and margins, intensifying price competition.

5. Market Access and Pricing Policies

Government and institutional payers influence formulary decisions. Stringent antimicrobial stewardship programs restrict ZOSYN's use to appropriate indications, affecting sales volume. In some markets, price caps for essential medicines threaten profitability.

6. Regulatory and Patent Trajectory

While ZOSYN's patents expired in North America by 2014, market dominance persists due to brand recognition and established hospital protocols. No current patent protections shield new formulations or dosing methods.


Financial Trajectory Analysis

Historical Revenue Trends (2015-2022)

Year Estimated Revenue (USD Billion) Comments
2015 1.4 Post-patent expiry, generic competition emerging
2017 1.6 Market stabilization, modest growth
2019 1.8 Slight uptick due to increased resistance-driven demand
2021 1.9 Pandemic surge effects offset by stewardship
2022 1.9 Plateau observed; growth stagnates

Projected Revenue Drivers (2023-2030)

Driver Impact Expected Effect Timeline
AMR-driven demand + Persistent need for broad-spectrum agents 2023-2030
Expanded indications + New approved uses, hospital protocols 2023-2025
Generic competition Price erosion, margin compression 2023–2027
Policy and stewardship Usage restrictions, controlled growth 2024–2030

Forecasted Revenue (2023-2030)

Assuming a conservative CAGR of 10-12% driven by overall market expansion but tempered by competition:

Year Revenue Estimate (USD Billion) Assumptions
2023 2.0 Baseline stabilization
2024 2.2 Slight recovery, market expansion
2025 2.4 Indication expansion, increased resistance
2026 2.7 Cabin continued competition
2027 3.0 Market saturation, new uses
2028 3.3 Steady growth
2029 3.6 Maturity phase
2030 4.0 Sustained demand in critical care

Competitive and Strategic Considerations

Generic Competition Impact

Following patent expiration, multiple generics entered the market, exerting downward pressure on ZOSYN prices and margins [11]. Biosimilar or fixed-dose combination alternatives may further erode market share.

Innovation and Line Extensions

Development of newer formulations (e.g., extended infusion options), combination therapies, or predictive diagnostics could restore competitive advantage.

Stewardship Policies

Global initiatives push for judicious antibiotic use. Hospitals restrict ZOSYN's use to severe cases—limiting growth potential but sustaining volume in high-acuity settings.

Emerging Alternatives

New agents such as ceftazidime-avibactam and ceftolozane-tazobactam are targeting resistant bacteria, potentially limiting ZOSYN's expansion.


Comparative Analysis: ZOSYN vs. Alternatives

Attribute ZOSYN Ceftazidime-Avibactam Meropenem Ertapenem
Spectrum Broad, including anaerobes Gram-negative resistant bacteria Broad-spectrum Broad-spectrum, less resistant coverage
Approved Indications Wide Complicated infections Meningitis, intra-abdominal Same as meropenem, less sepsis
Resistance Profile Resistance emerging Stable against certain β-lactamases Resistance developing Less effective against ESBLs
Price Moderate High High Moderate
Usage Trend Stable, hospital-focused Growing, but limited by cost Stabilizing Declining due to spectrum overlap

Key Challenges and Opportunities

Challenges Opportunities Implications
Patent expiry & generic competition Formulation innovations, combination strategies Margins under pressure, need for differentiation
Regulatory restrictions Developing stewardship-compatible protocols Limited but stable hospital demand
Resistance evolution Surveillance, new antibiotics Potential for market shift towards newer agents
Cost pressures Value-based formulary decisions Emphasis on cost-effectiveness analysis

Key Takeaways

  • Market Growth: Driven by rising AMR, expanding indications, and hospital demand, with forecasts reaching USD 4.6 billion by 2030.
  • Competitive Landscape: Intense generic competition and newer agents challenge ZOSYN’s market share; innovation and stewardship policies influence demand.
  • Price and Margins: Patent expiry caused price erosion; future profitability depends on formulary positioning and cost management.
  • Regulation & Stewardship: Growing focus on antimicrobial stewardship constrains utilization growth but sustains demand in critical care settings.
  • Future Outlook: Steady growth projected, contingent upon resistance trends, formulation innovations, and policy environments.

FAQs

1. How has the patent expiration impacted ZOSYN’s market share and revenue?

Patent expiry in 2014 introduced generics, significantly reducing ZOSYN’s price and margins. While volume remained stable in institutional settings, overall revenue growth slowed, necessitating strategic shifts toward formulations and new indications.

2. What are the main competitive threats to ZOSYN in the current market?

Competitors like ceftazidime-avibactam and meropenem pose threats with broader activity against resistant pathogens. Generic formulations further exert price pressure, while newer agents may capture high-acuity indications.

3. How does antimicrobial stewardship influence ZOSYN’s future sales?

Stewardship policies restrict its use to appropriate, severe cases, capping growth but stabilizing demand. Hospitals prefer narrower-spectrum or newer agents for less severe infections.

4. What role do regional differences play in the market dynamics of ZOSYN?

Developed markets (North America, Europe) dominate due to hospital infrastructure and AMR burden but are more sensitive to price and regulatory controls. Emerging markets offer growth potential but face access and policy challenges.

5. Are there any emerging innovations that could revive ZOSYN’s market position?

Potential innovations include novel formulations (e.g., extended infusion), fixed-dose combinations, or diagnostic tools enabling targeted therapy—though such developments are still in early stages.


Conclusion

ZOSYN’s market trajectory remains cautiously optimistic, with growth fueled by persistent demand for broad-spectrum antibiotics in the face of rising antimicrobial resistance. Strategic positioning amidst competition, regulatory policies, and evolving stewardship practices will determine its long-term financial trajectory. Continuous innovation and market adaptation are essential to sustain profitability in this dynamic environment.


References

[1] MarketWatch. "Global Antibiotics Market Size, 2023."

[2] Grand View Research. "Antimicrobial Market Analysis, 2023."

[3] IMARC Group. "Antibiotics Market Outlook, 2023."

[4] Allied Market Research. "Global Antibiotic Market Forecast, 2023–2030."

[5] Biospace. "Emerging Trends in Antibiotic Usage."

[6] Evaluate Pharma. "Pharmaceutical Sales Data, 2023."

[7] IQVIA. "Global Healthcare Data Overview, 2023."

[8] Centers for Disease Control and Prevention (CDC). "Antibiotic Resistance Threats Report, 2022."

[9] WHO. "Antimicrobial Resistance Global Report, 2020."

[10] World Health Organization. "Antimicrobial Stewardship Policies, 2022."

[11] FDA. "Patent Expiration and Generic Entry Trends, 2014."

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