Piperacillin sodium; tazobactam sodium - Generic Drug Details

What are the generic sources for piperacillin sodium; tazobactam sodium and what is the scope of freedom to operate?

Piperacillin sodium; tazobactam sodium is the generic ingredient in four branded drugs marketed by Astral, Eugia Pharma, Eugia Pharma Speclts, Fresenius Kabi, Fresenius Kabi Usa, Hospira Inc, Istituto Bio Ita Spa, Milla Pharms, Onesource Specialty, Sagent Pharms Inc, Sandoz, Shandong, Wockhardt Bio Ag, Wyeth Pharms, Baxter Hlthcare Corp, and B Braun Medical, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

Eighteen suppliers are listed for this compound.

Summary for piperacillin sodium; tazobactam sodium

US Patents:	0
Tradenames:	4
Applicants:	16
NDAs:	25
Finished Product Suppliers / Packagers:	18
Clinical Trials:	5
DailyMed Link:	piperacillin sodium; tazobactam sodium at DailyMed

Recent Clinical Trials for piperacillin sodium; tazobactam sodium

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 2
St. Justine's Hospital	Phase 1
Phillip Brian Smith	Phase 1

See all piperacillin sodium; tazobactam sodium clinical trials

Pharmacology for piperacillin sodium; tazobactam sodium

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

Anatomical Therapeutic Chemical (ATC) Classes for piperacillin sodium; tazobactam sodium

J01CA	Penicillins with extended spectrum
J01C	BETA-LACTAM ANTIBACTERIALS, PENICILLINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J01CG	Beta-lactamase inhibitors
J01C	BETA-LACTAM ANTIBACTERIALS, PENICILLINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

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 piperacillin sodium; tazobactam sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Istituto Bio Ita Spa	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	065523-003	May 31, 2011	AP	RX	No	No
Sandoz	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	065363-001	Oct 21, 2010	AP	RX	No	No
Sagent Pharms Inc	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	208674-001	Feb 16, 2021	AP	RX	No	No
Wockhardt Bio Ag	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	207146-001	Mar 17, 2017	AP	RX	No	Yes
Hospira Inc	PIPERACILLIN AND TAZOBACTAM	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	065446-001	Sep 15, 2009		DISCN	No	No

Expired US Patents for piperacillin sodium; tazobactam sodium

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	050750-001	Feb 24, 1998
Wyeth Pharms	ZOSYN	piperacillin sodium; tazobactam sodium	INJECTABLE;INJECTION	050684-003	Oct 22, 1993
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

Market Dynamics and Financial Trajectory for Piperacillin Sodium; Tazobactam Sodium

Last updated: July 30, 2025

---

Introduction

Piperacillin sodium combined with tazobactam sodium, commonly known as Zosyn®, represents a broad-spectrum beta-lactam/beta-lactamase inhibitor combination approved for various serious bacterial infections. The drug’s pharmacological profile and clinical utility have positioned it as a critical component in hospital-based antimicrobial therapy. This report examines the current market dynamics, competitive landscape, regulatory factors, and the financial trajectory influencing the commercial ecosystem surrounding piperacillin-tazobactam.

---

Market Overview and Size

The global antibiotic market is anticipated to reach USD 50 billion by 2028, with hospital-acquired infections (HAIs), pneumonia, intra-abdominal infections, and skin infections driven predominantly by multidrug-resistant organisms fueling demand for broad-spectrum agents like piperacillin-tazobactam [1]. The drug's pivotal role in treating severe infections lends stability to its revenue streams, particularly in developed healthcare markets.

Analyzing current sales data, piperacillin-tazobactam generates approximately USD 1.8-2 billion annually across North America, Europe, and select Asia-Pacific regions. The growth rate is estimated at 3-5% CAGR, driven by antimicrobial resistance (AMR) trends and hospital protocols emphasizing empiric therapy replacement with broad-spectrum antibiotics [2].

---

Market Drivers

Antimicrobial Resistance (AMR) and Clinical Utility

The escalating prevalence of multidrug-resistant bacteria, notably Pseudomonas aeruginosa, Escherichia coli, and Klebsiella pneumoniae, sustains demand for piperacillin-tazobactam [3]. Its combination effectively inhibits beta-lactamase enzymes, restoring activity against resistant strains, which durably positions it as a preferred empiric choice in severe infections.

Hospital Infections and Expanding Indications

Growth in hospital-acquired pneumonia, intra-abdominal infections, and complicated urinary tract infections amplifies the drug's usage. The rise in immunocompromised patient populations, aging demographics, and complex surgeries further underpin demand trajectories.

Regulatory Approvals and New Formulations

Regulatory agencies, including the FDA and EMA, continue to authorize additional indications, while pipeline enhancements such as fixed-dose combinations and injectable formulations boost competitive positioning.

---

Market Challenges

Antimicrobial Stewardship Policies

Stringent antimicrobial stewardship programs globally aim to reduce unnecessary broad-spectrum antibiotic use, potentially limiting piperacillin-tazobactam prescriptions. This measure, while critical for resistance management, risks constraining short-term revenue growth.

Generic Competition and Pricing Pressures

Most formulations are off-patent, leading to intense price competition among generic manufacturers. Market commoditization pressures margins downward, especially in regions with aggressive pricing policies [4].

Emergence of Resistance

Though effective, resistance to piperacillin-tazobactam is increasingly reported, notably in ESBL-producing organisms. The potential for future resistance threatens long-term clinical utility and revenue streams.

---

Competitive Landscape

Major pharmaceutical companies such as Pfizer (Zosyn®) dominate the market, certified through extensive clinical data and established hospital formulary positions. Generic companies—Teva, Sandoz, Mylan—have expanded access, offering lower-cost options that erode branded sales margins.

Emerging alternatives, including cephalosporin/beta-lactamase inhibitor combinations and carbapenems, are vying for market share, especially as resistance evolves. Novel agents like relebactam and avibactam combinations expand the therapeutic landscape but currently operate at premium pricing levels with limited adoption.

---

Regulatory and Patent Landscape

Pfizer holds the primary patent rights for Zosyn® in various jurisdictions, though many have expired or are close to expiry, enabling increased generic competition. Regulatory authorities underscore the importance of stewardship, but approval pathways remain receptive to new formulations or combination extensions, promising future pipeline opportunities.

---

Financial Trajectory and Future Outlook

Despite generic erosion, the baseline revenue for piperacillin-tazobactam remains resilient due to critical hospital use. The insured hospital segment accounts for over 70% of sales, with an expected CAGR of 2-4%, reflecting ongoing demand driven by resistant infections and expanding indications.

Innovations such as inhaled formulations for cystic fibrosis or new combination therapies that circumvent resistance could provide upward revenue inflections. Conversely, intensified stewardship policies and resistance evolution pose risks to long-term profitability.

Overall, the financial outlook remains cautiously optimistic, with sustained demand in established markets and emerging opportunities in infection control and special indications.

---

Key Market Opportunities

• Developing regions exhibit growth potential, fueled by expanding healthcare infrastructure and rising resistance.
• Combination therapy innovations or scheduled patent extensions could mitigate generic pricing pressures.
• Precision medicine and diagnostics improving targeted therapy placement may bolster piperacillin-tazobactam utilization.

---

Conclusion

The market dynamics for piperacillin sodium; tazobactam sodium are characterized by strong clinical need, resilient sales bolstered by resistance challenges, and competitive pressures from generics. While current revenue streams are stable, future growth hinges on combating resistance, innovation, and policy alignment with stewardship initiatives.

---

Key Takeaways

• Demand stability stems from their essential role in treating severe and resistant bacterial infections.
• Generic competition is intensifying, necessitating strategic differentiation through formulations and indications.
• Antimicrobial stewardship policies may temper growth but are critical for long-term sustainability.
• Investments in pipeline innovations and resistant pathogen management remain crucial for future profitability.
• Emerging markets present notable growth opportunities due to increasing healthcare infrastructure and infection prevalence.

---

FAQs

Q1: How does antimicrobial resistance impact the market for piperacillin-tazobactam?
A: Rising resistance diminishes clinical efficacy, prompting stewardship programs that restrict broad-spectrum antibiotic use, which could limit sales but also incentivize innovation and combination strategies to maintain relevance.

Q2: What are the main competitors to piperacillin-tazobactam?
A: Alternatives include newer beta-lactam/beta-lactamase inhibitors like avibactam-based agents, cephalosporins with similar properties, and carbapenems, though these often come at higher costs or resistance challenges.

Q3: How significant is the impact of patent expirations on the market?
A: Patent expirations facilitate generic entry, increasing affordability but reducing margins for branded manufacturers; this pressure necessitates diversification and innovation to sustain revenue.

Q4: Are there promising pipeline developments for piperacillin-tazobactam?
A: While new formulations and combination therapies are under investigation, widespread adoption depends on overcoming regulatory, resistance, and pricing hurdles.

Q5: What role do emerging markets play in the future of piperacillin-tazobactam sales?
A: Growing healthcare infrastructure and disease burden in emerging markets offer substantial growth potential; however, pricing sensitivities and stewardship policies influence market penetration.

---

References

[1] Grand View Research, "Antibiotics Market Size & Trends," 2022.
[2] IQVIA, "Global Antibiotic Sales Data," 2022.
[3] CDC, "Antimicrobial Resistance Threats Report," 2020.
[4] EvaluatePharma, "Generic Drug Market Trends," 2022.