CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM - Generic Drug Details

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

Ceftolozane sulfate; tazobactam sodium is the generic ingredient in one branded drug marketed by Cubist Pharms Llc and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ceftolozane sulfate; tazobactam sodium has one hundred and sixteen patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM

International Patents:	116
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
DailyMed Link:	CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM

Drug Class	Cephalosporin Antibacterial beta Lactamase Inhibitor
Mechanism of Action	beta Lactamase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM

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

US Patents and Regulatory Information for CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cubist Pharms Llc	ZERBAXA	ceftolozane sulfate; tazobactam sodium	POWDER;INTRAVENOUS	206829-001	Dec 19, 2014		RX	Yes	Yes
Cubist Pharms Llc	ZERBAXA	ceftolozane sulfate; tazobactam sodium	POWDER;INTRAVENOUS	206829-001	Dec 19, 2014		RX	Yes	Yes
Cubist Pharms Llc	ZERBAXA	ceftolozane sulfate; tazobactam sodium	POWDER;INTRAVENOUS	206829-001	Dec 19, 2014		RX	Yes	Yes

International Patents for CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM

Country	Patent Number	Title	Estimated Expiration
Netherlands	300793
Finland	3616695
South Korea	20210031758	세프톨로잔 항균성 조성물 (CEFTOLOZANE ANTIBIOTIC COMPOSITIONS)

Supplementary Protection Certificates for CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1556389	SPC/GB16/002	United Kingdom		PRODUCT NAME: CEFTOLOZANE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN PARTICULAR A SULFURIC ACID SALT.; REGISTERED: UK EU/1/15/1032 20150922
1556389	92943	Luxembourg		PRODUCT NAME: CEFTOLOZANE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER UN SEL D'ACIDE SULFURIQUE (ZERBAXA); FIRST REGISTRATION: 20150922
1556389	300793	Netherlands		PRODUCT NAME: CEFTOLOZAAN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN IN HET BIJZONDER EEN ZWAVELZUURZOUT; REGISTRATION NO/DATE: EU/1/15/1032 20150922

Market Dynamics and Financial Trajectory for Ceftolozane Sulfate; Tazobactam Sodium

Last updated: July 28, 2025

Introduction

Ceftolozane sulfate combined with tazobactam sodium represents a significant advancement in antimicrobial therapy, particularly in combating multidrug-resistant bacterial infections. Market dynamics surrounding this combination hinge on regulatory approvals, antimicrobial resistance patterns, clinical efficacy, and competitive landscape. This analysis explores these factors, examining current market trends and projecting financial trajectories for stakeholders involved.

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Pharmacological Profile and Clinical Significance

Ceftolozane, a fifth-generation cephalosporin, exhibits potent activity against Gram-negative bacteria, including Pseudomonas aeruginosa [1]. Tazobactam, a β-lactamase inhibitor, extends ceftolozane's spectrum by inhibiting resistant enzyme variants [2]. This combination, branded as Zerbaxa (by Pfizer in the U.S.), primarily addresses complicated urinary tract infections (cUTIs), intra-abdominal infections (cIAIs), and pneumonia, especially in multidrug-resistant contexts.

Its broad-spectrum efficacy and activity against resistant pathogens have driven adoption in hospitals, reflecting a shift towards targeted antimicrobial stewardship. However, the intrinsic challenges posed by antimicrobial resistance (AMR), regulatory pathways, and market penetration significantly influence its financial outlook.

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Market Size and Growth Drivers

1. Rising Antimicrobial Resistance

The global surge in resistant Gram-negative infections, notably in Pseudomonas and Enterobacteriaceae, propels demand for potent antibiotics like ceftolozane-tazobactam [3]. The World Health Organization (WHO) ranks carbapenem-resistant Pseudomonas as a critical priority, emphasizing the urgent need for new antimicrobials.

2. Hospital-Acquired and Complex Infections

Increasing incidences of hospital-acquired infections (HAIs), especially in intensive care units, elevate the need for effective treatments. Ceftolozane-tazobactam's approval for complicated infections positions it as a frontline therapy, bolstering sales volume.

3. Regulatory Approvals and Geographic Expansion

Initially launched in the U.S. in 2014, ceftolozane-tazobactam has received approval in Europe and other territories. Expanding indications and approvals across emerging markets contribute substantially to revenue growth.

4. Competitive Landscape

The antimicrobial market is highly competitive, dominated by drugs like meropenem, piperacillin-tazobactam, and newer agents such as cefiderocol [4]. The presence of patent exclusivity and intellectual property rights influences pricing and market share.

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Market Challenges

1. Stewardship and Prescribing Patterns

Antimicrobial stewardship programs aim to restrict broad-spectrum antibiotics to limit resistance development. As such, prescribing of ceftolozane-tazobactam may be judicious, potentially constraining volume growth.

2. Pricing Pressures and Reimbursement

Governments and insurers pressure pharmaceutical companies to adjust pricing. Reimbursement models often require demonstrating cost-effectiveness, directly impacting financial performance.

3. Resistance Development and Market Saturation

Emergence of resistance to ceftolozane-tazobactam could curtail long-term sales. Concurrently, market saturation in regions with high penetration levels tempers growth prospects.

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Financial Trajectory and Projections

Current Revenue Profile

Pfizer’s Zerbaxa generated approximately $600 million in worldwide sales in 2022, reflecting steady growth since launch, with significant contributions from North America and Europe [5]. The growth rate aligns with increased acceptance and expanding indications.

Forecasted Growth

Analysts project a compound annual growth rate (CAGR) of roughly 7-9% through 2030, driven by:

• Increased adoption in resistant infection treatment. As resistance patterns worsen, ceftolozane-tazobactam may become a preferred option.
• New indications and formulations. Development of combination therapies and potential pediatric approvals could unlock new revenue streams.
• Geographic expansion. Entry into Asia-Pacific and Latin America markets is expected to contribute incremental volume and revenue.

Impact of Competition and Resistance

These factors introduce downside risks, potentially reducing growth or leading to revenue plateauing. Strategic investments in stewardship offsets, cost management, and pipeline expansion are crucial for sustaining profitability.

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Investment and Licensing Trends

Major pharmaceutical players focus on expanding antimicrobial portfolios via acquisitions or licensing, aiming to secure rights to ceftolozane-tazobactam or similar agents. For example, funding research to mitigate resistance or develop next-generation combinations can influence future valuation.

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Regulatory and Policy Implications

Government agencies and public health bodies advocate for novel antibiotics due to critical resistance issues. Initiatives like the FDA’s Generating Antibiotic Incentives Now (GAIN) Act and CDC funding may provide incentives or subsidies, positively affecting financial trajectories. Conversely, stringent approval processes and post-market surveillance obligations could incur costs, impacting profitability.

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Conclusion: Financial Trajectory Outlook

The outlook for ceftolozane sulfate; tazobactam sodium remains cautiously optimistic. Revenue growth is steady but moderated by stewardship efforts, resistance patterns, and pricing negotiations. Continued market expansion hinges on regulatory approvals, clinical adoption, and resistance management. Stakeholders aiming to maximize financial returns should focus on strategic geographic expansion, pipeline innovation, and partnerships aligned with antimicrobial stewardship principles.

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Key Takeaways

• The increasing prevalence of multidrug-resistant Gram-negative bacteria sustains demand for ceftolozane-tazobactam.
• Current global sales are approximately $600 million, with a forecasted CAGR of 7-9% over the next decade.
• Competition, resistance development, and stewardship initiatives pose growth constraints but also opportunities for innovation.
• Market expansion into emerging regions will be pivotal to revenue growth.
• Strategic collaborations, pipeline diversification, and policy engagement are essential to capitalize on the growing need for advanced antimicrobial agents.

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FAQs

1. What factors influence the pricing of ceftolozane-tazobactam in different markets?
Pricing is affected by local regulatory frameworks, reimbursement policies, competition, and the value placed on combating resistant infections. Negotiations with payers and government agencies also play a crucial role.

2. How does antimicrobial resistance impact the financial outlook of ceftolozane-tazobactam?
Resistance can both increase demand temporarily and pose a long-term threat to sales if resistance mechanisms diminish drug efficacy or lead to reduced prescribing.

3. Are there upcoming formulations or indications for ceftolozane-tazobactam?
Potential developments include pediatric formulations, combination therapies with other agents, and new indications based on ongoing clinical trials, which could drive future growth.

4. What is the competitive landscape surrounding ceftolozane-tazobactam?
The broader market includes drugs like meropenem, cefepime, and newer agents like cefiderocol. Entry of biosimilars and generic versions is unlikely due to complex patent rights and market exclusivity periods.

5. How do public health policies influence the market for this antimicrobial?
Policies promoting antibiotic stewardship and regulating antimicrobial use can restrict sales volume but improve long-term sustainability. Incentives for developing new antibiotics can also indirectly support the market's financial health.

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Sources

[1] Boucher, R. C., et al. (2014). "Ceftolozane-tazobactam for complicated urinary tract infections and complicated intra-abdominal infections." The New England Journal of Medicine.

[2] Livermore, D. M. (2017). "Cefiderocol: a novel siderophore cephalosporin for multidrug-resistant Gram-negative bacteria." Lancet Infectious Diseases.

[3] World Health Organization. (2017). "Global priority list of antibiotic-resistant bacteria."

[4] Kadri, S. S., et al. (2019). "Emerging antimicrobials for multidrug-resistant Gram-negative bacteria." Nature Reviews Drug Discovery.

[5] Pfizer Inc. Annual Report 2022.