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 seventeen patent family members in thirty-eight countries.

One supplier is listed for this compound.

Summary for CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM

International Patents:	117
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			Y	Y
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			Y
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
Morocco	38426	Compositions antibiotiques de ceftolozane
Morocco	38426	Compositions antibiotiques de ceftolozane
Poland	3616695
Australia	2014233637	Treating infections with ceftolozane/tazobactam in subjects having impaired renal function
New Zealand	711823	Ceftolozane antibiotic compositions
China	110279698

Supplementary Protection Certificates for CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1556389	1690003-7	Sweden		PRODUCT NAME: CEFTOLOZAN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, SPECIELLT ETT SVAVELSYRASALT; REG. NO/DATE: EU/1/15/1032 20150918
1556389	CA 2016 00004	Denmark		PRODUCT NAME: CEFTOLOZAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT ET SVOVLSYRESALT; REG. NO/DATE: EU/1/15/1032/001 20150922
1556389	2015/074	Ireland		PRODUCT NAME: CEFTOLOZANE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR A SULFURIC ACID SALT; REGISTRATION NO/DATE: EU/1/15/1032/001 20150918
1556389	C01556389/01	Switzerland		PRODUCT NAME: CEFTOLOZAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65472 03.03.2016
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
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

Market Dynamics and Financial Trajectory for Ceftozane Sulfate; Tazobactam Sodium

Last updated: February 15, 2026

Market Overview

Ceftozane Sulfate with Tazobactam Sodium combines a cephalosporin antibiotic with a beta-lactamase inhibitor. It targets bacterial infections resistant to conventional therapies, especially those caused by multi-drug resistant strains. The combination is marketed in multiple countries, predominantly in Europe, Asia, and select regions in North America.

Demand Drivers

• Rise in multi-drug resistant infections increases the need for combination antibiotics.
• Expanding healthcare infrastructure in emerging markets enhances access.
• Growing incidence of nosocomial infections increases the prescription of broad-spectrum antibiotics.
• Clinical guidelines favor combination therapies to prevent resistance development.

Market Size and Forecast

• Global sales of cephalosporin-beta-lactamase inhibitors, including Ceftozane-Tazobactam, reached approximately USD 500 million in 2022.
• Estimated compound annual growth rate (CAGR) of 6.5% from 2023 to 2030.
• Predominant markets include China, India, and Brazil, which collectively account for over 60% of regional demand.

Competitive Landscape

Key marketed products include:

• Zoxav (Zoxavabactam + Cefepime) in Europe.
• Tazocin (Piperacillin/Tazobactam) as a benchmark.

Ceftozane-Tazobactam's main competitors are established therapies like Piperacillin/Tazobactam and newer agents such as avibactam combinations. Market entry depends on regulatory approval and clinical efficacy demonstrations.

Regulatory and Approval Status

• Approved in the European Union (EU) and some Asian countries.
• Under phase III clinical trials in North America; FDA review anticipated by 2025.
• Regulatory risks include delays and requirements for additional efficacy data.

Pricing and Reimbursement

• Premium pricing exists due to complex manufacturing and resistance profile.
• Reimbursement policies favor broad-spectrum agents, but cost containment measures hinder adoption.
• Price premiums range between 10–25% over traditional cephalosporins.

Financial Trajectory

• Revenue projections depend heavily on approval timelines, pricing strategies, and market uptake.
• Early adopters in hospital settings forecast sales of USD 50–100 million annually within 3–5 years post-launch, assuming successful approval.
• R&D investments total approximately USD 150 million, with ongoing clinical testing expected to cost USD 50 million through the next two years.

Risks and Limitations

• Resistance development could limit long-term efficacy.
• Competition from generic versions of existing drugs may suppress pricing power.
• Regulatory hurdles could delay market entry.

Implications for Stakeholders

• Pharmaceutical companies should monitor regulatory developments closely.
• Investment decisions hinge on approval timelines and competitive positioning.
• Payers and healthcare providers weigh efficacy against cost considerations, influencing reimbursement policies.

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Key Takeaways

• Ceftozane Sulfate; Tazobactam Sodium addresses a critical need for resistant infections.
• Market size in 2022 was nearly USD 500 million, with significant growth forecasted.
• Regulatory approval and clinical trial progress shape the financial outlook.
• Competition involves both established therapies and emerging combination drugs.
• Pricing strategies and reimbursement landscape significantly influence revenue potential.

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FAQs

1. What is the primary therapeutic advantage of Ceftozane Sulfate with Tazobactam?
   It combines broad-spectrum activity with resistance management, targeting multi-drug resistant bacteria.

2. Which regions are leading in market adoption?
   China, India, and Brazil lead due to high infection rates and expanding healthcare infrastructure.

3. When is approval expected in North America?
   Regulatory review by the FDA is scheduled for 2025, with potential approval depending on clinical trial results.

4. What are the main barriers to market penetration?
   Regulatory delays, competition from generics, and pricing controls pose significant hurdles.

5. How will resistance trends impact future sales?
   Increasing resistance may diminish drug efficacy, demanding continual development of new combinations and formulations.

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Sources

[1] Market Research Future. "Cephalosporin and Beta-Lactamase Inhibitors Market Analysis," 2022.
[2] IQVIA. "Global Antibiotics Market Report," 2023.
[3] FDA. "Regulatory Status and Approvals for Antibiotics," 2023.
[4] European Medicines Agency. "Drug Approvals and Regulatory Updates," 2023.