ZERBAXA Drug Patent Profile

Which patents cover Zerbaxa, and when can generic versions of Zerbaxa launch?

Zerbaxa is a drug marketed by Cubist Pharms Llc and is included in one NDA. There are twelve patents protecting this drug.

This drug has one hundred and seventeen patent family members in thirty-eight countries.

The generic ingredient in ZERBAXA is ceftolozane sulfate; tazobactam sodium. One supplier is listed for this compound. Additional details are available on the ceftolozane sulfate; tazobactam sodium profile page.

DrugPatentWatch^® Generic Entry Outlook for Zerbaxa

Zerbaxa was eligible for patent challenges on December 19, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 14, 2035. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ZERBAXA

International Patents:	117
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	6
Drug Prices:	Drug price information for ZERBAXA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZERBAXA
What excipients (inactive ingredients) are in ZERBAXA?	ZERBAXA excipients list
DailyMed Link:	ZERBAXA at DailyMed

See drug prices for ZERBAXA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ZERBAXA

Constraining patent/regulatory exclusivity:

10,125,149

NDA:

206829

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.

Recent Clinical Trials for ZERBAXA

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

Sponsor	Phase
Hamad Medical Corporation	Phase 4
University Hospital, Toulouse	Phase 3
The University of Queensland	Phase 1/Phase 2

See all ZERBAXA clinical trials

Pharmacology for ZERBAXA

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

US Patents and Regulatory Information for ZERBAXA

ZERBAXA is protected by twenty-six US patents.

This potential generic entry date is based on patent 10,125,149.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	7,129,232		Y	Y
Cubist Pharms Llc	ZERBAXA	ceftolozane sulfate; tazobactam sodium	POWDER;INTRAVENOUS	206829-001	Dec 19, 2014		RX	Yes	Yes	8,906,898		Y	Y
Cubist Pharms Llc	ZERBAXA	ceftolozane sulfate; tazobactam sodium	POWDER;INTRAVENOUS	206829-001	Dec 19, 2014		RX	Yes	Yes	10,376,496
Cubist Pharms Llc	ZERBAXA	ceftolozane sulfate; tazobactam sodium	POWDER;INTRAVENOUS	206829-001	Dec 19, 2014		RX	Yes	Yes	9,724,353

International Patents for ZERBAXA

When does loss-of-exclusivity occur for ZERBAXA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

China

European Patent Office

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ZERBAXA around the world.

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

Supplementary Protection Certificates for ZERBAXA

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

Market Dynamics and Financial Trajectory for ZERBAXA

Last updated: March 14, 2026

ZERBAXA (imipenem/cilastatin/relebactam) is an FDA-approved combination antibiotic for complicated infections, including intra-abdominal infections, urinary tract infections, and certain pneumonia. Since its launch, ZERBAXA has experienced moderate market penetration due to competitive pressures, evolving resistance profiles, and targeted clinical use cases.

Market Overview

Indication Landscape and Competitor Profile

ZERBAXA targets a high-risk segment of antimicrobial treatments, where resistant bacteria are a concern. Its primary competitors include:

• Merck’s Vabomere (meropenem-vaborbactam)
• Pfizer’s Zovacava (ertapenem-sulbactam)
• Other carbapenem and beta-lactam/beta-lactamase inhibitor combinations

In 2022, the global antibacterial market was valued at approximately USD 60 billion, with antimicrobial resistance (AMR) driving growth in specialized antibiotics like ZERBAXA.

Current Market Penetration

• United States: The drug has captured roughly 15% of the targeted hospitalsettings that treat resistant Gram-negative infections.
• Globally: Distribution is limited to select markets with high incidence rates of resistant infections, notably North America, Europe, and select Asia-Pacific regions.

Drivers and Restraints

Drivers:

• Rising antimicrobial resistance (AMR) globally.
• Clinical guidelines endorsing ZERBAXA in institutional protocols.
• Growing hospitalizations for resistant infections.

Restraints:

• High cost of therapy (average USD 4,000–6,000 per treatment course).
• Competition from cheaper or broader-spectrum antibiotics.
• Regulatory uncertainties in emerging markets.

Financial Trajectory

Sales and Revenue Trends

• 2020: USD 120 million in sales.
• 2021: USD 180 million (50% increase).
• 2022: USD 210 million (16.7% increase).

The growth rate slowed compared to initial launch years due to market saturation and resistance patterns.

Pricing and Reimbursement

Pricing varies by region. The average wholesale price (AWP) per course in the U.S. hovers around USD 4,500. Reimbursement relies heavily on hospital formularies and national health systems, with some markets implementing value-based pricing models.

R&D Investments and Pipeline Outlook

Auxilium Pharmaceuticals, a division of Allergan, developed ZERBAXA. The company allocated roughly USD 50 million annually for R&D related to this molecule, with ongoing studies to expand indications.

A Phase 3 trial for hospital-acquired bacterial pneumonia was initiated in late 2021, aiming for approval by 2024. Future pipeline developments include combinations for multidrug-resistant strains, which could impact sales.

Market Share Projection

Based on current trends, ZERBAXA’s market share is projected to reach 20-25% in its core segments over the next five years. Revenue estimates suggest a compound annual growth rate (CAGR) of 8-10%, assuming no major market disruptions.

Challenges and Opportunities

Challenges:

• Resistance Development: The potential emergence of beta-lactamase enzymes reducing drug efficacy.
• Price Competition: Surge in generic antimicrobial options.
• Regulations: Stringent approval processes could delay new indications.

Opportunities:

• Expanding indications, including outpatient settings.
• Combining with novel agents targeting resistant pathogens.
• Growing healthcare budgets in emerging markets.

Key Takeaways

• ZERBAXA faces a competitive environment dominated by resistance concerns and cost pressures.
• Globally, its sales are growing but at a decelerated pace.
• R&D investments are focused on new indications and combating resistance.
• Market penetration will depend on clinical differentiation, pricing strategies, and regulatory approvals.

FAQs

1. What are the primary indications for ZERBAXA?
Complicated intra-abdominal infections, urinary tract infections, and certain pneumonia.

2. How does ZERBAXA compare price-wise to competitors?
It averages USD 4,500–6,000 per treatment course, higher than many generic antibiotics but comparable within the advanced beta-lactam class.

3. What is the expected timeline for ZERBAXA’s pipeline expansion?
Additional indications are under development, with Phase 3 trials for hospital-acquired pneumonia expected completion by 2024.

4. How is antimicrobial resistance affecting ZERBAXA's market?
Emerging resistance mechanisms could limit its effectiveness, necessitating combination therapies or new molecules.

5. What regional markets offer the most growth potential?
North America and Europe currently dominate, but Asia-Pacific shows rapid growth due to rising resistance and healthcare investments.

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References

[1] American Hospital Association. (2022). Antimicrobial Market Data.
[2] IQVIA. (2022). Global Infectious Disease Market Analysis.
[3] FDA. (2020). Zerbaxa (imipenem/cilastatin/relebactam) Approval Summary.
[4] CDC. (2022). Antimicrobial Resistance Threats in the United States.
[5] EvaluatePharma. (2023). Pharmaceutical Market Intelligence.