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 sixteen 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:	116
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
Royal Brisbane and Women's Hospital	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 and one FDA Regulatory Exclusivity.

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
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	10,125,149		Y

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
Mexico	352760	METODOS PARA TRATAR INFECCIONES INTRAPULMONARES. (METHODS FOR TREATING INTRAPULMONARY INFECTIONS.)
Spain	2800603
Austria	368042
New Zealand	718365
Japan	2021102652	セフトロザン抗生物質組成物 (CEFTOLOZANE ANTIBIOTIC COMPOSITIONS)
Chile	2015002755

Supplementary Protection Certificates for ZERBAXA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C01556389/01	Switzerland		PRODUCT NAME: CEFTOLOZAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65472 03.03.2016
1556389	6/2016	Austria		PRODUCT NAME: CEFTOLOZAN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE EIN SCHWEFELSAEURESALZ; REGISTRATION NO/DATE: EU/1/15/1032/001 (MITTEILUNG) 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
1556389	16C0004	France		PRODUCT NAME: CEFTOLOZANE,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,PLUS PARTICULIEREMENT UN SEL D'ACIDE SULFURIQUE; REGISTRATION NO/DATE: EU/1/15/1032 20150922
1556389	602	Finland

Market Dynamics and Financial Trajectory for ZERBAXA

Last updated: September 30, 2025

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Introduction

ZERBAXA (cefiderocol) is an innovative cephalosporin antibiotic developed by Shionogi and initially approved by the U.S. Food and Drug Administration (FDA) in 2019 for treatment of complicated urinary tract outbreaks (cUTI), complicated intra-abdominal infections (cIAI), and hospital-acquired bacterial pneumonia/veterinary ventilator-associated pneumonia (HABP/VABP). Its unique mechanism, utilizing siderophore-mediated iron uptake, positions it as a promising agent against multidrug-resistant (MDR) Gram-negative bacteria, a critical concern for global health. This analysis explores the market dynamics influencing ZERBAXA's commercial trajectory, alongside its financial outlook amidst evolving antimicrobial resistance landscapes.

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Market Landscape and Competitive Environment

Escalating Antimicrobial Resistance (AMR) Crisis

The rise of MDR Gram-negative pathogens—such as carbapenem-resistant Enterobacteriaceae (CRE), Pseudomonas aeruginosa, and Acinetobacter baumannii—has accentuated the urgent need for novel antibiotics like ZERBAXA. According to the CDC, if current trends persist, by 2030, resistant infections could cause over 10 million deaths annually worldwide. Existing therapeutic options are limited, and resistance to current agents in the same class (e.g., carbapenems) is rising sharply, narrowing treatment options.

Competitive Positioning

ZERBAXA's primary competitors include traditional agents like meropenem, colistin, fosfomycin, and newer drugs such as plazomicin and cefiderocol's close relatives. The FDA-approved label positions ZERBAXA as a last-line agent, especially targeting MDR infections. Its distinctive siderophore-chelated mechanism grants an advantage in penetrating resistant bacterial defenses, but its high cost and specific indication scope hinder widespread adoption.

Market Penetration and Adoption Challenges

Despite its potent profile, ZERBAXA faces hurdles in market penetration. Its high acquisition cost, limited antibiotic stewardship guidelines, and relatively narrow approved indications restrict routine use. Moreover, physicians often reserve such drugs for confirmed or suspected resistant cases, which delays broad utilization. The antimicrobial stewardship movement further advocates prudent use, constraining rapid sales growth.

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Regulatory and Clinical Development Trajectory

FDA and Global Approvals

Since its initial approval in the U.S., ZERBAXA has gained regulatory acceptance in other jurisdictions, including the European Union and Japan, albeit with varying indications. Pending approvals in key markets like China and India could expand its footprint substantially. The ongoing phase 3 clinical trial programs targeting a broader range of infections aim to solidify its position.

Clinical Trials and Post-Marketing Evidence

Continued real-world evidence demonstrating efficacy against resistant infections bolsters its value proposition. Recent studies underscore ZERBAXA's efficacy against carbapenem-resistant infections, a tier-one healthcare priority. Regulatory bodies globally may expedite approvals or extend indications based on emerging data.

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Market Dynamics Influencing ZERBAXA’s Financial Prospects

Pricing Strategy and Reimbursement Environment

ZERBAXA’s premium pricing reflects its novel mechanism and targeted indication. However, reimbursement challenges hinge on health system willingness to accept higher costs for last-line agents. Payer negotiations, especially in price-sensitive markets, influence volume sales. In the U.S., Medicare and private insurers' stewardship programs may limit usage, impacting revenue.

Pharmacoeconomic Considerations

Cost-effectiveness analyses showcasing long-term savings through effective treatment of MDR infections support pricing strategies. Countries emphasizing antimicrobial stewardship are likely to favor agents proven to shorten hospital stays and reduce mortality, positioning ZERBAXA favorably if such data emerge.

Market Penetration Strategies

Shionogi’s global licensing agreements and marketing efforts focus on hospitals, infectious disease specialists, and antimicrobial stewardship committees. Growing awareness of antimicrobial resistance boosts demand, yet high unmet need and limited current use restrict rapid revenue growth initially.

Patent Status and Generic Competition

As ZERBAXA's patent protections extend into the late 2020s, generic competition appears unlikely in the near term, allowing sustained premium pricing. However, future biosimilar or alternative agents could challenge its market share if clinical or regulatory hurdles are overcome.

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Financial Outlook and Revenue Projections

Current Revenue and Growth Trends

Since its launch, ZERBAXA's sales have been modest, consistent with its specialized role and stewardship restrictions, with an estimated revenue of approximately $60-80 million globally in 2022. Its growth trajectory hinges on expanding approved indications, broader payer acceptance, and increased clinical adoption, especially in hospital settings managing MDR infections.

Forecasted Market Expansion

Analysts project moderate but steady growth, potentially reaching around $200-300 million annually within five years. Expansion into emerging markets with high AMR burdens, such as India and China, could contribute significantly. Clinical trial successes and expanded indications are catalysts for accelerated revenue growth.

Potential Revenue Impact of Broader Use

Additional approvals for indications like pneumonia and bloodstream infections, along with favorable post-marketing surveillance, could double or triple sales. Incorporation into hospital formularies and inclusion in antimicrobial stewardship protocols will jointly influence revenue trajectories.

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Emerging Market Dynamics and Future Opportunities

Unmet Needs and Emerging Resistance Patterns

Regions with high MDR prevalence—Asia-Pacific, Latin America, Middle East—offer fertile grounds for ZERBAXA’s use. The ongoing rise of carbapenem-resistant bacteria positions ZERBAXA as a strategic option. The priority remains generating robust clinical data to support expanded indications and securing reimbursement pathways.

Innovation and Pipeline Development

Shionogi’s pipeline includes potential derivatives or combination therapies to extend ZERBAXA’s utility. Combination regimens with β-lactamase inhibitors or other novel agents could enhance efficacy and reduce resistance development, opening new revenue streams.

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Regulatory and Market Challenges

Antimicrobial stewardship: Increasing restrictions on broad-spectrum antibiotics to prevent resistance may slow sales growth.

Cost considerations: High drug prices necessitate strong evidence of clinical benefit to justify reimbursement, especially in cost-sensitive markets.

Competition: Emergence of alternative therapies, including phage-based agents or new antibiotics in the pipeline, could impact ZERBAXA’s market share.

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Key Takeaways

• Rising antimicrobial resistance significantly enhances ZERBAXA's value proposition, though utilization remains limited by stewardship protocols and cost constraints.

• Market expansion depends on securing regulatory approvals for broader indications and in emerging markets, leveraging its unique siderophore mechanism.

• Pricing and reimbursement strategies are critical; demonstration of clear clinical benefits will determine long-term financial viability.

• Growth potential exists but is constrained in the short term; revenue forecasts approximately project reaching $200-300 million annually within five years, contingent on clinical and regulatory success.

• Future avenues include pipeline development, combination therapies, and strategic market positioning to address the burgeoning global AMR crisis effectively.

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FAQs

Q1: What differentiates ZERBAXA from other antibiotics targeting MDR Gram-negative bacteria?
A1: ZERBAXA employs a novel siderophore-mediated approach, enabling it to bypass some resistance mechanisms that render other antibiotics ineffective. This iron-chelating mechanism enhances bacterial penetrance, especially against carbapenem-resistant strains.

Q2: How does antimicrobial stewardship impact ZERBAXA’s market growth?
A2: Stewardship programs promote judicious antibiotic use, often reserving powerful agents like ZERBAXA for confirmed resistant infections. While essential for combating resistance, these protocols can restrict immediate widespread adoption, limiting short-term revenue growth.

Q3: In which regions does ZERBAXA have the greatest market potential?
A3: Countries with high MDR Gram-negative infection burdens, notably in Asia-Pacific, Latin America, and the Middle East, represent significant opportunities due to unmet clinical needs and evolving resistance patterns.

Q4: What is the outlook for ZERBAXA’s commercial success over the next five years?
A4: While initial sales are modest, expansion through broader approvals and indications could lead to annual revenues of up to $300 million, driven by increasing global AMR awareness and strategic market efforts.

Q5: Are there significant competitors that could threaten ZERBAXA’s market share?
A5: Yes. New antibiotics in development (e.g., combined β-lactamase inhibitors), alternative therapies like phages, or generics post-patent expiry could challenge ZERBAXA’s dominance, emphasizing the importance of clinical data and clinical niche positioning.

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References

1. CDC. Antibiotic Resistance Threats in the United States, 2019.
2. European Medicines Agency. ZERBAXA Summary of Product Characteristics.
3. Shionogi Inc. ZERBAXA (cefiderocol) Launch and Market Data.
4. Global Data. Antimicrobial Market Forecasts and Competitive Analysis.
5. World Health Organization. Global Action Plan on Antimicrobial Resistance.

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In conclusion, ZERBAXA’s market dynamics are heavily shaped by the global AMR crisis, regulatory strategies, and stewardship policies. Although its current financial trajectory is modest, strategic expansion, continued clinical validation, and favorable reimbursement scenarios could propel it into a key position in combating resistant infections, ultimately translating into sustained revenue growth and substantial public health impact.