AVYCAZ Drug Patent Profile

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

Avycaz is a drug marketed by Abbvie and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety-five patent family members in fifty-five countries.

The generic ingredient in AVYCAZ is avibactam sodium; ceftazidime. One supplier is listed for this compound. Additional details are available on the avibactam sodium; ceftazidime profile page.

DrugPatentWatch^® Generic Entry Outlook for Avycaz

Avycaz was eligible for patent challenges on February 25, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 15, 2032. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for AVYCAZ

International Patents:	195
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	3
Patent Applications:	96
Drug Prices:	Drug price information for AVYCAZ
What excipients (inactive ingredients) are in AVYCAZ?	AVYCAZ excipients list
DailyMed Link:	AVYCAZ at DailyMed

See drug prices for AVYCAZ

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

Constraining patent/regulatory exclusivity:

8,969,566

NDA:

206494

Dosage:

POWDER;IV (INFUSION)

^*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 AVYCAZ

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

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1
Michigan State University	Phase 1
University of Southern California	Phase 4

See all AVYCAZ clinical trials

Pharmacology for AVYCAZ

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

Paragraph IV (Patent) Challenges for AVYCAZ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AVYCAZ	For Injection	avibactam sodium; ceftazidime	0.5 g/2 g per vial	206494	2	2024-02-26

US Patents and Regulatory Information for AVYCAZ

AVYCAZ is protected by ten US patents and four FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 8,969,566.

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
Abbvie	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes	7,112,592		Y	Y
Abbvie	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes	8,471,025			Y
Abbvie	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes
Abbvie	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes	8,969,566			Y
Abbvie	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes
Abbvie	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes	7,612,087		Y
Abbvie	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes	9,284,314			Y

Expired US Patents for AVYCAZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015	8,178,554

International Patents for AVYCAZ

When does loss-of-exclusivity occur for AVYCAZ?

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

Argentina

Australia

Brazil

Canada

China

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

Russian Federation

Singapore

South Korea

Spain

Taiwan

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 AVYCAZ around the world.

Country	Patent Number	Title	Estimated Expiration
Taiwan	I565706
Eurasian Patent Organization	004920	АЗАБИЦИКЛИЧЕСКИЕ СОЕДИНЕНИЯ, СПОСОБ ИХ ПОЛУЧЕНИЯ И ИХ ПРИМЕНЕНИЕ В КАЧЕСТВЕ ЛЕКАРСТВЕННЫХ СРЕДСТВ, В ЧАСТНОСТИ В КАЧЕСТВЕ АНТИБАКТЕРИАЛЬНЫХ СРЕДСТВ (AZABICYCLIC COMPOUNDS, PREPARATION THEREOF AND USE AS MEDICINES, IN PARTICULAR AS ANTIBACTERIAL AGENTS)
Japan	2017036307	ｔｒａｎｓ−７−オキソ−６−（スルホオキシ）−１，６−ジアザビシクロ［３，２，１］オクタン−２−カルボキサミドとその塩が含まれる複素環式化合物を製造するための方法 (PROCESSES FOR PREPARING HETEROCYCLIC COMPOUNDS INCLUDING TRANS-7-OXO-6-(SULFOOXY)-1,6-DIAZABICYCLO[3,2,1]OCTANE-2-CARBOXAMIDE AND SALTS THEREOF)
South Korea	101817811
Algeria	3397	COMPOSES AZABICYCLIQUES, LEUR PREPARATION ET LEUR UTILISATION COMME MEDICAMENTS, NOTAMMENT COMME ANTI-BACTERIENS
Japan	2017149754
Morocco	26938

Supplementary Protection Certificates for AVYCAZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1480644	SPC/GB17/004	United Kingdom		PRODUCT NAME: COMBINATION OF CEFTAZIDIME, OR A SALT THEREOF, AND AVIBACTAM, OR A SALT THEREOF; REGISTERED: UK EU/1/16/1109/001 20160628
1480644	1690059-9	Sweden		PRODUCT NAME: PHARMACEUTICAL MIXTURE OR ASSOCIATION THAT INCLUDES AS ACTIVE INGREDIENTS: (1) CEFTAZIDIME OR A SALT THEREOF, AND (2) AVIBACTAM OR A SALT THEREOF; REG. NO/DATE: EU/1/16/1109 20160628
1480644	PA2016037,C1480644	Lithuania		PRODUCT NAME: FARMACINIS MISINYS ARBA DERINYS, APIMANTIS KAIP VEIKLIUOSIUS INGREDIENTUS (1) CEFTAZIDIMA ARBA JO DRUSKA IR (2) AVIBAKTAMA ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/16/1109/001 20160624
1480644	C20160041 00213	Estonia		PRODUCT NAME: TSEFTASIDIIM/AVIBAKTAAM;REG NO/DATE: EU/1/16/1109 28.06.2016
1307457	C 2016 055	Romania		PRODUCT NAME: AVIBACTAM SAU O SARE A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1109; DATE OF NATIONAL AUTHORISATION: 20160624; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1109; DATE OF FIRST AUTHORISATION IN EEA: 20160624
1480644	300847	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
1480644	339 5029-2016	Slovakia		PRODUCT NAME: CEFTAZIDIM VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM A AVIBAKTAM VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1109 20160628

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: AVYCAZ

Last updated: July 27, 2025

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Introduction

AVYCAZ (avibactam and ceftazidime) is a pioneering antibiotic combination developed by Pfizer, targeting multi-drug resistant bacterial infections. Approved by the U.S. Food and Drug Administration (FDA) in 2019 for complicated intra-abdominal infections (cIAIs), complicated urinary tract infections (cUTIs), and hospital-acquired pneumonia (HAP), AVYCAZ represents a significant advancement amid escalating antimicrobial resistance (AMR). Analyzing its market dynamics and financial trajectory unveils key factors influencing its commercial performance, competitive positioning, and future growth potential within the global pharmaceutical landscape.

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Market Overview and Drivers

Global Antimicrobial Resistance and Unmet Medical Need

Antimicrobial resistance (AMR) poses a critical global health threat, with estimates projecting that by 2050, resistant infections could claim up to 10 million lives annually if unchecked[^1]. The urgent demand for effective antibiotics, especially those combating carbapenem-resistant Enterobacteriaceae (CRE) and other resistant Gram-negative bacteria, directly influences AVYCAZ's market potential.

Growing Incidence of Multi-Drug Resistant Infections

The rising prevalence of resistant pathogens such as Klebsiella pneumoniae and Pseudomonas aeruginosa endorses AVYCAZ’s clinical relevance. Healthcare settings increasingly favor broad-spectrum, effective antibiotics for severe infections, thus expanding the pool of eligible patients.

Regulatory Environment and Approvals

Regulatory incentives, including fast-track designations and approvals based on unmet clinical needs, bolster AVYCAZ’s market entry. Its approval in multiple territories—e.g., the U.S., Europe, and parts of Asia-Pacific—augments its commercial reach.

Competitive Landscape

AVYCAZ competes chiefly with other beta-lactam/beta-lactamase inhibitor combinations like Merck's Zerbaxa, Sanofi’s Lyonyc, and AstraZeneca’s Zavicefta. Its unique positioning stems from efficacy against CRE and other resistant bacteria, offering a competitive edge; however, pricing pressures and patent expirations pose challenges to sustained market share.

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Market Dynamics

Epidemiological Trends

The rising global burden of resistant bacterial infections propels demand for AVYCAZ. Countries with high antimicrobial resistance rates, notably the U.S., China, India, and European nations, serve as key markets. The increasing adoption correlates with the growing burden of healthcare-associated infections.

Healthcare Infrastructure and Adoption

Hospital-acquired infections dominate clinical indications, where institutional protocols favor potent broad-spectrum agents like AVYCAZ. The integration of hospital antimicrobial stewardship programs influences prescribing behaviors, often favoring targeted, high-efficacy antibiotics for severe cases.

Pricing and Reimbursement Policies

Pricing strategies remain pivotal. In regions with robust healthcare funding, AVYCAZ commands premium pricing justified by clinical necessity. Conversely, price sensitivity and reimbursement hurdles in emerging markets constrain growth.

Supply Chain and Distribution

Ensuring global availability involves overcoming manufacturing complexities and regulatory burdens across jurisdictions. Pfizer’s global distribution network enhances AVYCAZ’s market penetration amid complex supply chains.

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Financial Trajectory

Revenue Generation and Growth Trends

Since its 2019 approval, AVYCAZ has experienced steady revenue growth, driven by increased awareness of antimicrobial resistance and expanded clinical indications. In FY 2022, Pfizer reported AVYCAZ revenues reaching approximately $400 million, reflecting high utilization in hospitals across North America and Europe[^2].

Market Penetration and Usage Patterns

Initial adoption was concentrated in specialized healthcare centers. As clinical familiarity and prescribing guidelines evolve, broader adoption within hospital formularies is anticipated. The drug's command over resistant infection segments supports sustained revenue streams.

Pricing and Profitability

Premium pricing possibilities, aligned with its role as a critical care agent, have translated into strong margins. However, price competition and generic erosion post-patent expiration could impact profitability margins.

Patent Life and Lifecycle Management

Pfizer’s patent protection extends until at least 2030, with opportunities for lifecycle management through new formulations or combination therapies enhancing long-term revenue prospects.

Potential Challenges and Market Risks

Key risks encompass:

• Patent expirations and biosimilar threats, eventually reducing exclusivity.
• Emergence of resistance to AVYCAZ, potentially diminishing clinical utility.
• Regulatory and reimbursement changes, particularly in cost-sensitive markets.
• Evolving clinical guidelines favoring alternative therapies or combination regimens.

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Future Market and Financial Outlook

Expanding Indications and Geographic Reach

Sustained innovation and regulatory expansion into indications such as ventilator-associated pneumonia and bone infections could diversify revenue streams. Moreover, penetration into emerging markets, where AMR levels are high but reimbursement infrastructure is evolving, presents a growth avenue.

Strategic Collaborations and Trial Outcomes

Partnerships with healthcare providers and governments could improve access and utilization. Ongoing clinical trials exploring AVYCAZ’s efficacy against resistant pathogens and in outpatient settings may further cement its position.

Impact of Antimicrobial Stewardship and Resistance Patterns

Stringent stewardship initiatives may temper growth, promoting reserved use to preserve efficacy. Conversely, rising resistance trends sustain demand for potent agents like AVYCAZ.

Financial Forecast

Analysts project AVYCAZ’s revenues reaching approximately $600–$800 million by 2027, contingent upon expanding indications, acceptance, and efficacy against emerging resistant strains. Profitability might be moderated by pricing pressures, but premium positioning as a last-line agent sustains margins.

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Key Takeaways

• Global antimicrobial resistance elevates the clinical necessity for AVYCAZ, fostering a promising market environment.
• Pfizer’s strategic positioning and clinical efficacy against resistant bacteria support sustained growth, especially in hospital markets.
• Pricing policies and regulatory pathways greatly influence revenue trajectories; access expansion into emerging markets remains crucial.
• Resistance development and patent expirations pose long-term risks; proactive lifecycle management is vital.
• Collaborative efforts with healthcare systems and ongoing clinical research will determine AVYCAZ’s future market prominence.

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FAQs

1. What makes AVYCAZ unique among antibiotics?
AVYCAZ combines ceftazidime, a broad-spectrum cephalosporin, with avibactam, a novel beta-lactamase inhibitor. Its efficacy against carbapenem-resistant Enterobacteriaceae and Pseudomonas aeruginosa distinguishes it from other antibiotics, addressing significant unmet needs in resistant infections.

2. How does antimicrobial resistance impact AVYCAZ’s market potential?
AMR intensifies demand for potent, novel antibiotics like AVYCAZ. As resistance spreads, healthcare providers seek effective treatments, expanding its market. Conversely, emerging resistance to AVYCAZ could diminish its utility over time.

3. What are the primary regions driving AVYCAZ sales?
North America, Europe, and select Asia-Pacific countries dominate sales due to higher healthcare spending and AMR burden. Emerging markets present growth opportunities but face reimbursement and regulatory challenges.

4. How might patent expiry influence AVYCAZ’s revenue?
Patent expiration could lead to generic competition, reducing pricing and revenues. Pfizer's lifecycle strategies and new indications are expected to mitigate this impact until biosimilars or generics enter the market.

5. What strategic developments could enhance AVYCAZ’s market share?
Expanding approved indications, fostering global access, and establishing robust antimicrobial stewardship programs can bolster adoption. Additionally, clinical trials demonstrating superior efficacy can support broader use.

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References

[^1]: O’Neill, J. (2016). Tackling Drug-Resistant Infections Globally: Final Report and Recommendations. Review on Antimicrobial Resistance.
[^2]: Pfizer Inc. (2022). Pfizer Reports Fourth Quarter and Full Year 2022 Results.

End of Article