Avibactam sodium; ceftazidime - Generic Drug Details

What are the generic sources for avibactam sodium; ceftazidime and what is the scope of freedom to operate?

Avibactam sodium; ceftazidime is the generic ingredient in one branded drug marketed by Abbvie and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Avibactam sodium; ceftazidime has one hundred and ninety-five patent family members in fifty-five countries.

One supplier is listed for this compound.

Summary for avibactam sodium; ceftazidime

International Patents:	195
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
DailyMed Link:	avibactam sodium; ceftazidime at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for avibactam sodium; ceftazidime

Constraining patent/regulatory exclusivity:

8,969,566

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 avibactam sodium; ceftazidime

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

Sponsor	Phase
Ain Shams University	PHASE2

See all avibactam sodium; ceftazidime clinical trials

Pharmacology for avibactam sodium; ceftazidime

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

Anatomical Therapeutic Chemical (ATC) Classes for avibactam sodium; ceftazidime

J01DD	Third-generation cephalosporins
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for AVIBACTAM SODIUM; CEFTAZIDIME

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 avibactam sodium; ceftazidime

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
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	7,112,592		Y	Y
Abbvie	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes	9,695,122			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	8,471,025			Y

Expired US Patents for avibactam sodium; ceftazidime

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 avibactam sodium; ceftazidime

Country	Patent Number	Title	Estimated Expiration
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)
Turkey	200400859
Slovenia	1307457
Denmark	3269717
Norway	20043587
Lithuania	C1480644
Russian Federation	2727509	Полиморфные и псевдополиморфные формы фармацевтического соединения (POLYMORPHOUS AND PSEUDOPOLYMORPHOUS FORMS OF THE PHARMACEUTICAL COMPOUND)

Supplementary Protection Certificates for avibactam sodium; ceftazidime

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1480644	132016000125850	Italy		PRODUCT NAME: MISCELA O ASSOCIAZIONE FARMACEUTICA CHE COMPRENDE COME PRINCIPI ATTIVI: (1) CEFTAZIDIMA O UN SUO SALE, E (2) AVIBACTAM O UN SUO SALE(ZAVICEFTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1109, 20160628
1480644	58/2016	Austria		PRODUCT NAME: KOMBINATION AUS CEFTAZIDIM UND AVIBACTAM; REGISTRATION NO/DATE: EU/1/16/1109 (MITTEILUNG) 20160628
1480644	2016/056	Ireland		PRODUCT NAME: A COMBINATION OF CEFTAZIDIME OR A SALT THEREOF, AND AVIBACTAM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/16/1109/001 20160624
1480644	2016C/069	Belgium		PRODUCT NAME: ZAVICEFTA (COMBINAISON DE CEFTAZIDIME ET AVIBACTAM); AUTHORISATION NUMBER AND DATE: EU/1/16/1109/001 20160628
1480644	300847	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
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	C01480644/01	Switzerland		PRODUCT NAME: AVIBACTAM + CEFTAZIDIM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66890 05.06.2019

Market Dynamics and Financial Trajectory for AVIBACTAM SODIUM and CEFTAZIDIME

Last updated: August 18, 2025

Introduction

The combination of Avibactam Sodium and Ceftazidime represents a significant advancement in the fight against multidrug-resistant bacterial infections. Approved by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), this drug combination has rapidly integrated into the antimicrobial landscape due to its novel mechanism targeting resistant pathogens. This analysis explores the market dynamics, competitive landscape, revenue forecasts, and strategic factors influencing the financial trajectory of Avibactam Sodium and Ceftazidime.

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Pharmacological Profile and Clinical Significance

Ceftazidime is a third-generation cephalosporin antibiotic effective mainly against Gram-negative bacteria. Its utility has been historically hampered by resistance mechanisms including β-lactamase production. Avibactam Sodium is a β-lactamase inhibitor that restores ceftazidime's efficacy against resistant strains, especially carbapenem-resistant Enterobacteriaceae (CRE), Pseudomonas aeruginosa, and certain strains of Klebsiella pneumoniae.

The combination, marketed as Avycaz or Zavamp in various regions, has demonstrated substantial clinical efficacy, especially in complicated intra-abdominal infections, urinary tract infections, and hospital-acquired pneumonia. Its broad-spectrum activity and innovative mechanism underpin its strategic importance.

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Market Drivers

Rising Antimicrobial Resistance (AMR)

The global escalation in AMR underscores the unmet need for potent antibiotics like the Avibactam-CEFTAZIDIME combination. The increasing prevalence of multidrug-resistant organisms (MDROs), especially carbapenem-resistant Enterobacteriaceae (CRE), propels demand. According to the CDC, resistant infections result in increased morbidity, mortality, and healthcare costs, incrementally bolstering the market for innovative antibiotics [1].

Regulatory Approvals and Market Entry

The initial FDA approval of Avycaz occurred in 2015, with subsequent approvals across key markets including Europe, Asia-Pacific, and Latin America. Regulatory endorsements, driven by compelling clinical trial data, have facilitated rapid uptake among healthcare providers. The regulatory path is more streamlined in developed markets with strong frameworks for critical pathogen coverage.

Clinical Adoption and Prescribing Practices

Physicians increasingly favor antibiotics with proven efficacy against resistant strains. Hospital formulary integrations, supported by infection control protocols, accelerate adoption. The positive outcomes demonstrated in clinical studies, coupled with stewardship programs, enhance confidence in prescribing this combination, reinforcing revenue streams.

Patent Expiration and Generic Competition

As of 2023, certain formulations of ceftazidime have entered the generic market, generating price competition. However, the complex patent landscape surrounding the innovative combination, especially the proprietary non-antibiotic inhibitor component, has delayed generic entry, affording a period of exclusivity and higher margins [2].

Manufacturing and Supply Chain Factors

Efficient manufacturing processes, robust supply chains, and partnerships with contract manufacturing organizations (CMOs) have stabilized product availability, reducing risks of shortages and ensuring consistent revenue.

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Market Challenges and Risks

Pricing Pressures and Reimbursement Policies

Healthcare payers are increasingly scrutinizing high-cost antibiotics. In regions like North America and Europe, reimbursement negotiations challenge profitability. Value-based pricing models depend on demonstrable clinical benefits over existing therapies, influencing revenue projections.

Emergence of Resistance to the Combination

While current efficacy against resistant strains is promising, the potential development of resistance to the Avibactam-CEFTAZIDIME combination could diminish its market share over time. Continuous surveillance and stewardship are critical to prolonging its utility.

Competition and Alternative Therapies

Emergent antibiotics targeting resistant pathogens, such as Meropenem-Vaborbactam and Relabactam-based combinations, imply a competitive marketplace. Biosimilars and generics may erode margins post-patent expiry, impacting long-term revenue.

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Financial Trajectory and Revenue Forecast

Market Size and Growth Projections

The global antimicrobial agents market was valued at approximately USD 46 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of around 3–5% through 2030, driven by rising AMR and an aging population [3].

The segment specific to β-lactam/β-lactamase inhibitor combinations is expected to register higher growth rates (~7%), owing to their novel spectrum and clinical efficacy. Within this segment, Avibactam-based products are key contributors, especially in North America and Europe.

Revenue Estimates

Analysts project that Avibactam-CEFTAZIDIME sales will reach USD 750–1,200 million annually by 2025, with North America accounting for approximately 60% of revenues owing to reimbursement policies and hospital utilization patterns. Growth will depend on the extent of clinical adoption, resistance patterns, and pricing strategies.

Market Penetration Strategy

Pharmaceutical companies plan targeted marketing toward hospital formulary committees and infectious disease specialists. Strategic partnerships with governmental agencies and participation in antimicrobial stewardship initiatives further amplify market penetration.

Impact of Patent and Regulatory Developments

Patent protection, expected to extend until approximately 2028–2030 in major markets, provides temporary market exclusivity, enabling pricing power. Following patent expiry, generic competition could reduce prices by 30–50%, impacting revenue unless sustained by new indications or combination formulations.

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Strategic Factors Influencing Future Market Performance

Innovation and Pipeline Development

Continued R&D investments to develop next-generation β-lactamase inhibitors and combination therapies will shape future revenue streams. Expanding indications, such as bloodstream infections and immunocompromised patient populations, could unlock additional markets.

Global Access and Pricing

Expanding into emerging markets (India, China, Brazil) offers substantial growth potential. Price sensitivity and regulatory hurdles necessitate tiered pricing strategies and local collaborations to optimize access and revenue.

Antimicrobial Stewardship and Usage Policies

Stewardship programs aim to restrict broad-spectrum antibiotic use to designated cases, potentially limiting immediate volume growth. Nonetheless, effective stewardship preserves drug efficacy, ultimately stabilizing long-term revenue.

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Conclusion

The commercial fortunes of Avibactam Sodium and Ceftazidime hinge on a combination of clinical efficacy, resistance trends, regulatory landscape, and market strategies. While current demand remains robust—primarily driven by rising AMR—the industry faces imminent challenges from pricing pressures, potential resistance development, and patent expiries. Proactive R&D, strategic partnerships, and market expansion are essential to sustain positive financial trajectories.

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Key Takeaways

• Market drivers like rising antimicrobial resistance and regulatory approvals underpin demand growth for Avibactam-CEFTAZIDIME.
• Revenue prospects for 2023–2025 are projected at USD 750–1,200 million annually, with North America leading sales.
• Patent protections grant exclusive rights until approximately 2028–2030, after which generic competition could pressure prices.
• Innovation pipelines and expanded indications are critical to maintaining market relevance amid emerging competitors.
• Global access strategies, including pricing and partnerships, are vital for capturing growth in emerging markets.

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FAQs

1. What is the primary clinical advantage of combining avibactam with ceftazidime?
   It restores ceftazidime’s efficacy against resistant Gram-negative bacteria, especially carbapenem-resistant strains, by inhibiting β-lactamases that inactivate ceftazidime.

2. How does antimicrobial resistance influence the market for this drug combination?
   The surge in resistant pathogens amplifies demand by creating urgent clinical needs for effective therapies, thereby bolstering sales and expanding markets.

3. What are the key challenges facing the commercial success of avibactam-ceftazidime?
   Challenges include pricing pressures, resistance development, competition from new antibiotics, and eventual patent expiry leading to generic entry.

4. Which regions are most significant for the revenue generation of this drug?
   North America dominates, followed by Europe and Asia-Pacific, driven by healthcare infrastructure, AMR prevalence, and regulatory approvals.

5. What is the outlook for new indications or formulations?
   Ongoing clinical trials aim to expand indications (e.g., bloodstream infections) and formulations, potentially creating additional revenue streams and extending product lifecycle.

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Sources

1. CDC. Antibiotic Resistance Threats in the United States, 2019.
2. PatentScope. Global patent status of β-lactamase inhibitors.
3. MarketsandMarkets. Antimicrobial Agents Market Forecast, 2021–2030.