AVIBACTAM SODIUM; AZTREONAM - Generic Drug Details

What are the generic sources for avibactam sodium; aztreonam and what is the scope of patent protection?

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

One supplier is listed for this compound.

Summary for AVIBACTAM SODIUM; AZTREONAM

International Patents:	195
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	AVIBACTAM SODIUM; AZTREONAM at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AVIBACTAM SODIUM; AZTREONAM

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

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 AVIBACTAM SODIUM; AZTREONAM

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

Anatomical Therapeutic Chemical (ATC) Classes for AVIBACTAM SODIUM; AZTREONAM

J01DF	Monobactams
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for AVIBACTAM SODIUM; AZTREONAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	EMBLAVEO	avibactam sodium; aztreonam	POWDER;INTRAVENOUS	217906-001	Feb 7, 2025		RX	Yes	Yes
Abbvie	EMBLAVEO	avibactam sodium; aztreonam	POWDER;INTRAVENOUS	217906-001	Feb 7, 2025		RX	Yes	Yes	7,112,592		Y	Y
Abbvie	EMBLAVEO	avibactam sodium; aztreonam	POWDER;INTRAVENOUS	217906-001	Feb 7, 2025		RX	Yes	Yes	9,284,314			Y
Abbvie	EMBLAVEO	avibactam sodium; aztreonam	POWDER;INTRAVENOUS	217906-001	Feb 7, 2025		RX	Yes	Yes	8,835,455		Y
Abbvie	EMBLAVEO	avibactam sodium; aztreonam	POWDER;INTRAVENOUS	217906-001	Feb 7, 2025		RX	Yes	Yes	7,612,087		Y
Abbvie	EMBLAVEO	avibactam sodium; aztreonam	POWDER;INTRAVENOUS	217906-001	Feb 7, 2025		RX	Yes	Yes	8,471,025			Y

International Patents for AVIBACTAM SODIUM; AZTREONAM

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

Supplementary Protection Certificates for AVIBACTAM SODIUM; AZTREONAM

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

Market Dynamics and Financial Trajectory for AVIBACTAM SODIUM and AZTREONAM

Last updated: July 30, 2025

Introduction

The combination of Avibactam Sodium and Aztreonam represents a promising therapeutic approach against multidrug-resistant bacterial infections. This pairing leverages Avibactam’s β-lactamase inhibition with Aztreonam’s stability against certain β-lactamases, targeting serious Gram-negative infections, including those caused by carbapenem-resistant Enterobacteriaceae (CRE). Analyzing their market dynamics and projected financial trajectory requires understanding clinical, regulatory, and competitive landscapes.

Market Fundamentals and Unmet Medical Need

The global burden of antibiotic resistance escalates annually, with the World Health Organization (WHO) declaring it an imminent threat. CRE, Pseudomonas aeruginosa, and Acinetobacter baumannii infections are challenging to treat due to limited options. Aztreonam, a monobactam antibiotic, retains activity against Gram-negative bacteria resistant to other β-lactams, but its efficacy is often compromised by β-lactamase-producing strains. Avibactam, a novel non-β-lactam β-lactamase inhibitor, broadens Aztreonam’s spectrum, restoring activity against resistant strains.

Given this synergy, Avibactam-aztreonam combinations address significant unmet medical needs, positioning them as critical assets in combating antimicrobial resistance (AMR). This aligns with increasing regulatory interest and development investments driven by substantial clinical demand.

Regulatory Status and Pipeline Development

Several pharmaceutical companies have advanced Avibactam-Aztreonam combinations into clinical development phases. Notably, the combination has been evaluated in phase 3 clinical trials focusing on complicated urinary tract infections, intra-abdominal infections, and pneumonia. U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have shown openness to novel mechanisms addressing resistant infections, which could facilitate expedited approvals.

In late 2022, Under the brand Aztreonam-Avibactam (Avycaz® in some formulations), regulatory submissions are underway, with projected approval timelines influencing market entry strategies.

Market Size and Revenue Potential

The global antibiotic market was valued around $47 billion in 2022, with projections indicating a compound annual growth rate (CAGR) of approximately 3–5% through 2030. The urgent need for resistant infection treatments constitutes a high-growth niche within this space. The market for β-lactam/β-lactamase inhibitors (BL/BLI)—such as Avibactam-based therapies—has been expanding, with some estimates projecting a valuation exceeding $7 billion by 2030.

Particularly, the resistant Gram-negative infection niche is expected to be the primary revenue generator. The high prevalence of carbapenem-resistant pathogens, especially in hospital settings in North America, Europe, and Asia-Pacific, fuels demand. The commercial potential hinges on successful clinical outcomes, regulatory approvals, and positioning against existing treatments like Merck's Zerbaxa and AstraZeneca’s Treoza.

Competitive Landscape

The antimicrobial market features several key players:

• Pfizer’s Zerbaxa (cefepime/zidebactam).
• Gilead Sciences’s Tebipenem pivoxil.
• Bayer’s Vazculep and other investigational agents.
• Merck’s Zerbaxa.

The unique mechanism of Avibactam combined with Aztreonam offers differentiation, especially against carbapenemase-producing organisms.

Furthermore, next-generation β-lactamase inhibitors like Relebactam and Vaborbactam are diversifying options, intensifying competitive pressures. However, the specific activity against metallo-β-lactamases (MBLs) positions Avibactam-Aztreonam as a critical solution in multidrug-resistant infection management.

Pricing and Reimbursement Landscape

Pricing strategies for novel antibiotics are influenced by development costs, clinical efficacy, stewardship policies, and market competition. High-income markets view antibiotics as premium-priced therapies; estimates suggest unit prices could range from $2,000 to $5,000 per treatment course.

Reimbursement depends on payer acceptance, demonstrated clinical value, and adherence to antimicrobial stewardship. Given their targeted niche, payers may prioritize coverage for resistant infections, recognizing the potential to reduce hospital stays and prevent costly complications.

Market Entry and Commercialization Strategies

Effective market penetration will depend on:

• Regulatory approval timelines.
• Strategic collaborations with hospitals and infectious disease specialists.
• Robust clinical data demonstrating superior efficacy and safety.
• Stewardship programs aligning usage with resistance mitigation.

Pharmaceutical companies might adopt patent protections, market exclusivity, and targeted educational initiatives to maximize revenue streams.

Financial Trajectory and Investment Outlook

The initial phase post-approval is characterized by:

• R&D investments, including ongoing clinical trials, expected to total hundreds of millions of dollars.
• Regulatory approval influences, with expedited pathways shortening time-to-market (estimated at 2–3 years post-partial data).
• Market adoption rates, influenced by clinical guidelines and prescriber comfort with novel agents.

Long-term, revenues could reach $1–3 billion annually in high-resistance infection markets, contingent upon:

• Approval success.
• Clinical adoption.
• Competitive positioning.
• Pricing and reimbursement policies.

Given the critical need and the limited number of effective agents, the financial outlook remains optimistic for manufacturers involved in successful development and commercialization.

Regulatory and Market Challenges

Challenges include:

• Antibiotic stewardship concerns limiting widespread use.
• Resistance development reducing long-term efficacy.
• Pricing pressures and conservative reimbursement policies.
• Clinical trial complexities due to the variability of infection types.

Addressing these challenges requires robust clinical evidence, strategic collaborations, and adaptable commercialization plans.

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Key Takeaways

• The Avibactam sodium and Aztreonam combination addresses a substantial unmet need against multidrug-resistant Gram-negative bacteria, potentially transforming treatment paradigms.
• Regulatory approval timelines and clinical trial results will significantly influence market entry and revenue projections.
• The target market is poised for growth, with high resistance prevalence and limited effective therapies driving demand.
• Competitive differentiation hinges on the combination’s ability to counteract MBL-producing organisms and its demonstrated safety profile.
• Pricing, reimbursement, and stewardship policies will shape long-term financial outcomes, emphasizing the need for strategic planning.

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FAQs

1. What makes the Avibactam-aztreonam combination unique among antibiotics?
It effectively inhibits β-lactamases, including carbapenemases and MBLs, restoring activity against resistant Gram-negative bacteria that are often unresponsive to other therapies.

2. How soon could this combination become available on the market?
Pending regulatory approval—expected within 12-24 months of complete clinical data—subject to approval timelines in different regions.

3. What are the primary clinical indications for this combination?
Infections caused by carbapenem-resistant Enterobacteriaceae (CRE), complicated urinary tract infections, intra-abdominal infections, and pneumonia.

4. What barriers could hinder the market success of Avibactam-aztreonam?
Stewardship restrictions, resistance emergence, high pricing, and competition from existing antibiotics could limit adoption.

5. How will pricing strategies impact the financial trajectory?
Premium pricing aligned with targeted indications and demonstrated clinical value will be crucial; payers' acceptance will influence profitability and market penetration.

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References

1. World Health Organization. (2021). "Antimicrobial resistance global report."
2. MarketsandMarkets. (2022). "Antibiotics Market by Application, Type, and Region."
3. U.S. Food and Drug Administration. (2023). "Expedited programs for certain drugs."
4. Grand View Research. (2023). "Antimicrobial Resistance Market Analysis."
5. ClinicalTrials.gov. (2023). "Avibactam and Aztreonam Combination Trials."