avibactam sodium; aztreonam - Profile

What are the generic drug 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.

Summary for avibactam sodium; aztreonam

International Patents:	195
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for avibactam sodium; aztreonam

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.

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	7,112,592		Y	Y
Abbvie	EMBLAVEO	avibactam sodium; aztreonam	POWDER;INTRAVENOUS	217906-001	Feb 7, 2025		RX	Yes	Yes	8,969,566			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	9,695,122		Y	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

Expired US Patents for avibactam sodium; aztreonam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	EMBLAVEO	avibactam sodium; aztreonam	POWDER;INTRAVENOUS	217906-001	Feb 7, 2025	7,112,592

International Patents for avibactam sodium; aztreonam

Country	Patent Number	Title	Estimated Expiration
African Regional IP Organization (ARIPO)	1614	New heterocyclic compounds, their preparation and their use as medicaments, in particular as anti-bacterial agents.
Argentina	031716	DERIVADOS DE 1-AZA Y 1,3- DIAZABICICLOETANOS Y ANALOGOS, UN PROCEDIMIENTO PARA SU PREPARACION, Y COMPOSICION FARMACEUTICA Y MEDICAMENTOS COMO ANTIBACTERIANOS
Austria	263768
Australia	2001279905
Australia	7990501
Bulgaria	107497

Supplementary Protection Certificates for avibactam sodium; aztreonam

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1480644	58/2016	Austria		PRODUCT NAME: KOMBINATION AUS CEFTAZIDIM UND AVIBACTAM; REGISTRATION NO/DATE: EU/1/16/1109 (MITTEILUNG) 20160628
1480644	16C1019	France		PRODUCT NAME: ASSOCIATION OU MELANGE PHARMACEUTIQUE RENFERMANT EN TANT QU'INGREDIENTS ACTIFS:(1) LA CEFTAZIDIME OU UN DES SES SELS ET (2) L'AVIBACTAM OU UN DE SES SELS; REGISTRATION NO/DATE: EU/1/16/1109 20160628
1480644	PA2016037	Lithuania		PRODUCT NAME: CEFTAZIDIMAS + AVIBAKTAMAS; REGISTRATION NO/DATE: EU/1/16/1109/001 20160624
1480644	629	Finland
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	CA 2016 00059	Denmark		PRODUCT NAME: FARMACEUTISK BLANDING ELLER SAMMENSAETNING DER SOM AKTIVE BESTANDDELE DERAF, HERUNDER CEFTAZIDIMPENTAHYDRAT OG AVIBACTAMNATRIUM; REG. NO/DATE: EU/1/16/1109 20160628

Investment Analysis of the Pharmaceutical Drug: Avibactam Sodium and Aztreonam

Last updated: February 3, 2026

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Summary

This report presents a comprehensive analysis of the investment scenario, market dynamics, and financial trajectory related to the combination of Avibactam Sodium and Aztreonam. The partnership targets combating multidrug-resistant Gram-negative bacterial infections. The analysis covers current market positioning, competitive landscape, regulatory developments, revenue projections, and strategic considerations for investors.

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Introduction

The combination of Avibactam Sodium (a non-steroidal beta-lactamase inhibitor) with Aztreonam (a monobactam antibiotic) addresses critical gaps in antimicrobial resistance (AMR). This combination, under clinical development, aims to treat infections caused by resistant Enterobacteriaceae and Pseudomonas aeruginosa strains, especially those producing multiple beta-lactamases.

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Market Overview

Global Antibiotics Market (2023–2030)

Segment	Market Size (USD Billion)	CAGR (2023–2030)	Remarks
Total Antibiotics Market	52.6	3.8%	Driven by AMR, aging populations, and unmet needs
Beta-lactam Antibiotics	22.0	4.2%	Largest segment, including carbapenems, monobactams, and cephalosporins
Novel Antibiotics Market	8.4	12.5%	Includes drug candidates targeting resistant bacteria

Sources: [1], [2]

Key Drivers

• Growing incidence of multidrug-resistant (MDR) infections
• Regulatory incentives for orphan and rare diseases
• Rising government and private investments in antimicrobial R&D
• Limited pipeline of effective antibiotics for resistant strains

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Product Profile

Avibactam Sodium + Aztreonam Combination

• Pharmacological Class:
  • Avibactam: Beta-lactamase inhibitor targeting class A, C, D enzymes
  • Aztreonam: Monobactam antibiotic effective against gram-negative bacteria, stable against metallo-beta-lactamases
• Indications:
  • Hospital-acquired pneumonia
  • complicated urinary tract infections (cUTIs)
  • complicated intra-abdominal infections
  • infections caused by MDR organisms

Development Status

Phase	Status	Expected Approval Timeline	Regulatory Body	Key Partnerships
Phase III (as of 2023)	Ongoing trials, positive data	2024–2025	FDA, EMA	Collaboration with biotech firms

Note: The drug combination leverages the complementary spectrum of aztreonam's stability against metallo-beta-lactamases, with avibactam's beta-lactamase inhibition, filling a treatment gap.

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Market Potential and Revenue Projections

Market Opportunity Drivers

Factor	Impact
Rising MDR bacterial infections	Expanding target patient pool
Limited current effective therapies	High unmet medical need
Regulatory priority for antibacterials	Accelerated approvals and incentives
Market penetration potential in hospitals	Medicare, Medicaid, and private insurer coverages

Revenue Forecast (2023–2032)

Year	Estimated Sales (USD Million)	Growth Rate	Notes
2023	50	-	Early-stage market entry
2024	150	200%	Launch in restricted markets
2026	500	233%	Broader approvals, initial uptake
2028	1,200	140%	Increased adoption in hospitals
2032	3,500	192%	Expected global market penetration

Cumulative 10-year revenue potential: US$21.2 billion, with high growth assumptions contingent on regulatory approval, patent protection, and emergence of resistant strains.

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Market Dynamics

Competitive Landscape

Competitor Name	Product / Candidate	Mechanism of Action	R&D Stage	Strengths	Weaknesses
Merck (Relebactam + Imipenem)	Recarbrio® (Relebactam + Imipenem)	B-lactamase inhibition + carbapenem	Approved	Broad-spectrum activity	Limited effectiveness against certain MBL producers
Basilea Pharma (Imixtam)	Imixtam (aztreonam + avibactam)	Beta-lactamase inhibition + monobactam	Phase III	Focused on resistant gram-negatives	Competition from other combinations
Pfizer (Zemdri)	Plazomicin (aminoglycoside)	Protein synthesis inhibition	Approved	Efficacy in resistant infections	Limited spectrums of activity

Note: The combination of avibactam and aztreonam remains somewhat unique pending regulatory approval, providing a significant competitive edge if successful.

Regulatory & Policy Environment

• FDA Fast Track and Orphan Drug Designation: Accelerate approvals for MDR therapies (2020–2025)
• EMA Priority Medicines (PRIME): Support development of antibiotics targeting MDR bacteria
• Global AMR Action Plan: Urges incentivization for novel antibiotics

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Financial Trajectory & Investment Risks

Risk Factor	Impact	Mitigation Strategies
Clinical trial delays	Revenue delays, increased R&D costs	Early engagement with regulators, adaptive trial designs
Patent expiration	Patent cliffs reducing exclusivity	Filing patents early, pipeline diversification
Regulatory hurdles	Approval delays or denials	Maintain robust clinical data, proactive engagement with authorities
Market competition	Faster entrants reducing market share	Strategic partnerships, licensing agreements

Note: Initial R&D investments are estimated at USD 150–200 million to reach Phase III, with subsequent commercialization costs of approximately USD 300 million.

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Comparison with Similar Partnerships

Parameter	Avibactam + Aztreonam	Relebactam + Imipenem	Meropenem + Nacubactam
Development Stage	Phase III or nearing approval	Approved	Mid-stage development
Spectrum of Activity	Resistant gram-negatives; MBL producers	Broad-spectrum, including carbapenems	Broad-spectrum, some MBL coverage
Market Focus	MDR infections in hospitals	Hospital-acquired infections	Nosocomial pneumonia
Strategic Play	Filling unmet niche in resistant Gram-negatives	Competing with existing therapies	Similar, but with broader spectrum

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Key Considerations for Investors

• Market Timing: Rapidly evolving antimicrobial landscape necessitates swift development and regulatory approval.
• Patent & Exclusivity: Ensure strong patent positions to prevent generic competition.
• Partnerships & Collaborations: Leverage alliances with biotech firms, government agencies, and hospital networks.
• Regulatory Landscape: Proactive engagement with agencies enhances approval prospects.
• Pricing & Reimbursement: Critical for profitability given hospital-based market focus.

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Key Takeaways

• The combination of Avibactam Sodium and Aztreonam addresses significant unmet needs in resistant bacterial infections, notably MBL producers.
• The market potential is substantial, with forecasts exceeding USD 3.5 billion annually by 2032, driven by global AMR challenges.
• Competitive position hinges upon successful progression through clinical phases and regulatory approvals; current competitors are still in development or limited approval.
• Investment opportunities are promising but pose risks related to clinical, regulatory, and market factors; early-stage investors should prioritize due diligence.
• Policy and incentives are aligned to accelerate development, but navigating complex regulatory pathways requires strategic planning.

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FAQs

Q1: What are the main advantages of the avibactam and aztreonam combination over existing antibiotics?
Answer: It uniquely targets resistant bacteria producing metallo-beta-lactamases (MBLs), which are resistant to many current beta-lactam antibiotics. By combining aztreonam (stable against MBLs) with avibactam (broad beta-lactamase inhibitor), this combo offers an effective solution where others fail.

Q2: What is the current regulatory status of this drug combination?
Answer: As of 2023, the combination is in Phase III clinical trials, with promising data suggesting nearing regulatory submissions in major markets like the US and EU. The developers are engaged with agencies for expedited review pathways.

Q3: Which markets present the highest revenue opportunities?
Answer: The US and Europe are primary markets owing to advanced healthcare infrastructure; emerging markets in Asia-Pacific and Latin America also reflect growth potential due to rising resistance rates.

Q4: What are the primary risks affecting the investment outlook?
Answer: Risks include clinical trial delays, regulatory hurdles, patent challenges, and aggressive competition. Market penetration depends heavily on pricing, reimbursement, and physician adoption.

Q5: How does antimicrobial resistance influence the financial trajectory of this drug?
Answer: Rising MDR infection rates expand the potential patient population, increasing market size. However, rapid evolution of resistance patterns requires continuous surveillance to sustain market relevance.

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References

[1] ResearchandMarkets. "Global Antibiotics Market (2023–2030)". April 2023.
[2] IQVIA. "The Global Antimicrobial Resistance Market." 2022.
[3] U.S. Food and Drug Administration. "Fast Track Designation for Antibiotics." 2021.
[4] European Medicines Agency. "PRIME Scheme for Antibiotics." 2022.

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Note: This analysis is meant to inform strategic investment decisions, emphasizing current data and projected trends based on market reports, clinical developments, and regulatory policies.