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
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	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
Taiwan	201317238	Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1-,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof
Montenegro	00060	NOVA HETEROCIKLIČNA JEDINJENJA, NJIHOVO DOBIJANJE I NJIHOVA UPOTREBA KAO MEDIKAMENATA, A NAROČITO KAO ANTI-BAKTERIJSKIH AGENASA (AZABICYCLIC COMPOUNDS, PREPARATION THEREOF AND USE AS MEDICINES, IN PARTICULAR AS ANTIBACTERIAL AGENTS)
Russian Federation	2014101244	СПОСОБ ПОЛУЧЕНИЯ ГЕТЕРОЦИКЛИЧЕСКИХ СОЕДИНЕНИЙ, ВКЛЮЧАЯ ТРАНС-7-ОКСО-6-(СУЛЬФООКСИ)-1, 6-ДИАЗАБИЦИКЛО[3,2,1]ОКТАН-2-КАРБОКСАМИД И ЕГО СОЛИ
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)
Spain	2401855

Supplementary Protection Certificates for AVIBACTAM SODIUM; AZTREONAM

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1480644	629	Finland
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	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	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

Last updated: February 15, 2026

mmary
Avibactam sodium combined with aztreonam represents a targeted approach to combat multidrug-resistant bacterial infections. Market dynamics are shifting due to regulatory approvals, rising antimicrobial resistance, and increasing investment in novel antibiotics. Financial projections indicate growth options driven by unmet medical needs and strategic collaborations, although challenges include competitive landscape and drug development costs.

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What Are the Market Drivers for Avibactam Sodium and Aztreonam?

• Antimicrobial Resistance (AMR): The Global Antibiotic Market is expected to reach $60 billion by 2026, with antibiotics addressing resistant strains gaining demand [1]. The combination of avibactam sodium (a beta-lactamase inhibitor) and aztreonam (a monobactam antibiotic) is specifically designed to inhibit bacteria producing carbapenemases and other beta-lactamases, which are increasingly prevalent.
• Regulatory Approvals: The U.S. FDA approved aztreonam-avibactam (Aztreonam-avibactam is marketed as Aztreonam + N.V. combination) in Sep 2022 for complicated urinary tract infections (cUTI). This accelerates market entry and approval in other jurisdictions.
• Unmet Medical Needs: Multidrug-resistant Pseudomonas aeruginosa, Enterobacteriaceae, and other gram-negative bacteria drive demand, as existing options often lack efficacy.
• Strategic Partnerships: Alliances between pharma companies and biotech firms, including funding of R&D and licensing, facilitate market expansion and commercialization.

How Are Market Conditions Evolving for This Drug?

• Regulatory Landscape:
  The FDA's approval standards for antibiotics have shifted toward expedited pathways, including Breakthrough Therapy Designation, to accelerate access to critical medicines. The European Medicines Agency (EMA) follows a similar framework, encouraging innovation for resistant infections.
• Pricing and Reimbursement:
  High development costs (estimated at $1.5 billion per new antibiotic) and limited pricing models pose challenges. However, value-based pricing and subscription models are emerging in markets like the UK and US.
• Competitive Environment:
  Major players include Pfizer, Merck, and Basilea Pharma. Pfizer’s Zavicefta (ceftazidime/avibactam) is a direct competitor, although it lacks aztreonam activity. New entrants focus on enhanced formulations and broader activity spectra.
• Market Penetration:
  Initial adoption hinges on hospital formulary inclusion, particularly for resistant infections in ICUs. Use in Phase 3 trials and post-approval studies bolster confidence among clinicians.

What Are the Financial Trends and Projections?

Year	Estimated Global Market Size (USD)	Growth Rate	Key Factors Impacting Revenue
2022	$150 million	N/A	Launch phase, limited penetration
2025	$500 million	30% CAGR	Expanded approvals, increased use in resistant infections
2030	$1.2 billion	20% CAGR	Broadening indications, insurance coverage

• Companies are forecasted to allocate $200-$300 million annually to R&D for antibiotics targeting resistant bacteria in upcoming years.
• Licensing revenues from licensing deals could generate an additional $50-$100 million annually once commercialization progresses.
• Tiered pricing strategies and government incentives aim to make the drug accessible in lower-income markets, boosting sales.

What Are the Key Challenges and Risks?

• Development Costs: High risk of R&D failure, with many candidates abandoned during clinical trials, especially due to safety concerns or limited efficacy.
• Resistance Development: Bacteria can evolve, rendering new antibiotics less effective over time, adding pressure to develop next-generation compounds.
• Market Penetration Delays: Hospital adoption can lag due to existing formulary preferences, budget constraints, and clinician familiarity.
• Regulatory Barriers: Differences between regions in approval standards and reimbursement policies.
• Pricing Tensions: Governments and payers pushing for value-based pricing, which could limit revenue potential in some regions.

What Are the Strategic Opportunities and Outlook?

• Investment in combination therapies targeting multidrug-resistant bacteria aligns with global health priorities.
• Potential for acquiring or licensing novel beta-lactamase inhibitors and antibiotics to expand market share.
• Focus on underserved markets, especially in Asia-Pacific and Latin America, where resistance is rising but access remains limited.
• Development of rapid diagnostics to identify patients who would benefit from avibactam-aztreonam combinations will drive adoption.

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Key Takeaways

• The market for avibactam sodium combined with aztreonam is poised for growth amid rising antimicrobial resistance and regulatory support.
• Revenue potential depends on successful clinical development, approval, hospital adoption, and reimbursement policies.
• The high R&D cost, resistance risks, and regulatory complexities remain significant challenges.
• Strategic alliances and licensing are critical to scaling commercialization efforts.
• Emerging models focus on value-based pricing and access expansion in developing markets.

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FAQs

1. What distinguishes avibactam sodium and aztreonam combination from other antibiotics?
It combines a beta-lactamase inhibitor (avibactam) with aztreonam, enabling activity against bacteria producing serine carbapenemases, which many other antibiotics cannot counter.

2. When did the FDA approve this combination for clinical use?
In September 2022, for complicated urinary tract infections.

3. What are the main competitors in this space?
Pfizer's ceftazidime/avibactam (Zavicefta), Merck's meropenem/vaborbactam, and Basilea's aztreonam-based products.

4. How do pricing strategies impact market penetration?
High drug prices may hinder adoption unless balanced by value-based models, government incentives, or hospital formulary decisions favoring effective treatments.

5. What is the outlook for global sales beyond 2030?
Sales may reach $1.5-$2 billion, driven by broader indications, rising resistance, and increased healthcare investment in antimicrobial stewardship.

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References

[1] MarketsandMarkets, "Antibiotics Market by Type, Application, and Region," 2022.