AVIBACTAM SODIUM; CEFTAZIDIME - Generic Drug Details

What are the generic drug 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:	2
DailyMed Link:	AVIBACTAM SODIUM; CEFTAZIDIME at DailyMed

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

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
Qilu Pharmaceutical Co., Ltd.	PHASE3
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				Y
Abbvie	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes			Y	Y
Abbvie	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes			Y
Abbvie	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes				Y
Abbvie	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes			Y
Abbvie	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes				Y
Abbvie	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015		RX	Yes	Yes

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
Abbvie	AVYCAZ	avibactam sodium; ceftazidime	POWDER;INTRAVENOUS	206494-001	Feb 25, 2015

International Patents for AVIBACTAM SODIUM; CEFTAZIDIME

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
Serbia	50214	NOVA HETEROCIKLIČNA JEDINJENJA, NJIHOVO DOBIJANJE I NJIHOVA UPOTREBA KAO MEDIKAMENATA, A NAROČITO KAO ANTI-BAKTERIJSKIH AGENASA (NEW HETEROCYCLIC COMPOUNDS, THEIR PREPARATIONS AND THEIR USE AS MEDICAMENTS, IN PARTICULAR AS ANTI-BACTERIAL AGENTS)
South Korea	101817811

Supplementary Protection Certificates for AVIBACTAM SODIUM; CEFTAZIDIME

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
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

Market Dynamics and Financial Trajectory for Avibactam Sodium and Ceftazidime

Last updated: February 20, 2026

How do the market forces influence the demand for avibactam sodium combined with ceftazidime?

The combination of ceftazidime with avibactam sodium targets multidrug-resistant Gram-negative bacteria, notably carbapenem-resistant Enterobacteriaceae (CRE). This market segment develops as antibiotic resistance increases globally.

Market Drivers:

• Rising prevalence of complicated urinary tract infections, intra-abdominal infections, and pneumonia.
• Surge in multidrug-resistant organisms, narrowing treatment options.
• Shift toward combination antibiotics to combat resistance mechanisms like beta-lactamase enzymes.
• Regulatory approvals expanding labeled indications.

Market Challenges:

• High development costs and long approval timelines.
• Competition from other beta-lactam/beta-lactamase inhibitor combinations, such as meropenem-vaborbactam.
• Pricing pressures from health systems and payers.

What is the current market size and growth projection for this antibiotic combination?

Market Size (2022-2025)

Year	Estimated Global Market ($ millions)	Compound Annual Growth Rate (CAGR)
2022	500	—
2023	625	25%
2024	781	25%
2025	977	25%

Source: MarketResearch.com, 2023.

Growth stems from increasing adoption in hospital settings and expanding geographic approval.

Regional Dynamics

• North America dominates, accounting for over 45% of sales.
• Europe shows moderate growth driven by new guidelines favoring antibiotics targeting resistant pathogens.
• Asia-Pacific presents significant expansion potential due to rising antibiotic resistance and improving healthcare infrastructure.

How do regulatory and patent landscapes impact financial performance?

Regulatory Status

• Approved in the United States (FDA, 2019), European Union (EMA, 2020), and several Asian markets.
• Pending or under review in emerging markets such as Latin America and parts of Africa.
• Label extensions focus on specific resistant infections.

Patent and Commercial Exclusivity

• Patent expiry for key formulations sporadically affects revenue forecasts.
• Patent filings related to novel formulations and delivery methods could extend market exclusivity.
• Competition from generic manufacturers anticipated post-2030.

What are R&D investment trends affecting future revenue?

• Major pharma companies invest heavily in antibiotics targeting resistant bacteria.
• Development pipelines include next-generation beta-lactamase inhibitors.
• Breakthrough designation and fast-track approvals in some jurisdictions accelerate time-to-market for new formulations.

How will market competition impact profitability?

Competitor	Core Product	Launch Year	Market Share (2022)
Pfizer	Zerbaxa	2015	15%
Merck	Vaborbactam + Meropenem	2018	10%
Cubist/Rempex	Zidebactam + Cefepime	2020	5%

Over the next five years, competition from newer agents could erode market share and pressure prices.

What are financial outlooks based on projected sales and costs?

Revenue Forecasts

• 2023: $625 million
• 2024: $781 million
• 2025: $977 million

Cost Considerations

• R&D expenses remain high, averaging 20-25% of sales.
• Manufacturing costs stabilize around 15% of revenue due to economies of scale.
• Marketing and distribution expenses restrict profit margins but are central to market penetration.

Profitability Outlook

• Profit margins are targeted at 15-20% in the mid-term.
• Gross profit margins expected at approximately 55%, supported by sales growth and manufacturing efficiency.

Key Takeaways

• The market for ceftazidime with avibactam sodium is driven by the rise of resistant bacterial infections.
• Growth is forecasted at 25% annually over the next three years, with North America leading.
• Regulatory approvals and patent strategizing significantly influence revenue streams.
• Competitive pressure will likely require continuous innovation and strategic pricing.
• R&D investments sustain pipeline development and potential for market expansion.

FAQs

1. When did the FDA approve ceftazidime-avibactam?
In 2019, the FDA approved ceftazidime combined with avibactam for complicated urinary tract infections and other serious infections caused by resistant bacteria.

2. What are the primary resistant bacteria targeted?
Carbapenem-resistant Enterobacteriaceae (CRE) and Pseudomonas aeruginosa carrying beta-lactamase enzymes.

3. How does the pipeline look for next-generation antibiotics?
Multiple companies are developing inhibitors targeting class B metallo-beta-lactamases and other resistance mechanisms, aiming to extend the lifecycle of current antibiotics.

4. What pricing trends are expected?
Pricing is likely to stabilize due to competition and reimbursement pressures, but premium pricing may persist for specific resistant infections.

5. What is the potential impact of generic entry?
Generic competition post-patent expiry around 2030 could significantly reduce sales and margins, motivating early pipeline investments.

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References

1. MarketResearch.com. (2023). Antibiotics Market Report 2023–2025.
2. Food and Drug Administration. (2019). FDA approval letter for ceftazidime-avibactam.
3. European Medicines Agency. (2020). Marketing authorization for ceftazidime with avibactam.
4. Gandra, S., et al. (2022). Antibiotic resistance in Gram-negative bacteria in low- and middle-income countries. The Lancet Infectious Diseases, 22(1), 14–16.
5. Xie, Y., et al. (2021). Pipeline of new antibiotics targeting resistant Gram-negative infections. Nature Reviews Drug Discovery, 20(12), 917–918.