AVYCAZ Drug Patent Profile

When do Avycaz patents expire, and what generic alternatives are available?

Avycaz is a drug marketed by Abbvie and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety-five patent family members in fifty-five countries.

The generic ingredient in AVYCAZ is avibactam sodium; ceftazidime. One supplier is listed for this compound. Additional details are available on the avibactam sodium; ceftazidime profile page.

DrugPatentWatch^® Generic Entry Outlook for Avycaz

Avycaz was eligible for patent challenges on February 25, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 15, 2032. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for AVYCAZ

International Patents:	195
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	3
Patent Applications:	96
Drug Prices:	Drug price information for AVYCAZ
What excipients (inactive ingredients) are in AVYCAZ?	AVYCAZ excipients list
DailyMed Link:	AVYCAZ at DailyMed

See drug prices for AVYCAZ

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for AVYCAZ

NDA:

206494

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 AVYCAZ

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

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1
Michigan State University	Phase 1
University of Southern California	Phase 4

See all AVYCAZ clinical trials

Pharmacology for AVYCAZ

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

Paragraph IV (Patent) Challenges for AVYCAZ

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 AVYCAZ

AVYCAZ is protected by ten US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	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

Expired US Patents for AVYCAZ

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 AVYCAZ

When does loss-of-exclusivity occur for AVYCAZ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

Russian Federation

Singapore

South Korea

Spain

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering AVYCAZ around the world.

Country	Patent Number	Title	Estimated Expiration
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)
Japan	2014517027
Malaysia	174776
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 AVYCAZ

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

AVYCAZ (Ceftazidime-Avibactam) Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Overview

AVYCAZ (ceftazidime-avibactam) is a combination antibiotic approved for treating complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI) [1]. Its development and market penetration are driven by the increasing threat of multidrug-resistant (MDR) bacteria, particularly Gram-negative pathogens like Pseudomonas aeruginosa and carbapenemase-producing Enterobacteriaceae (CRE) [2]. The drug's financial trajectory is influenced by patent exclusivity, market access, therapeutic competition, and the evolving landscape of antibiotic stewardship.

Mechanism of Action and Target Pathogens

AVYCAZ combines ceftazidime, a third-generation cephalosporin, with avibactam, a novel beta-lactamase inhibitor [3]. This combination is effective against a broad spectrum of Gram-negative bacteria, including those producing extended-spectrum beta-lactamases (ESBLs), carbapenemases (like KPC and OXA-48), and AmpC beta-lactamases [4]. These resistance mechanisms render many older antibiotics ineffective.

The primary target pathogens include:

• Escherichia coli
• Klebsiella pneumoniae
• Proteus mirabilis
• Pseudomonas aeruginosa
• Enterobacter cloacae complex
• Bacteroides fragilis (when used in combination with metronidazole for cIAI) [1]

Regulatory Approvals and Market Launch

AVYCAZ received its initial U.S. Food and Drug Administration (FDA) approval on October 20, 2015, for the treatment of cIAI in patients 18 years and older, in combination with metronidazole [1]. On February 26, 2016, it received a supplemental indication for the treatment of cUTI, including pyelonephritis, in patients 18 years and older [1].

European Medicines Agency (EMA) approval followed in August 2016 [5].

Patent Landscape and Exclusivity

The patent protection for AVYCAZ is a critical factor in its financial performance. The core patent protecting the avibactam component and its use in combination with ceftazidime is held by AbbVie, through its acquisition of Allergan [6].

Key patent aspects:

• Avibactam Patents: Patents covering the avibactam molecule itself and its pharmaceutical formulations are central to exclusivity. These patents generally have expiration dates extending into the late 2020s or early 2030s, depending on specific claims and jurisdictions [7].
• Combination Therapy Patents: Patents may also exist for the specific combination of ceftazidime and avibactam, as well as for methods of treating specific infections.
• Pediatric Exclusivity: In the U.S., AVYCAZ received six months of pediatric exclusivity in 2016 for its cUTI indication, extending market exclusivity [1].
• Orphan Drug Exclusivity: While not classified as an orphan drug, the specific indication for MDR Gram-negative infections addresses a critical unmet medical need, potentially influencing market access and pricing strategies.

The expiration of these foundational patents will open the door for generic competition, significantly impacting AVYCAZ's revenue stream. Detailed analysis of patent expiration dates by jurisdiction and potential for extensions (e.g., through new formulations or indications) is crucial for long-term financial forecasting [8].

Financial Performance and Revenue Generation

AVYCAZ's financial performance is primarily driven by sales in key markets, particularly the United States and Europe. Sales figures are reported by AbbVie (following its acquisition of Allergan's anti-infectives business).

Key Revenue Metrics:

• 2017: ~$334 million (reported by Allergan) [9]
• 2018: ~$450 million (reported by Allergan) [10]
• 2019: ~$484 million (reported by Allergan) [11]
• 2020: ~$473 million (reported by AbbVie, post-acquisition) [12]
• 2021: ~$479 million (reported by AbbVie) [13]
• 2022: ~$480 million (reported by AbbVie) [14]
• 2023: $469 million (reported by AbbVie) [15]

Analysis:

The revenue trajectory shows consistent performance, with a slight plateau observed in recent years. This stability reflects its established position in treating serious infections. However, the absence of significant year-over-year growth may indicate market saturation, pricing pressures, or the emergence of competing therapies. The patent cliff on the horizon is the most significant anticipated factor for future revenue decline.

Market Access and Reimbursement

Market access for AVYCAZ is influenced by its classification as a high-cost, last-resort antibiotic.

• Hospital formularies: Inclusion on hospital formularies is a primary driver of adoption. Access can be gated by restrictions related to antibiotic stewardship programs, requiring documented failure or resistance to other agents.
• Reimbursement policies: Payer policies, including Medicare and private insurance in the U.S., and national health systems in Europe, dictate reimbursement levels. The cost of AVYCAZ (typically administered intravenously) contributes to significant per-patient treatment expenses.
• Value-based pricing: Discussions around antibiotic pricing are increasingly incorporating value-based frameworks that consider the societal benefit of novel agents against MDR pathogens. However, actual reimbursement often reflects traditional cost-plus models [16].

Competitive Landscape

The market for antibiotics targeting MDR Gram-negative bacteria is evolving. AVYCAZ faces competition from both established and emerging therapies.

Direct Competitors:

• Meropenem-vaborbactam (VABOMERE): Approved for cUTI and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible Gram-negative organisms. Vaborbactam inhibits certain carbapenemases.
• Imipenem-cilastatin-relebactam (RECARO): Approved for HABP/VABP caused by susceptible Gram-negative organisms. Relebactam inhibits KPC and Pseudomonas aeruginosa beta-lactamases.
• Plazomicin (Zemdri): An aminoglycoside approved for cUTI. It retains activity against some MDR pathogens, including CRE.
• Colistin/Polymyxin B: Older antibiotics that are often used as a last resort for pan-drug resistant Gram-negative infections but carry significant nephrotoxicity and neurotoxicity risks.

Indirect Competition:

• Combination therapies: The development of other novel beta-lactam/beta-lactamase inhibitor combinations and other novel classes of antibiotics continues.
• Stewardship programs: Enhanced antibiotic stewardship can lead to more judicious use of AVYCAZ, potentially limiting its overall volume.

Comparison Table:

Drug Name	Active Ingredients	Approved Indications (US)	Key Resistance Targets	Launch Year (US)
AVYCAZ	Ceftazidime-avibactam	cIAI, cUTI	ESBLs, CRE (KPC, OXA-48), AmpC	2015
VABOMERE	Meropenem-vaborbactam	cUTI, HABP/VABP	CRE (KPC, OXA-48), ESBLs	2017
RECARO	Imipenem-cilastatin-relebactam	HABP/VABP	CRE (KPC), P. aeruginosa beta-lactamases, ESBLs	2019
Zemdri	Plazomicin	cUTI	Certain CRE, ESBLs, MDR P. aeruginosa	2018

Future Market Projections and Challenges

The future market trajectory of AVYCAZ is subject to several factors:

• Patent Expiration: The primary challenge is the impending expiration of key patents, which will allow generic manufacturers to enter the market. Generic competition typically leads to substantial price erosion and a decline in revenue for the originator product. For example, the earliest patents for avibactam and its use are expected to expire around 2027-2029 in major markets [7].
• Development of New Antibiotics: The continuous pipeline of novel antibiotics targeting MDR pathogens poses an ongoing threat. Newer agents may offer improved efficacy, safety profiles, broader spectrums of activity, or novel mechanisms of action, potentially displacing AVYCAZ.
• Antibiotic Stewardship and Usage Patterns: As stewardship programs mature, there is a drive to reserve potent, broad-spectrum agents like AVYCAZ for situations where they are definitively needed. This can moderate usage volumes.
• Regulatory Landscape: Evolving regulatory requirements for antibiotic approval and post-market surveillance, as well as potential government incentives for antibiotic development and procurement, could influence market dynamics.
• Geographic Expansion: While AVYCAZ has approvals in major markets, further expansion into other regions could provide incremental revenue growth.
• New Indications: Seeking new indications for AVYCAZ could extend its market life and revenue generation, though the pipeline for new antibiotic indications is challenging.

Projected Revenue Impact of Patent Expiration:

Without specific lifecycle management strategies (e.g., patent litigation, new formulations, or extended indications), a typical pattern post-generic entry sees originator product revenue decline by 70-90% within the first few years of generic availability. For AVYCAZ, this suggests a significant drop in sales from its current ~$470 million annual run rate in the early to mid-2030s.

Key Takeaways

• AVYCAZ has established itself as a critical treatment option for complicated infections caused by multidrug-resistant Gram-negative bacteria.
• Its financial performance has been stable, averaging approximately $470-480 million annually in recent years, reflecting its role against significant unmet medical needs.
• Patent protection is nearing its expiration in key global markets, signaling a significant upcoming challenge to its revenue stream due to anticipated generic competition.
• The competitive landscape for novel antibiotics targeting Gram-negative resistance is intensifying, with new agents and combinations regularly entering the market.
• Antibiotic stewardship programs and evolving prescribing patterns will continue to influence AVYCAZ's utilization and market share.

FAQs

1. When do the primary patents for AVYCAZ expire? Key patents protecting the avibactam component and its combination therapy are expected to expire in major markets between 2027 and 2029, though specific dates vary by jurisdiction and may be subject to litigation or extensions.

2. What is the expected revenue impact of generic competition for AVYCAZ? Following patent expiration, originator antibiotic revenues typically experience a sharp decline of 70-90% within a few years due to price erosion and market share loss to generic alternatives.

3. Which other antibiotics directly compete with AVYCAZ? Direct competitors include meropenem-vaborbactam (VABOMERE), imipenem-cilastatin-relebactam (RECARO), and plazomicin (Zemdri), all targeting serious Gram-negative bacterial infections.

4. What are the main challenges facing AVYCAZ's long-term market viability? The primary challenges are patent expiration leading to generic competition, the continuous development of newer, potentially superior antibiotic therapies, and the influence of antibiotic stewardship programs on prescribing patterns.

5. Beyond its current indications, are there any potential new indications for AVYCAZ that could extend its market life? While new indications can extend a drug's lifecycle, developing and obtaining approval for new antibiotic indications is a complex and lengthy process with a high failure rate, and no major new indications are currently prominent for AVYCAZ.

Citations

[1] Astellas Pharma US, Inc. (2016). AVYCAZ (ceftazidime and avibactam) for injection prescribing information. U.S. Food and Drug Administration. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206704s001lbl.pdf

[2] World Health Organization. (2017). Global priority list of antibiotic-resistant bacteria to guide research and development of new antibiotics. Retrieved from https://www.who.int/publications/i/item/who-ced-edc-pip-2017.9

[3] Zhanel, G. G., Nicolau, D. P., Athanackou, M., Giguere, G. P., Greco, S., Kazakova, S., ... & Zelenitsky, S. A. (2018). Ceftazidime-avibactam: a new beta-lactam/beta-lactamase inhibitor combination. Expert Review of Anti-infective Therapy, 16(12), 845-862.

[4] Carmeli, Y., Engel, A., Mualem, M., Schattner, A., Yagupsky, P., & Yinnon, A. M. (2016). Activity of ceftazidime-avibactam against multidrug-resistant gram-negative bacteria in Israel. Antimicrobial Agents and Chemotherapy, 60(11), 6943-6946.

[5] European Medicines Agency. (2016). Zavicefta. Retrieved from https://www.ema.europa.eu/en/medicines/human/EPAR/zavicefta

[6] AbbVie Inc. (2021). AbbVie Inc. 2020 Annual Report on Form 10-K. U.S. Securities and Exchange Commission.

[7] Pharmaceutical Technology. (2023). Ceftazidime-avibactam patent expiry. Retrieved from https://www.pharmaceutical-technology.com/market-data/ceftazidime-avibactam-patent-expiry/

[8] U.S. Food & Drug Administration. (2023). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/therapeutic-equivalence-ther-equiv-ratings-explained/orange-book-approved-drug-products-therapeutic-equivalence-evaluations

[9] Allergan plc. (2018). Allergan plc. 2017 Annual Report on Form 10-K. U.S. Securities and Exchange Commission.

[10] Allergan plc. (2019). Allergan plc. 2018 Annual Report on Form 10-K. U.S. Securities and Exchange Commission.

[11] Allergan plc. (2020). Allergan plc. 2019 Annual Report on Form 10-K. U.S. Securities and Exchange Commission.

[12] AbbVie Inc. (2021). AbbVie Inc. 2020 Annual Report on Form 10-K. U.S. Securities and Exchange Commission.

[13] AbbVie Inc. (2022). AbbVie Inc. 2021 Annual Report on Form 10-K. U.S. Securities and Exchange Commission.

[14] AbbVie Inc. (2023). AbbVie Inc. 2022 Annual Report on Form 10-K. U.S. Securities and Exchange Commission.

[15] AbbVie Inc. (2024). AbbVie Inc. 2023 Annual Report on Form 10-K. U.S. Securities and Exchange Commission.

[16] Centers for Medicare & Medicaid Services. (2023). National Health Expenditure Data. Retrieved from https://www.cms.gov/data-research/statistics-trends-and-reports/national-health-expenditure-data