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 have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

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
Drug Prices:	Drug price information for AVYCAZ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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
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
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 AVYCAZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1480644	300847	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
1480644	PA2016037	Lithuania		PRODUCT NAME: CEFTAZIDIMAS + AVIBAKTAMAS; 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
1480644	C20160041 00213	Estonia		PRODUCT NAME: TSEFTASIDIIM/AVIBAKTAAM;REG NO/DATE: EU/1/16/1109 28.06.2016
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	122016000105	Germany		PRODUCT NAME: CEFTAZIDIM ODER EIN SALZ DAVON MIT AVIBACTAM ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/16/1109 20160624

Last updated: July 22, 2026

AVYCAZ market dynamics and financial trajectory (2019–2024): pricing, volume, and exclusivity-driven risk

AVYCAZ (ceftazidime-avibactam) is a specialty IV antibiotic sold in the US as a broad-reimbursement hospital drug, with demand shaped by hospital antibiogram dynamics, formulary status, CDI and CRE containment protocols, and competitive substitution versus meropenem-vaborbactam (Vabomere) and imipenem-cilastatin-relebactam (Recarbrio), plus newer cephalosporin combinations entering later. Financially, the brand’s trajectory has remained tightly linked to US hospital contracting cycles and loss/gain of managed-care coverage, with patent and exclusivity milestones constraining generic and biosimilar risk. The company’s reported net sales pattern indicates a maturing product cycle with incremental growth mostly dependent on penetration for targeted Gram-negative threats (notably resistant Pseudomonas aeruginosa and Enterobacterales) rather than large sustained expansion.

What drives AVYCAZ hospital demand and market share?

AVYCAZ is used primarily in inpatient settings for complicated intra-abdominal infections, complicated urinary tract infections, hospital-acquired bacterial pneumonia including ventilator-associated bacterial pneumonia, and for resistant Gram-negative pathogens within the scope of its labeled indications and hospital stewardship pathways. Demand is typically driven by (1) resistant organism pressure, (2) guideline alignment and local antibiogram trends, (3) stewardship approval pathways for cephalosporin-avibactam use, (4) formulary contracting and pharmacy benefit manager (PBM) positioning, and (5) clinician familiarity and dosing convenience relative to alternative β-lactam/combination regimens.

How do stewardship rules and antibiograms affect AVYCAZ volume?

Hospitals treat AVYCAZ as a targeted therapy for multi-drug resistant Gram-negative infections. In practice, volume lift comes from shifts in local susceptibility patterns that increase the relative probability that empiric or definitive therapy includes an avibactam-containing ceftazidime regimen. Resistance trends affect:

• Share of therapy for CRE-prone patient cohorts.
• Treatment duration mix (shorter courses reduce unit demand even if patient counts remain steady).
• De-escalation behavior after culture results.

What competitive forces pressure AVYCAZ?

AVYCAZ competes in the US in a narrow but high-acuity segment: carbapenem-sparing and β-lactam/β-lactamase inhibitor strategies. Key competitive pressure points:

• Substitution by meropenem-vaborbactam (Vabomere) and imipenem-cilastatin-relebactam (Recarbrio) when stewardship protocols prioritize those options for specific β-lactamase phenotypes.
• Local contracting: a hospital may prefer one “relebactam” option across service lines for procurement and order management.
• Patient and microbiology eligibility: clinician selection depends on confirmed or suspected enzyme class.

Why do formularies and contracting cycles matter?

In specialty hospital brands, net sales are sensitive to quarterly and semiannual formulary updates. Contracting dynamics influence:

• Pharmacy spend allocations within hospital systems.
• Usage management rules for restricted antibiotic categories.
• Price net of rebates and credits, which often diverges from list price in US reporting.

How does AVYCAZ pricing and net price trajectory typically evolve?

AVYCAZ pricing is shaped by US hospital acquisition channels, managed rebates, and competitive price pressure. For mature antibiotics, the pattern usually stabilizes around negotiated net pricing while gross-to-net declines can occur if competitors run more aggressive contracting or if payers demand higher rebates to maintain preferred status.

What does “net sales” usually reflect for AVYCAZ?

US branded antibiotic net sales reflect:

• Units dispensed under contracted rates.
• Net price after rebates, chargebacks, and prompt-pay programs.
• Mix shifts across institutions and care settings.

For business planning, the leading indicators are:

• Total vials and days of therapy at covered hospitals.
• New formulary wins or stewardship protocol approvals.
• Competitive displacement in restricted-to-restricted switching.

When does AVYCAZ lose exclusivity in the US, and what does that mean for generics?

AVYCAZ’s generic risk is governed by regulatory exclusivity (data exclusivity, patent protections) and potential Paragraph IV pathways. For a hospital antibiotic brand with multiple patents, the key issue is not a single patent date but the “blocking” set in the Orange Book that a generic must navigate to launch at-risk.

What protects AVYCAZ from generic entry?

Patent estates for combination antibiotics typically include:

• Active ingredient and composition-of-matter.
• Formulations and crystallinity or salt forms.
• Method-of-use claims aligned to labeled indications or specific therapeutic uses.
• Manufacturing and process claims.

How do patent-for-patent blocking sets translate into launch timing?

A generic filing can still be blocked for years if any Orange Book-listed patent remains unexpired or not successfully challenged. Market impact depends on:

• Whether an abbreviated new drug application can be approved before patent expiry.
• Whether settlements restrict launch dates beyond statutory requirements.
• Whether one or more patents cover the route, dosage form, or method that must match the reference product label.

What patents protect AVYCAZ, and how strong is the patent estate?

A complete patent landscape requires the Orange Book listing for AVYCAZ and the underlying patent family details. Without specific patent numbers and listed expiry dates, a reliable strength assessment cannot be produced to the standard needed for licensing and litigation planning.

What is the Orange Book status of AVYCAZ (listed patents, expiry, and exclusivity)?

A complete Orange Book status requires the exact set of listed patents and exclusivity codes tied to AVYCAZ’s approved drug products. Without that listing, producing an accurate “expires on” timeline and identifying blocking patents is not possible.

Has AVYCAZ faced Paragraph IV challenges, and what settlements exist?

Paragraph IV litigation history must be mapped to:

• Case docket and filing date.
• Asserted Orange Book patents.
• Stated or court-ordered settlement terms (launch dates, non-infringement positions, exclusivity carve-outs).
• Any agreement terms tied to specific NDCs or strengths.

Without case identifiers and settlement terms, the litigation risk profile cannot be stated.

How does AVYCAZ compare with Vabomere (meropenem-vaborbactam) and Recarbrio (imipenem-cilastatin-relebactam) on market dynamics?

Competitive positioning: enzyme coverage and stewardship fit

Clinicians often select based on likely resistance mechanism, prior antimicrobial exposure, and culture evidence. AVYCAZ is positioned as a β-lactam/β-lactamase inhibitor option with avibactam activity profile, while Vabomere and Recarbrio are each optimized for their own inhibitor-enzyme coverage. In formulary decisions, procurement preferences can shift the share-of-use even when microbiology overlap exists.

Channel and contracting differences

In hospital purchasing:

• One preferred agent can carry standardized ordering protocols.
• Alternate agents are used for microbiology-driven exception approvals.
• Contract terms can require use quotas or rebate thresholds.

These factors can cause AVYCAZ unit volume to rise in certain hospital systems while falling in others even if national resistant organism trends are stable.

What biosimilar or biologic risk exists for AVYCAZ?

AVYCAZ is a small-molecule antibiotic combination product. Biosimilar pathways do not apply. Competitive generic substitution and label-based regulatory pathways are the relevant risk drivers.

How are AVYCAZ formulation and method-of-use patents used in enforcement?

For antibiotics, enforcement often targets:

• Formulations: solid-state properties, stability, and excipient packages.
• Methods of use: claim scope tied to labeled infections and patient populations.
• Manufacturing: process steps that are difficult to replicate without infringement.

These can delay generic approvals even if a generic can match the active ingredient strength, because it must also satisfy claim scope tied to dosage form and intended use.

What FDA regulatory milestones and label scope affect AVYCAZ sales?

Sales growth is sensitive to label breadth and guideline uptake. For antibiotics, the critical regulatory-commercial link is whether new indications or broadened use patterns lead to increased prescribing across hospital services. Constraining factors include:

• Whether endpoints align with typical inpatient practice settings.
• Whether additional indications require stewardship pathways that slow adoption.
• Whether competing agents cover overlapping patient segments more fully within local guidelines.

Financial trajectory: how has AVYCAZ performed and what is the revenue exposure profile?

A proper financial trajectory analysis requires product-level net sales disclosures by the marketing authorization holder and segmentation by geography and customer type. Without company filings and the exact AVYCAZ revenue series, a data-backed forecast and historical trend cannot be produced to a litigation-grade standard.

Key scenario planning: what generic entry risks exist for AVYCAZ?

The generic entry risk for AVYCAZ depends on:

• The number and expiry timing of listed patents.
• Whether generics can launch on the basis of successful challenges.
• Whether settlements impose “no launch until” dates.
• Whether NDC-level differences allow earlier entry for some strengths.

Without Orange Book patent-by-NDC mapping and Paragraph IV outcomes, a credible launch-risk matrix cannot be constructed.

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Key Takeaways

• AVYCAZ demand is hospital- and stewardship-driven, with volume shaped by antibiogram shifts and formulary contracting.
• Competitive substitution from other β-lactam/β-lactamase inhibitor antibiotics can drive unit volatility even under stable national resistance.
• The generic risk profile is determined by Orange Book blocking patents and any Paragraph IV litigation outcomes; without the Orange Book and case records, exclusivity and launch timing cannot be mapped.
• Financial trajectory planning should focus on contracting wins/losses, net price maintenance, and therapy mix rather than list price.

FAQs

1. What are the main payer and hospital contracting factors that move AVYCAZ net sales quarter to quarter?
2. How do local antibiograms and resistance enzyme patterns change the competitive mix between AVYCAZ and relebactam-based antibiotics?
3. Which AVYCAZ strengths and NDC-level product configurations tend to matter most for generic launch barriers?
4. What types of formulation and manufacturing patents commonly block generic substitution for combination IV antibiotics like AVYCAZ?
5. How do stewardship restrictions and prior authorization rules typically influence conversion from empiric to targeted AVYCAZ prescribing?

References

1. No sources were provided in the prompt, and no Orange Book, litigation, or financial filing data was included.