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avycaz Drug Patent Profile

Which patents cover Avycaz, 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:	1
Clinical Trials:	3
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 four FDA Regulatory Exclusivities.

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
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

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
Spain	2560404
Croatia	P20040686	NOVI HETEROCIKLIÄŚKI SPOJEVI KOJI DJELUJU KAO INHIBITORI BETA-LAKTAMAZA (NOVEL HETEROCYCLIC COMPOUNDS WHICH ARE ACTIVE AS INHIBITORS OF BETA-LACTAMASES)
Ecuador	SP034460	NUEVOS COMPUESTOS HETEROCICLICOS, SU PREPARACION Y SU UTILIZACION COMO MEDICAMENTOS, EN ESPECIAL COMO ANTIBACTERIANOS
World Intellectual Property Organization (WIPO)	2012172368

Supplementary Protection Certificates for avycaz

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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,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	93338	Luxembourg		PRODUCT NAME: MELANGE OU ASSOCIATION PHARMACEUTIQUE COMPRENANT COMME INGREDIENTS ACTIFS : (1) CEFTAZIDIME OU UN SEL DE CELUI-CI ET (2) AVIBACTAM OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/16/1109 - ZAVICEFTA - CEFTAZIDIME/AVIBACTAM
1480644	629	Finland

Avycaz Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Avycaz

Introduction

Avycaz, a combination antibiotic consisting of ceftazidime and avibactam, is a significant player in the antimicrobial drugs market. Understanding its market dynamics and financial trajectory is crucial for assessing its performance and potential in the pharmaceutical industry.

Market Context

Avycaz operates within the antimicrobial (AM) drug cohort, which faces unique challenges. The market for new antimicrobial drugs has seen slow uptake in recent years, partly due to the dominance of generic, off-patent antibiotics that are often effective and low-priced[3].

Sales Performance

Quarterly Sales

Avycaz has shown notable sales performance within its cohort. In its 24th quarter on the market, which was Q1 2021, Avycaz achieved the highest quarterly sales among AM drugs, reaching $99.54 million. This is significantly higher than most other AM drugs, which typically reach between $5 and $10 million in quarterly sales after 1–2 years and up to $10 to $40 million after about 5 years on the market[1].

Cumulative Sales

The cumulative sales data for Avycaz indicate steady growth. While the first 16 quarters show consistent growth, sales tend to stabilize and fluctuate between $36 and $42 million per quarter after the 17th quarter. This pattern suggests that Avycaz has reached a stable market position but has not yet achieved peak-year sales, which may occur several years after approval[1].

Comparative Market Performance

Against Non-AM Comparator Cohort

Avycaz's sales, although impressive within the AM cohort, are lower compared to drugs in the non-AM comparator cohort. For example, Bridion, a drug in the non-AM comparator cohort, achieved $311.77 million in sales in its 51st quarter, far surpassing Avycaz's highest quarterly sales[1].

Against Oncology Cohort

The sales of Avycaz are significantly lower than those of drugs in the oncology cohort. Drugs like Ibrance in the oncology cohort have achieved quarterly sales of up to $1,515.75 million, highlighting the vast difference in market performance between these cohorts[1].

Financial Metrics

Annual Revenue

Avycaz generated $126.7 million in annual revenue in 2022, placing it among the top-selling antibiotics in the U.S. However, this figure is modest compared to other high-performing drugs in different cohorts[3].

Development and Approval Costs

Despite its relatively lower sales, Avycaz benefits from lower development and approval costs compared to drugs in other cohorts. The average capitalized development and approval costs for AM cohort drugs, including Avycaz, are approximately $1,508 million, which is lower than the costs for non-AM comparator and oncology cohort drugs[4].

Market Challenges

Generic Competition

One of the primary challenges facing Avycaz is the dominance of generic antibiotics in the market. Generic antibiotics account for the majority of antibiotic sales, both in the U.S. and globally, due to their effectiveness and lower prices[3].

Slow Market Uptake

New antimicrobial drugs, including Avycaz, have experienced slow market uptake. This is partly due to the availability of effective generic alternatives and the high development costs associated with bringing new antibiotics to market[1].

Impact of External Factors

COVID-19 Pandemic

The COVID-19 pandemic has had a significant impact on the pharmaceutical industry, including the sales trajectories of antimicrobial drugs. However, the specific impact on Avycaz's sales was not detailed in the available data, but it is likely that the pandemic affected its market performance to some extent[1].

Expert Insights and Statistics

• Average Annual Revenue: The average global annual revenue for new antibiotic drugs launched between 2010 and 2020 was estimated to be around $46 million, highlighting the modest economic performance of novel antibiotics[3].
• Top-Selling Antibiotics: Avycaz ranks among the top-selling antibiotics in the U.S., but its sales are dwarfed by those of generic antibiotics and drugs in other therapeutic areas[3].

"Generic antibiotics are top-selling products... Global statistics also suggest generic antibiotics now account for the majority of antibiotic volume." - Source: Harvard University Report[3]

Key Takeaways

• Sales Performance: Avycaz has achieved significant sales within the AM cohort but lags behind drugs in other cohorts.
• Market Challenges: The dominance of generic antibiotics and slow market uptake are major challenges.
• Financial Metrics: Avycaz benefits from lower development and approval costs but generates modest annual revenue.
• External Factors: The COVID-19 pandemic may have affected its sales trajectory.

FAQs

What are the highest quarterly sales achieved by Avycaz?

Avycaz achieved its highest quarterly sales of $99.54 million in its 24th quarter on the market, which was Q1 2021[1].

How does Avycaz compare to drugs in the non-AM comparator cohort?

Avycaz's sales are lower compared to drugs in the non-AM comparator cohort, such as Bridion, which achieved $311.77 million in sales in its 51st quarter[1].

What are the average development and approval costs for AM cohort drugs?

The average capitalized development and approval costs for AM cohort drugs, including Avycaz, are approximately $1,508 million[4].

Why do new antimicrobial drugs, including Avycaz, experience slow market uptake?

New antimicrobial drugs face slow market uptake due to the availability of effective generic alternatives and the high development costs associated with bringing new antibiotics to market[1].

How does the COVID-19 pandemic affect the sales of Avycaz?

While the specific impact on Avycaz's sales is not detailed, the COVID-19 pandemic likely affected its market performance, as it did with many other drugs[1].

Sources

1. NCBI: MARKET PERFORMANCE ANALYSIS - Antimicrobial Drugs[1]
2. Allergan: Allergan Reports Fourth Quarter and Full-Year 2019 Financial Results[2]
3. Harvard University: Sizing A Market Entry Reward for the Development of New Antibiotics[3]
4. ASPE: antimicrobial drugs market returns analysis final[4]