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Last Updated: February 28, 2025

AVYCAZ Drug Patent Profile


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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

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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
Drug patent expirations by year for AVYCAZ
Drug Prices for AVYCAZ

See drug prices for AVYCAZ

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AVYCAZ
Generic Entry Date for AVYCAZ*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
National Institute of Allergy and Infectious Diseases (NIAID)Phase 1
Michigan State UniversityPhase 1
University of Southern CaliforniaPhase 4

See all AVYCAZ clinical trials

Pharmacology for AVYCAZ
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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of AVYCAZ is ⤷  Try for Free.

This potential generic entry date is based on patent 8,969,566.

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

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Abbvie AVYCAZ avibactam sodium; ceftazidime POWDER;INTRAVENOUS 206494-001 Feb 25, 2015 RX Yes Yes 7,112,592 ⤷  Try for Free Y Y ⤷  Try for Free
Abbvie AVYCAZ avibactam sodium; ceftazidime POWDER;INTRAVENOUS 206494-001 Feb 25, 2015 RX Yes Yes 8,471,025 ⤷  Try for Free Y ⤷  Try for Free
Abbvie AVYCAZ avibactam sodium; ceftazidime POWDER;INTRAVENOUS 206494-001 Feb 25, 2015 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 3 of 3 entries

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

Patent: 6972
Patent: PROCESOS PARA PREPARAR COMPUESTOS HETEROCICLICOS, QUE INCLUYEN TRANS-7-OXO-6-(SULFOOXI)-1,6-DIAZABICICLO[3,2,1]OCTANO-2-CARBOXAMIDA Y SALES DE LA MISMA
Estimated Expiration: ⤷  Try for Free

Australia

Patent: 12270051
Patent: Process for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof
Estimated Expiration: ⤷  Try for Free

Brazil

Patent: 2013032415
Estimated Expiration: ⤷  Try for Free

Canada

Patent: 80403
Patent: PROCEDES DE PREPARATION DE COMPOSES HETEROCYCLIQUES, Y COMPRIS LE TRANS-7-OXO-6-(SULFOXY)-1,6-DIAZABICYCLO¬3,2,1|OCTANE-2-CARBOXAMIDE ET SES SELS (PROCESSES FOR PREPARING HETEROCYCLIC COMPOUNDS INCLUDING TRANS-7-OXO-6-(SULPHOOXY)-1,6-DIAZABICYCLO[3,2,1]OCTANE-2-CARBOXAMIDE AND SALTS THEREOF)
Estimated Expiration: ⤷  Try for Free

China

Patent: 3649051
Patent: Process for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1, 6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof
Estimated Expiration: ⤷  Try for Free

Patent: 5294690
Patent: PROCESSES FOR PREPARING HETEROCYCLIC COMPOUNDS INCLUDING TRANS-7-OXO-6-(SULPHOOXY)-1,6-DIAZABICYCLO[3,2,1]OCTANE-2-CARBOXAMIDE AND SALTS THEREOF
Estimated Expiration: ⤷  Try for Free

European Patent Office

Patent: 21005
Patent: PROCÉDÉ DE PRÉPARATION DE COMPOSÉS HÉTÉROCYCLIQUES, NOTAMMENT LE TRANS-7-OXO-6-(SULPHOOXY)-1,6-DIAZABICYCLO[3,2,1]OCTANE-2-CARBOXAMIDE ET SES SELS (PROCESS FOR PREPARING HETEROCYCLIC COMPOUNDS INCLUDING TRANS-7-OXO-6-(SULPHOOXY)-1,6-DIAZABICYCLO[3,2,1]OCTANE-2-CARBOXAMIDE AND SALTS THEREOF)
Estimated Expiration: ⤷  Try for Free

Hong Kong

Patent: 96615
Patent: 製備包括反式- -氧- 磺酰氧基 -二氮二環 辛烷- -氨甲酰及其鹽的雜環化合物的方法 (PROCESS FOR PREPARING HETEROCYCLIC COMPOUNDS INCLUDING TRANS-7-OXO-6- (SULPHOOXY)-1,6-DIAZABICYCLO[3,2,1]OCTANE-2-CARBOXAMIDE AND SALTS THEREOF -7--6-()-16-[321]-2-)
Estimated Expiration: ⤷  Try for Free

Israel

Patent: 9815
Patent: תהליך להכנת הטרוציקליות הכוללות טרנס- 7 - אוקסו - 6 - (סולפואוקסי) - 1, 6 - דיאזאביציקלו [1,2,3] אוקטאן - 2 - קרבוקסאמיד ומלחים שלהן (Process for preparing heterocyclic compounds including trans-7-oxo- 6 -(sulphooxy)-1, 6 - diazabicyclo [3,2,1] octane- 2-carboxamide and salts thereof)
Estimated Expiration: ⤷  Try for Free

Japan

Patent: 23800
Estimated Expiration: ⤷  Try for Free

Patent: 42462
Estimated Expiration: ⤷  Try for Free

Patent: 14517027
Estimated Expiration: ⤷  Try for Free

Patent: 17036307
Patent: trans−7−オキソ−6−(スルホオキシ)−1,6−ジアザビシクロ[3,2,1]オクタン−2−カルボキサミドとその塩が含まれる複素環式化合物を製造するための方法 (PROCESSES FOR PREPARING HETEROCYCLIC COMPOUNDS INCLUDING TRANS-7-OXO-6-(SULFOOXY)-1,6-DIAZABICYCLO[3,2,1]OCTANE-2-CARBOXAMIDE AND SALTS THEREOF)
Estimated Expiration: ⤷  Try for Free

Malaysia

Patent: 5730
Patent: PROCESS FOR PREPARING HETEROCYCLIC COMPOUNDS INCLUDING TRANS-7-OXO-6-(SULPHOOXY)-1,6-DIAZABICYCLO[3,2,1]OCTANE-2-CARBOXAMIDE AND SALTS THEREOF
Estimated Expiration: ⤷  Try for Free

Mexico

Patent: 1020
Patent: PROCESOS PARA PREPARAR COMPUESTOS HETEROCICLICOS, INCLUIDA TRANS-7-OXO-6-(SULFOOXI)-1,6-DIAZABICICLO [3,2,1]OCTANO-2-CARBOXAM IDA Y SALES DE LA MISMA. (PROCESS FOR PREPARING HETEROCYCLIC COMPOUNDS INCLUDING TRANS-7-OXO-6-(SULPHOOXY)-1,6-DIAZABICYCLO[3,2,1]OCTANE-2-CARBO XAMIDE AND SALTS THEREOF.)
Estimated Expiration: ⤷  Try for Free

Patent: 13014114
Patent: PROCESOS PARA PREPARAR COMPUESTOS HETEROCICLICOS, INCLUIDA TRANS-7-OXO-6-(SULFOOXI)-1,6-DIABAZABICICLO [3,2,1]OCTANO-2-CARBOX AMIDA Y SALES DE LA MISMA. (PROCESS FOR PREPARING HETEROCYCLIC COMPOUNDS INCLUDING TRANS-7-OXO-6-(SULPHOOXY)-1,6-DIAZABICYCLO[3,2,1]OCTANE-2-CARBO XAMIDE AND SALTS THEREOF.)
Estimated Expiration: ⤷  Try for Free

Russian Federation

Patent: 10091
Estimated Expiration: ⤷  Try for Free

Patent: 69076
Patent: СПОСОБ ПОЛУЧЕНИЯ ГЕТЕРОЦИКЛИЧЕСКИХ СОЕДИНЕНИЙ, ВКЛЮЧАЯ ТРАНС-7-ОКСО-6-(СУЛЬФОКСИ)-1,6-ДИАЗАБИЦИКЛО[3.2.1]ОКТАН-2-КАРБОКСАМИД И ЕГО СОЛИ (METHOD OF PRODUCING HETEROCYCLIC COMPOUNDS, INCLUDING TRANS-7-OXO-6-(SULPHOXY)-1,6-DIAZABICYCLO[3.2.1]OCTANE-2-CARBOXAMIDE AND ITS SALT)
Estimated Expiration: ⤷  Try for Free

Patent: 14101244
Patent: СПОСОБ ПОЛУЧЕНИЯ ГЕТЕРОЦИКЛИЧЕСКИХ СОЕДИНЕНИЙ, ВКЛЮЧАЯ ТРАНС-7-ОКСО-6-(СУЛЬФООКСИ)-1, 6-ДИАЗАБИЦИКЛО[3,2,1]ОКТАН-2-КАРБОКСАМИД И ЕГО СОЛИ
Estimated Expiration: ⤷  Try for Free

Patent: 17102358
Patent: СПОСОБ ПОЛУЧЕНИЯ ГЕТЕРОЦИКЛИЧЕСКИХ СОЕДИНЕНИЙ, ВКЛЮЧАЯ ТРАНС-7-ОКСО-6-(СУЛЬФООКСИ)-1,6-ДИАЗАБИцикло[3,2,1]ОКТАН-2-КАРБОКСАМИД И ЕГО СОЛИ
Estimated Expiration: ⤷  Try for Free

Singapore

Patent: 5289
Patent: PROCESS FOR PREPARING HETEROCYCLIC COMPOUNDS INCLUDING TRANS-7-OXO-6-(SULPHOOXY)-1,6-DIAZABICYCLO[3,2,1]OCTANE-2-CARBOXAMIDE AND SALTS THEREOF
Estimated Expiration: ⤷  Try for Free

South Korea

Patent: 2143660
Estimated Expiration: ⤷  Try for Free

Patent: 140040748
Patent: PROCESS FOR PREPARING HETEROCYCLIC COMPOUNDS INCLUDING TRANS-7-OXO-6-(SULPHOOXY)-1,6-DIAZABICYCLO[3,2,1]OCTANE-2-CARBOXAMIDE AND SALTS THEREOF
Estimated Expiration: ⤷  Try for Free

Spain

Patent: 60404
Estimated Expiration: ⤷  Try for Free

Taiwan

Patent: 65706
Estimated Expiration: ⤷  Try for Free

Patent: 1317238
Patent: Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1-,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof
Estimated Expiration: ⤷  Try for Free

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.

CountryPatent NumberTitleEstimated Expiration
Mexico PA03000881 NUEVOS COMPUESTOS HETEROCICLICOS, SU PREPARACION Y SU UTILIZACION COMO MEDICAMENTOS, EN ESPECIAL COMO ANTIBACTERIANOS. (AZABICYCLIC COMPOUNDS, PREPARATION THEREOF AND USE AS MEDICINES, IN PARTICULAR AS ANTIBACTERIAL AGENTS.) ⤷  Try for Free
Portugal 2279737 ⤷  Try for Free
Tunisia SN04137 NOUVEAUX COMPOSES HETEROCYCLIQUES, ACTIFS COMME INHIBITEURS DE BETA-LACTAMASES ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 3 of 3 entries

Supplementary Protection Certificates for AVYCAZ

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
1480644 122016000105 Germany ⤷  Try for Free PRODUCT NAME: CEFTAZIDIM ODER EIN SALZ DAVON MIT AVIBACTAM ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/16/1109 20160624
1480644 132016000125850 Italy ⤷  Try for Free 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 C01480644/01 Switzerland ⤷  Try for Free PRODUCT NAME: AVIBACTAM + CEFTAZIDIM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66890 05.06.2019
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 3 of 3 entries

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]

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.