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Last Updated: October 5, 2024

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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 Allergan 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 ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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

Patents protecting AVYCAZ

Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD OF TREATING BACTERIAL INFECTIONS IN COMPLICATED INTRA-ABDOMINAL INFECTION AND COMPLICATED URINARY TRACT INFECTION, INCLUDING PYELONEPHRITIS, PATIENTS COMPRISING ADMINISTERING A BACTERICIDALLY EFFECTIVE AMOUNT OF AVIBACTAM SODIUM

Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD OF TREATING BACTERIAL INFECTIONS IN HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (HABP/VABP) PATIENTS COMPRISING ADMINISTERING A BACTERICIDALLY EFFECTIVE AMOUNT OF AVIBACTAM SODIUM

Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING BACTERIAL INFECTIONS

Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS, COMPLICATED URINARY TRACT INFECTIONS, AND HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA IN ADULT AND PEDIATRIC PATIENTS (AT LEAST 31 WEEKS GESTATIONAL AGE)

Heterocyclic compounds as inhibitors of beta-lactamases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

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

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

FDA Regulatory Exclusivity protecting AVYCAZ

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Sign Up

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Sign Up

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan AVYCAZ avibactam sodium; ceftazidime POWDER;INTRAVENOUS 206494-001 Feb 25, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Allergan AVYCAZ avibactam sodium; ceftazidime POWDER;INTRAVENOUS 206494-001 Feb 25, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Allergan AVYCAZ avibactam sodium; ceftazidime POWDER;INTRAVENOUS 206494-001 Feb 25, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Allergan AVYCAZ avibactam sodium; ceftazidime POWDER;INTRAVENOUS 206494-001 Feb 25, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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: ⤷  Sign Up

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: ⤷  Sign Up

Brazil

Patent: 2013032415
Estimated Expiration: ⤷  Sign Up

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: ⤷  Sign Up

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: ⤷  Sign Up

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: ⤷  Sign Up

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: ⤷  Sign Up

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: ⤷  Sign Up

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: ⤷  Sign Up

Japan

Patent: 23800
Estimated Expiration: ⤷  Sign Up

Patent: 42462
Estimated Expiration: ⤷  Sign Up

Patent: 14517027
Estimated Expiration: ⤷  Sign Up

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: ⤷  Sign Up

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: ⤷  Sign Up

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: ⤷  Sign Up

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: ⤷  Sign Up

Russian Federation

Patent: 10091
Estimated Expiration: ⤷  Sign Up

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: ⤷  Sign Up

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: ⤷  Sign Up

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: ⤷  Sign Up

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: ⤷  Sign Up

South Korea

Patent: 2143660
Estimated Expiration: ⤷  Sign Up

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: ⤷  Sign Up

Spain

Patent: 60404
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 65706
Estimated Expiration: ⤷  Sign Up

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: ⤷  Sign Up

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
Portugal 1307457 ⤷  Sign Up
Hungary 226889 NEW HETEROCYCLIC COMPOUNDS, PREPARATION THEREOF AND USE AS MEDICINES, IN PARTICULAR AS ANTIBACTERIAL AGENTS ⤷  Sign Up
Lithuania C1480644 ⤷  Sign Up
Germany 60102702 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AVYCAZ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1480644 SPC/GB17/004 United Kingdom ⤷  Sign Up PRODUCT NAME: COMBINATION OF CEFTAZIDIME, OR A SALT THEREOF, AND AVIBACTAM, OR A SALT THEREOF; REGISTERED: UK EU/1/16/1109/001 20160628
1480644 629 Finland ⤷  Sign Up
1480644 2016C/069 Belgium ⤷  Sign Up PRODUCT NAME: ZAVICEFTA (COMBINAISON DE CEFTAZIDIME ET AVIBACTAM); AUTHORISATION NUMBER AND DATE: EU/1/16/1109/001 20160628
1480644 132016000125850 Italy ⤷  Sign Up 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.