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Last Updated: January 25, 2020

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AVYCAZ Drug Profile

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US ANDA Litigation and Generic Entry Outlook for Avycaz

Avycaz was eligible for patent challenges on December 31, 1968.

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.

Indicators of Generic Entry

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Summary for AVYCAZ
Drug patent expirations by year for AVYCAZ
Drug Prices for AVYCAZ

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Generic Entry Opportunity 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
Synonyms for AVYCAZ
1393723-27-7
Avibactam / Ceftazidime
Avibactam and Ceftazidime
Avibactam mixture with Ceftazidime
Ceftazidime-avibactam mixture
Zavicefta

US Patents and Regulatory Information for AVYCAZ

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;IV (INFUSION) 206494-001 Feb 25, 2015 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Allergan AVYCAZ avibactam sodium; ceftazidime POWDER;IV (INFUSION) 206494-001 Feb 25, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan AVYCAZ avibactam sodium; ceftazidime POWDER;IV (INFUSION) 206494-001 Feb 25, 2015 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Allergan AVYCAZ avibactam sodium; ceftazidime POWDER;IV (INFUSION) 206494-001 Feb 25, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan AVYCAZ avibactam sodium; ceftazidime POWDER;IV (INFUSION) 206494-001 Feb 25, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan AVYCAZ avibactam sodium; ceftazidime POWDER;IV (INFUSION) 206494-001 Feb 25, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for AVYCAZ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1480644 16C1019 France   Start Trial 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 2016/056 Ireland   Start Trial PRODUCT NAME: A COMBINATION OF CEFTAZIDIME OR A SALT THEREOF, AND AVIBACTAM OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/16/1109/001 20160624
1480644 300847 Netherlands   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
1480644 2016C/069 Belgium   Start Trial PRODUCT NAME: ZAVICEFTA (COMBINAISON DE CEFTAZIDIME ET AVIBACTAM); AUTHORISATION NUMBER AND DATE: EU/1/16/1109/001 20160628
1307457 C 2016 055 Romania   Start Trial PRODUCT NAME: AVIBACTAM SAU O SARE A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1109; DATE OF NATIONAL AUTHORISATION: 20160624; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1109; DATE OF FIRST AUTHORISATION IN EEA: 20160624
1480644 PA2016037 Lithuania   Start Trial PRODUCT NAME: CEFTAZIDIMAS + AVIBAKTAMAS; REGISTRATION NO/DATE: EU/1/16/1109/001 20160624
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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