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Last Updated: October 20, 2019

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AVYCAZ Drug Profile

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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

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

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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 Sales Llc AVYCAZ avibactam sodium; ceftazidime POWDER;IV (INFUSION) 206494-001 Feb 25, 2015 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Allergan Sales Llc AVYCAZ avibactam sodium; ceftazidime POWDER;IV (INFUSION) 206494-001 Feb 25, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan Sales Llc AVYCAZ avibactam sodium; ceftazidime POWDER;IV (INFUSION) 206494-001 Feb 25, 2015 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Allergan Sales Llc AVYCAZ avibactam sodium; ceftazidime POWDER;IV (INFUSION) 206494-001 Feb 25, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan Sales Llc 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
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 93338 Luxembourg   Start Trial 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 PA2016037,C1480644 Lithuania   Start Trial 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 300847 Netherlands   Start Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
1480644 C20160041 00213 Estonia   Start Trial PRODUCT NAME: TSEFTASIDIIM/AVIBAKTAAM;REG NO/DATE: EU/1/16/1109 28.06.2016
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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