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Last Updated: March 4, 2021

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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 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.

Indicators of Generic Entry

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Summary for AVYCAZ
International Patents:193
US Patents:8
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 1
Clinical Trials: 3
Formulation / Manufacturing:see details
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

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

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   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   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
>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 122016000105 Germany   Start Trial PRODUCT NAME: CEFTAZIDIM ODER EIN SALZ DAVON MIT AVIBACTAM ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/16/1109 20160624
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
1480644 58/2016 Austria   Start Trial PRODUCT NAME: KOMBINATION AUS CEFTAZIDIM UND AVIBACTAM; REGISTRATION NO/DATE: EU/1/16/1109 (MITTEILUNG) 20160628
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 132016000125850 Italy   Start Trial 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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Serving leading biopharmaceutical companies globally:

Baxter
Merck
Boehringer Ingelheim
Moodys
AstraZeneca
McKesson

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