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Last Updated: November 25, 2020

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AVYCAZ Drug Profile

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US ANDA Litigation and Generic Entry Outlook for Avycaz

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

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
>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
1480644 PA2016037 Lithuania   Start Trial PRODUCT NAME: CEFTAZIDIMAS + AVIBAKTAMAS; REGISTRATION NO/DATE: EU/1/16/1109/001 20160624
1480644 C01480644/01 Switzerland   Start Trial PRODUCT NAME: AVIBACTAM + CEFTAZIDIM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66890 05.06.2019
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Moodys
McKinsey
Boehringer Ingelheim
AstraZeneca
Medtronic
Colorcon

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.