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Last Updated: August 3, 2020

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AZTREONAM - Generic Drug Details

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What are the generic sources for aztreonam and what is the scope of freedom to operate?

Aztreonam is the generic ingredient in four branded drugs marketed by Gilead, Bristol Myers Squibb, Fresenius Kabi Usa, and West-ward Pharms Int, and is included in five NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aztreonam has fifty-six patent family members in twenty-one countries.

There are eight drug master file entries for aztreonam. Three suppliers are listed for this compound.

Drug Prices for AZTREONAM

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Recent Clinical Trials for AZTREONAM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institute of Allergy and Infectious Diseases (NIAID)Phase 1
University of WashingtonPhase 2/Phase 3
Hospital Universitari Joan XXIII de Tarragona.Phase 2/Phase 3

See all AZTREONAM clinical trials

Pharmacology for AZTREONAM
Medical Subject Heading (MeSH) Categories for AZTREONAM

US Patents and Regulatory Information for AZTREONAM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
West-ward Pharms Int AZTREONAM aztreonam INJECTABLE;INJECTION 065286-001 Mar 23, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb AZACTAM IN PLASTIC CONTAINER aztreonam INJECTABLE;INJECTION 050632-002 May 24, 1989 DISCN Yes No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb AZACTAM IN PLASTIC CONTAINER aztreonam INJECTABLE;INJECTION 050632-001 May 24, 1989 DISCN Yes No   Start Trial   Start Trial   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 AZTREONAM

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2158901 C 2018 012 Romania   Start Trial PRODUCT NAME: AZTREONAM LIZINA; NATIONAL AUTHORISATION NUMBER: EU/1/09/543/001; DATE OF NATIONAL AUTHORISATION: 20090921; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/09/543/001; DATE OF FIRST AUTHORISATION IN EEA: 20090921
2158901 122018000042 Germany   Start Trial PRODUCT NAME: AZTREONAMLYSIN; REGISTRATION NO/DATE: EU/1/09/543/001 20090921
1353647 2011/024 Ireland   Start Trial PRODUCT NAME: AZTREONAM LYSINE; REGISTRATION NO/DATE: EU/1/09/543/001 20090923
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Boehringer Ingelheim
Medtronic
Baxter
McKesson
Harvard Business School

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