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Last Updated: March 6, 2021

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Aztreonam - Generic Drug Details

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What are the generic drug 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.

Summary for aztreonam
International Patents:56
US Patents:4
Tradenames:4
Applicants:4
NDAs:5
Drug Master File Entries: 8
Suppliers / Packagers: 3
Bulk Api Vendors: 81
Clinical Trials: 52
Patent Applications: 7,534
Formulation / Manufacturing:see details
Drug Prices: Drug price trends for aztreonam
What excipients (inactive ingredients) are in aztreonam?aztreonam excipients list
DailyMed Link:aztreonam at DailyMed
Drug Prices for aztreonam

See drug prices for aztreonam

Recent Clinical Trials for aztreonam

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

SponsorPhase
PfizerPhase 1
National Institute of Allergy and Infectious Diseases (NIAID)Phase 1
University of WashingtonPhase 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
Gilead CAYSTON aztreonam FOR SOLUTION;INHALATION 050814-001 Feb 22, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead CAYSTON aztreonam FOR SOLUTION;INHALATION 050814-001 Feb 22, 2010 RX Yes Yes   Start Trial   Start Trial Y   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
Fresenius Kabi Usa AZTREONAM aztreonam INJECTABLE;INJECTION 065439-001 Jun 18, 2010 RX No No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb AZACTAM aztreonam INJECTABLE;INJECTION 050580-002 Dec 31, 1986 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb AZACTAM aztreonam INJECTABLE;INJECTION 050580-001 Dec 31, 1986 DISCN No 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 122018000042 Germany   Start Trial PRODUCT NAME: AZTREONAMLYSIN; REGISTRATION NO/DATE: EU/1/09/543/001 20090921
1353647 C300492 Netherlands   Start Trial PRODUCT NAME: AZTREONAM, NIET IN EEN SAMENSTELLING MET ARGININE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN AZTREONAM, ANDERS DAN EEN ARGININEZOUT, IN HET BIJZONDER ALS AZTREONAMLYSINE; REGISTRATION NO/DATE: EU/1/09/543/001 20090921
1353647 365 Finland   Start Trial
1353647 2011/024 Ireland   Start Trial PRODUCT NAME: AZTREONAM LYSINE; REGISTRATION NO/DATE: EU/1/09/543/001 20090923
2158901 2018C/001 Belgium   Start Trial PRODUCT NAME: CAYSTON - AZTREONAM; AUTHORISATION NUMBER AND DATE: EU/1/09/543/001 20090923
1353647 11C0030 France   Start Trial PRODUCT NAME: AZTREONAM LYSINE; REGISTRATION NO/DATE IN FRANCE: EU/1/09/543/001 DU 20090921; REGISTRATION NO/DATE AT EEC: EU/1/09/543/001 DU 20090921
1353647 C01353647/01 Switzerland   Start Trial PRODUCT NAME: AZTREONAMLYSIN; REGISTRATION NO/DATE: SWISSMEDIC 59389 06.12.2010
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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