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Last Updated: December 4, 2022

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, Hikma, and Hospira, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for aztreonam

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Recent Clinical Trials for aztreonam

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SponsorPhase
AllerganPhase 3
University of DundeePhase 2
National Institute of Allergy and Infectious Diseases (NIAID)Phase 1

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
Hikma AZTREONAM aztreonam INJECTABLE;INJECTION 065286-001 Mar 23, 2011 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hospira AZTREONAM aztreonam INJECTABLE;INJECTION 206517-001 Nov 8, 2021 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Fresenius Kabi Usa AZTREONAM aztreonam INJECTABLE;INJECTION 065439-002 Jun 18, 2010 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb AZACTAM IN PLASTIC CONTAINER aztreonam INJECTABLE;INJECTION 050632-002 May 24, 1989 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb AZACTAM aztreonam INJECTABLE;INJECTION 050580-002 Dec 31, 1986 AP RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for aztreonam

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead CAYSTON aztreonam FOR SOLUTION;INHALATION 050814-001 Feb 22, 2010 See Plans and Pricing See Plans and Pricing
Gilead CAYSTON aztreonam FOR SOLUTION;INHALATION 050814-001 Feb 22, 2010 See Plans and Pricing See Plans and Pricing
Gilead CAYSTON aztreonam FOR SOLUTION;INHALATION 050814-001 Feb 22, 2010 See Plans and Pricing See Plans and Pricing
Gilead CAYSTON aztreonam FOR SOLUTION;INHALATION 050814-001 Feb 22, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for aztreonam

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Gilead Sciences Ireland UC Cayston aztreonam EMEA/H/C/000996
Cayston is indicated for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older.Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Authorised no no no 2009-09-21
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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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.