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.

Summary for aztreonam

US Patents:	0
Tradenames:	4
Applicants:	5
NDAs:	6
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	57
Patent Applications:	7,170
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

See drug prices for aztreonam

Recent Clinical Trials for aztreonam

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

Sponsor	Phase
Allergan	Phase 3
University of Dundee	Phase 2
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1

See all aztreonam clinical trials

Pharmacology for aztreonam

Drug Class	Monobactam Antibacterial

Medical Subject Heading (MeSH) Categories for aztreonam

Anti-Bacterial Agents

US Patents and Regulatory Information for aztreonam

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Glossary

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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

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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

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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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