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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

See drug prices for aztreonam

Recent Clinical Trials for aztreonam

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

Sponsor	Phase
Pfizer	Phase 1
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1
University of Washington	Phase 2/Phase 3

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

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
Gilead	CAYSTON	aztreonam	FOR SOLUTION;INHALATION	050814-001	Feb 22, 2010		RX	Yes	Yes			Y
Gilead	CAYSTON	aztreonam	FOR SOLUTION;INHALATION	050814-001	Feb 22, 2010		RX	Yes	Yes			Y
Bristol Myers Squibb	AZACTAM IN PLASTIC CONTAINER	aztreonam	INJECTABLE;INJECTION	050632-002	May 24, 1989		DISCN	Yes	No
Fresenius Kabi Usa	AZTREONAM	aztreonam	INJECTABLE;INJECTION	065439-001	Jun 18, 2010		RX	No	No
Bristol Myers Squibb	AZACTAM	aztreonam	INJECTABLE;INJECTION	050580-002	Dec 31, 1986	AP	RX	Yes	Yes
Bristol Myers Squibb	AZACTAM	aztreonam	INJECTABLE;INJECTION	050580-001	Dec 31, 1986		DISCN	No	No

International Patents for aztreonam

Country	Patent Number	Estimated Expiration
Japan	2007527398
Cyprus	1119753
Hungary	S1800012
Luxembourg	91851
Portugal	1641436
Australia	2017200384
Canada	2433280

Supplementary Protection Certificates for aztreonam

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2158901	122018000042	Germany		PRODUCT NAME: AZTREONAMLYSIN; REGISTRATION NO/DATE: EU/1/09/543/001 20090921
1353647	C300492	Netherlands		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
1353647	2011/024	Ireland		PRODUCT NAME: AZTREONAM LYSINE; REGISTRATION NO/DATE: EU/1/09/543/001 20090923
2158901	2018C/001	Belgium		PRODUCT NAME: CAYSTON - AZTREONAM; AUTHORISATION NUMBER AND DATE: EU/1/09/543/001 20090923
1353647	11C0030	France		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		PRODUCT NAME: AZTREONAMLYSIN; REGISTRATION NO/DATE: SWISSMEDIC 59389 06.12.2010