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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 aztreonam patent protection?

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 forty-nine patent family members in eighteen countries.

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

Summary for aztreonam

International Patents:	49
US Patents:	4
Tradenames:	4
Applicants:	4
NDAs:	5
Drug Master File Entries:	8
Suppliers / Packagers:	3
Bulk Api Vendors:	48
Clinical Trials:	44
Patent Applications:	7,576
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
DailyMed Link:	aztreonam at DailyMed

Pharmacology for aztreonam

Ingredient-type	Monobactams
Drug Class	Monobactam Antibacterial

Medical Subject Heading (MeSH) Categories for aztreonam

Anti-Bacterial Agents

Synonyms for aztreonam

(2S,3S)-3-((Z)-2-(2-ammoniothiazol-4-yl)-2-(((2-carboxypropan-2-yl)oxy)imino)acetamido)-2-methyl-4-oxoazetidine-1-sulfonate

(2S,3S)-3-({(2Z)-2-(2-ammonio-1,3-thiazol-4-yl)-2-[(1-carboxy-1-methylethoxy)imino]ethanoyl}amino)-2-methyl-4-oxoazetidine-1-sulfonate

(2S,3S)-3-({(2Z)-2-(2-ammonio-1,3-thiazol-4-yl)-2-[(1-carboxy-1-methylethoxy)imino]ethanoyl}amino)-2-methyl-4-oxoazetidine-1-sulfonate(aztreonam)

(2S,3S)-3-[(2Z)-2-(2-azaniumyl-1,3-thiazol-4-yl)-2-[(1-carboxy-1-methylethoxy)imino]acetamido]-2-methyl-4-oxoazetidine-1-sulfonate

(2S,3S)-3-[[(2Z)-2-(2-ammonio-4-thiazolyl)-2-(2-carboxypropan-2-yloxyimino)-1-oxoethyl]amino]-2-methyl-4-oxo-1-azetidinesulfonate

(2S,3S)-3-[[(2Z)-2-(2-azaniumyl-1,3-thiazol-4-yl)-2-(2-methyl-1-oxidanyl-1-oxidanylidene-propan-2-yl)oxyimino-ethanoyl]amino]-2-methyl-4-oxidanylidene-azetidine-1-sulfonate

(Z)-2-((((2-Amino-4-thiazolyl)(((2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl)carbamoyl)methylene)amino)oxy)-2-methylpropionic acid

(Z)-2-[[[(2-Amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3- azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid

[2S-[2alpha,3beta(Z)]]-2-[[[1-(2-Amino-4-thiazolyl)-2-[(2-methyl-4-oxo-1-sulfo-3-azetidinyl)amino]-2-oxoethylidene]amino]oxy]-2-methylpropanoic acid

110A380

2-((((E)-1-(2-aminothiazol-4-yl)-2-(((2S,3S)-2-methyl-4-oxo-1-sulfoazetidin-3-yl)amino)-2-oxoethylidene)amino)oxy)-2-methylpropanoic acid

2-((((Z)-1-(2-aminothiazol-4-yl)-2-(((2S,3S)-2-methyl-4-oxo-1-sulfoazetidin-3-yl)amino)-2-oxoethylidene)amino)oxy)-2-methylpropanoic acid

2-(((Z)-(1-(2-Aminothiazol-4-yl)-2-(((2S,3S)-2-methyl-4-oxo-1-sulfoazetidin-3-yl)amino)-2-oxoethylidene)amino)oxy)-2-methylpropanoic acid

2-({[(1Z)-1-(2-amino-1,3-thiazol-4-yl) -2- {[(2S,3S)-2-methyl-4-oxo-1-sulfoazetidin-3-yl]amino} -2- oxoethylidene]amino}oxy)-2-methylpropanoic acid

2-({[(1Z)-1-(2-amino-1,3-thiazol-4-yl)-2-{[(2S,3S)-2-methyl-4-oxo-1-sulfoazetidin-3-yl]amino}-2-oxoethylidene]amino}oxy)-2-methylpropanoic acid

2-[(Z)-[1-(2-amino-1,3-thiazol-4-yl)-2-[[(2S,3S)-2-methyl-4-oxo-1-sulfoazetidin-3-yl]amino]-2-oxoethylidene]amino]oxy-2-methylpropanoic acid

2-[(Z)-[1-(2-aminothiazol-4-yl)-2-[[(2S,3S)-2-methyl-4-oxo-1-sulfo-azetidin-3-yl]amino]-2-oxo-ethylidene]amino]oxy-2-methyl-propanoic acid

2-[[(Z)-[1-(2-Amino-4-thiazolyl)-2-[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]amino]-2-oxoethylidene]amino]oxy]-2-methylpropionic Acid

2-[1-(2-Amino-thiazol-4-yl)-1-((2S,3S)-2-methyl-4-oxo-1-sulfo-azetidin-3-ylcarbamoyl)-meth-(Z)-ylideneaminooxy]-2-methyl-propionic acid

78110-38-0

A839338

AB2000129

AC-4330

AC1NX3U2

AK-41883

AKOS015840157

AKOS015961777

AKOS026750006

Ambap78110-38-0

AN-12074

Antibiotic squibb 26,776

AS-13760

Az-threonam

Azactam

Azactam (TN)

AZACTAM IN PLASTIC CONTAINER

Azetreonam

Azonam

Azthreonam

Aztreon

Aztreonam (Azactam, Cayston)

Aztreonam (JP17/USP/INN)

Aztreonam [USAN:INN:BAN:JAN]

Aztreonam [USAN:USP:INN:BAN:JAN]

Aztreonam lysine

Aztreonam, analytical standard

Aztreonam, pharmaceutical secondary standard; traceable to USP

Aztreonam, United States Pharmacopeia (USP) Reference Standard

Aztreonamum

Aztreonamum [Latin]

BC208259

BCP9000372

BCPP000356

BDBM50240480

BIDD:GT0765

BPBio1_000121

BRD-K62607865-001-03-0

BRN 3577211

BSPBio_000109

C06840

C13H17N5O8S2

Cayston

CC-24234

CCG-220185

CHEBI:161680

CHEMBL158

Corus 1020

CS-1902

D00240

D0F2XV

DB00355

Dynabiotic

E-Aztreonam

EINECS 278-839-9

G2B4VE5GH8

HMS1568F11

HMS2090K09

HMS2095F11

HY-B0129

J10266

LS-121219

MFCD00072145

MLS003915628

MLS006011974

MolPort-003-886-345

Monobactam

Monobactam, SQ 26776, Squibb 26776, Aztreonam

Monobactam;SQ 26776;Squibb 26776;Azactam;Cayston

NCGC00179656-01

Nebactam

NSC 646279

NSC-646279

NSC646279

Prestwick_914

Prestwick2_000185

Prestwick3_000185

Primbactam

Propanoic acid, 2-(((1-(2-amino-4-thiazolyl)-2-((2-methyl-4-oxo-1-sulfo-3-azetidinyl)amino)-2-oxoethylidene)amino)oxy)-2-methyl-, (2S-(2-alpha,3-beta(Z)))-

Propanoic acid, 2-(((1-(2-amino-4-thiazolyl)-2-((2-methyl-4-oxo-1-sulfo-3-azetidinyl)amino)-2-oxoethylidene)amino)oxy)-2-methyl-, (2S-(2alpha,3beta(Z)))-

Propanoic acid, 2-[[(Z)-[1-(2-amino-4-thiazolyl)-2-[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]amino]-2-oxoethylidene]amino]oxy]-2-methyl-

PubChem13620

RP18114

S1505

SCHEMBL37511

SMR002204030

SMR004703537

SO-26776

SQ 26,776

SQ 26776

SQ-26,776

SQ-26776

Squibb 26,776

Squibb 26776

SR-01000841814

SR-01000841814-2

UNII-G2B4VE5GH8

Urobactam

WZPBZJONDBGPKJ-VEHQQRBSSA-N

ZINC12503091

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
Fresenius Kabi Usa	AZTREONAM	aztreonam	INJECTABLE;INJECTION	065439-002	Jun 18, 2010	AP	RX	No	No
Bristol Myers Squibb	AZACTAM	aztreonam	INJECTABLE;INJECTION	050580-002	Dec 31, 1986	AP	RX	Yes	Yes
Fresenius Kabi Usa	AZTREONAM	aztreonam	INJECTABLE;INJECTION	065439-003	Jun 18, 2010	AP	RX	No	No
Gilead	CAYSTON	aztreonam	FOR SOLUTION;INHALATION	050814-001	Feb 22, 2010		RX	Yes	Yes			Y

Non-Orange Book US Patents for aztreonam

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,841,286	Inhalable aztreonam lysinate formulation for treatment and prevention of pulmonary bacterial infections
9,345,663	Inhalable aztreonam lysinate formulation for treatment and prevention of pulmonary bacterial infections
9,533,000	Inhalable aztreonam for treatment and prevention of pulmonary bacterial infections
6,660,249	Inhalable dry powder aztreonam for treatment and prevention of pulmonary bacterial infections

International Patents for aztreonam

Country	Document Number	Estimated Expiration
Australia	2012202089
Luxembourg	91851
Norway	2011001
Japan	4646489

Supplementary Protection Certificates for aztreonam

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0030	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
00492	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
2011 00021	Denmark
11/024	Ireland		PRODUCT NAME: AZTREONAM LYSINE; REGISTRATION NO/DATE: EU/1/09/543/001 20090923