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Generated: April 20, 2018

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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.
Pharmacology for aztreonam
Ingredient-typeMonobactams
Drug ClassMonobactam Antibacterial
Medical Subject Heading (MeSH) Categories for aztreonam
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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bristol Myers Squibb AZACTAM aztreonam INJECTABLE;INJECTION 050580-002 Dec 31, 1986 AP RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa AZTREONAM aztreonam INJECTABLE;INJECTION 065439-003 Jun 18, 2010 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead CAYSTON aztreonam FOR SOLUTION;INHALATION 050814-001 Feb 22, 2010 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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

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Supplementary Protection Certificates for aztreonam

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0030 France ➤ Sign Up 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 ➤ Sign Up 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 ➤ Sign Up
11/024 Ireland ➤ Sign Up PRODUCT NAME: AZTREONAM LYSINE; REGISTRATION NO/DATE: EU/1/09/543/001 20090923
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Julphar
QuintilesIMS
Boehringer Ingelheim
Medtronic
Colorcon
Federal Trade Commission
Covington
US Department of Justice

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