Synopsis
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1. Nxl 104
2. Nxl-104
3. Nxl104
1. 1192500-31-4
2. Avibactam Free Acid
3. Nxl104
4. Ave-1330a Free Acid
5. Avibactam (free Acid)
6. Nxl-104 Free Acid
7. Chembl1689063
8. Chebi:85984
9. 06mfo7817i
10. [(2s,5r)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl] Hydrogen Sulfate
11. 396731-14-9
12. (2s,5r)-7-oxo-6-(sulfooxy)-1,6-diazabicyclo[3.2.1]octane-2-carboxamide
13. 1,6-diazabicyclo(3.2.1)octane-2-carboxamide, 7-oxo-6-(sulfooxy)-, (1r,2s,5r)-rel-
14. (1r,2s,5r)-2-carbamoyl-7-oxo-1,6-diazabicyclo[3.2.1]octan-6-yl Hydrogen Sulfate
15. Avibactam [inn]
16. Avibactam [usan:inn]
17. Unii-06mfo7817i
18. Avibactamfreeacid
19. Sulfuric Acid, Mono((1r,2s,5r)-2-(aminocarbonyl)-7-oxo-1,6-diazabicyclo(3.2.1)oct-6-yl) Ester
20. Sulfuric Acid, Mono[(1r,2s,5r)-2-(aminocarbonyl)-7-oxo-1,6-diazabicyclo[3.2.1]oct-6-yl] Ester
21. Unii-7352665165
22. Avibactam [mi]
23. Avibactam [usan]
24. Avibactam [who-dd]
25. Schembl1666807
26. Avibactam, (+/-)-
27. Gtpl10761
28. Dtxsid901026066
29. Amy24028
30. Avi
31. Zavicefta Component Avibactam
32. Zinc9302239
33. Bdbm50339145
34. Avibactam Component Of Zavicefta
35. Cs-0593
36. Db09060
37. Ac-35749
38. Hy-14879
39. E80372
40. Q15410251
41. Trans-7-oxo-6-(sulfooxy)-1,6-diazabicyclo[3.2.1]octan-2-carboxamide
42. (1r,2s,5r)-7-oxo-6-sulfooxy-1,6-diazabicyclo(3.2.1)octane-2-carboxamide
43. 794508-22-8
Molecular Weight | 265.25 g/mol |
---|---|
Molecular Formula | C7H11N3O6S |
XLogP3 | -1.8 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 6 |
Rotatable Bond Count | 3 |
Exact Mass | 265.03685625 g/mol |
Monoisotopic Mass | 265.03685625 g/mol |
Topological Polar Surface Area | 139 Ų |
Heavy Atom Count | 17 |
Formal Charge | 0 |
Complexity | 457 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 2 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
AVYCAZ (ceftazidime-avibactam), in combination with metronidazole, is indicated for the treatment of complicated intra-abdominal infections caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Providencia stuartii, Enterobacter cloacae, Klebsiella oxytoca, and Pseudomonas aeruginosa in patients 18 years or older. AVYCAZ is also indicated for the treatment of complicated urinary tract infections including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Citrobacter freundii, Proteus spp., and Pseudomonas aeruginosa in patients 18 years or older.
FDA Label
beta-Lactamase Inhibitors
Endogenous substances and drugs that inhibit or block the activity of BETA-LACTAMASES. (See all compounds classified as beta-Lactamase Inhibitors.)
Route of Elimination
Avibactam and ceftazidime are excreted mainly by the kidneys.
Volume of Distribution
The steady state volumes of distribution of avibactam and ceftazidime is 22.2L and 17L respectively.
Clearance
Avibactam and ceftazidime has a clearance of ~12L/h and ~7L/h respectively.
No metabolism of avibactam was observed in human liver preparations. Unchanged avibactam is the major drug-related component in human plasma and urine. 80-90% of ceftazidime is eliminated as unchanged .
Ceftazidime-avibactam has a half life of ~2.7-3.0 hours.
Avibactam is a non- lactam -lactamase inhibitor that inactivates some -lactamases (Ambler class A -lactamases, including Klebsiella pneumoniae carbapenemases, Ambler class C and some Ambler class D -lactamases) by a unique covalent and reversible mechanism, and protects ceftazidime from degradation by certain -lactamases. Avibactam rapidly reaches the periplasm of bacteria at high enough concentrations to restore activity of ceftazidime against ceftazidime-resistant, -lactamase-producing strains. Avibactam does not decrease the activity of ceftazidime against ceftazidime susceptible organisms.
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Details:
Emblaveo (aztreonam-avibactam), a beta-lactamase inhibitor, has been FDA approved for the treatment of adult patients with complicated intra-abdominal infections in patients 18 years and older.
Lead Product(s): Aztreonam,Avibactam,Metronidazole
Therapeutic Area: Infections and Infectious Diseases Brand Name: Emblaveo
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Pfizer Inc
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 07, 2025
Lead Product(s) : Aztreonam,Avibactam,Metronidazole
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
U.S. FDA Approves EMBLAVEO™ for Complicated Intra-Abdominal Infections
Details : Emblaveo (aztreonam-avibactam), a beta-lactamase inhibitor, has been FDA approved for the treatment of adult patients with complicated intra-abdominal infections in patients 18 years and older.
Product Name : Emblaveo
Product Type : Antibiotic
Upfront Cash : Inapplicable
February 07, 2025
Details:
Undisclosed
Lead Product(s): Ceftibuten,Avibactam,CTB-AVP
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 19, 2024
Lead Product(s) : Ceftibuten,Avibactam,CTB-AVP
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 19, 2024
Details:
Undisclosed
Lead Product(s): Aztreonam,Avibactam
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Antibiotic
Sponsor: AbbVie Inc
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 17, 2024
Lead Product(s) : Aztreonam,Avibactam
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : AbbVie Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
June 17, 2024
Details:
Emblaveo (aztreonam-avibactam), a beta-lactamase inhibitor, is FDA approved for treating adult patients with complicated intra-abdominal infections, HAP, and cUTIs, including pyelonephritis.
Lead Product(s): Aztreonam,Avibactam,Metronidazole
Therapeutic Area: Infections and Infectious Diseases Brand Name: Emblaveo
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 22, 2024
Lead Product(s) : Aztreonam,Avibactam,Metronidazole
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
European Commission Approves Pfizer’s EMBLAVEO® for Resistant Infections
Details : Emblaveo (aztreonam-avibactam), a beta-lactamase inhibitor, is FDA approved for treating adult patients with complicated intra-abdominal infections, HAP, and cUTIs, including pyelonephritis.
Product Name : Emblaveo
Product Type : Antibiotic
Upfront Cash : Inapplicable
April 22, 2024
Details:
Zidavi, which is a novel combination of ceftazidime and avibactam, a preferred treatment against OXA-48-like and Klebsiella pneumoniae carbapenemase-producing carbapenem-resistant Enterobacteriaceae for pyelonephritis or Complicated Urinary Tract Infections.
Lead Product(s): Ceftazidime,Avibactam
Therapeutic Area: Infections and Infectious Diseases Brand Name: Zidavi
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 31, 2023
Lead Product(s) : Ceftazidime,Avibactam
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Zidavi, which is a novel combination of ceftazidime and avibactam, a preferred treatment against OXA-48-like and Klebsiella pneumoniae carbapenemase-producing carbapenem-resistant Enterobacteriaceae for pyelonephritis or Complicated Urinary Tract Infecti...
Product Name : Zidavi
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 31, 2023
Details:
ATM-AVI (aztreonam-avibactam) is an investigational treatment for infections caused by Gram-negative bacteria with limited treatment options. It combines aztreonam, a monobactam β-lactam, with avibactam, a recent broad-spectrum β-lactamase inhibitor.
Lead Product(s): Aztreonam,Avibactam,Metronidazole
Therapeutic Area: Infections and Infectious Diseases Brand Name: Emblaveo
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 06, 2023
Lead Product(s) : Aztreonam,Avibactam,Metronidazole
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Phase 3 Studies of Pfizer’s Novel Antibiotic Combination Offer New Treatment Hope for Patients w...
Details : ATM-AVI (aztreonam-avibactam) is an investigational treatment for infections caused by Gram-negative bacteria with limited treatment options. It combines aztreonam, a monobactam β-lactam, with avibactam, a recent broad-spectrum β-lactamase inhibitor.
Product Name : Emblaveo
Product Type : Antibiotic
Upfront Cash : Inapplicable
January 06, 2023
Details:
Undisclosed
Lead Product(s): YK-1169,Cefepime Hydrochloride,Avibactam
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 20, 2022
Lead Product(s) : YK-1169,Cefepime Hydrochloride,Avibactam
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Study on Tolerance, Pharmacokinetics and Drug Interaction of YK-1169 in Healthy Volunteers
Details : Undisclosed
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
October 20, 2022
Details:
Undisclosed
Lead Product(s): Aztreonam,Avibactam
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 22, 2021
Lead Product(s) : Aztreonam,Avibactam
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
July 22, 2021
Details:
Undisclosed
Lead Product(s): Aztreonam,Avibactam
Therapeutic Area: Nephrology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 24, 2020
Lead Product(s) : Aztreonam,Avibactam
Therapeutic Area : Nephrology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Pharmacokinetic Study of Aztreonam-Avibactam in Severe Renal Impairment
Details : Undisclosed
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
July 24, 2020
Details:
Undisclosed
Lead Product(s): Ceftazidime,Avibactam
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Allergan
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 14, 2019
Lead Product(s) : Ceftazidime,Avibactam
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Allergan
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 14, 2019
Regulatory Info :
Registration Country : Switzerland
Brand Name : Zavicefta
Dosage Form : Dry Sub
Dosage Strength : 2g/0.5g
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Zavicefta
Dosage Form : POI
Dosage Strength : 0.5g
Packaging : 20X10g
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : India
Brand Name : Avithem
Dosage Form : Injection
Dosage Strength : 2GM; 0.5GM
Packaging : 20
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name : Acejet
Dosage Form : Injection
Dosage Strength : 2GM; 0.5GM
Packaging : 20
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name : Avinef
Dosage Form : Injection
Dosage Strength : 2GM; 0.5GM
Packaging : 20
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Global Sales Information
Market Place
ABOUT THIS PAGE
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PharmaCompass offers a list of Avibactam API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Avibactam manufacturer or Avibactam supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Avibactam manufacturer or Avibactam supplier.
PharmaCompass also assists you with knowing the Avibactam API Price utilized in the formulation of products. Avibactam API Price is not always fixed or binding as the Avibactam Price is obtained through a variety of data sources. The Avibactam Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Avibactam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Avibactam, including repackagers and relabelers. The FDA regulates Avibactam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Avibactam API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Avibactam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Avibactam supplier is an individual or a company that provides Avibactam active pharmaceutical ingredient (API) or Avibactam finished formulations upon request. The Avibactam suppliers may include Avibactam API manufacturers, exporters, distributors and traders.
click here to find a list of Avibactam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
Avibactam Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Avibactam GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Avibactam GMP manufacturer or Avibactam GMP API supplier for your needs.
A Avibactam CoA (Certificate of Analysis) is a formal document that attests to Avibactam's compliance with Avibactam specifications and serves as a tool for batch-level quality control.
Avibactam CoA mostly includes findings from lab analyses of a specific batch. For each Avibactam CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Avibactam may be tested according to a variety of international standards, such as European Pharmacopoeia (Avibactam EP), Avibactam JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Avibactam USP).