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1. (2s,5r)-2-carbamoyl-3-methyl-7-oxo-1,6-diazabicyclo(3.2.1)oct-3-en-6-yl Sulfate
2. Etx2514
3. Sulfuric Acid, Mono((2s,5r)-2-(aminocarbonyl)-3-methyl-7-oxo-1,6-diazabicyclo(3.2.1)oct-3-en-6-yl) Ester
1. Durlobactam [inn]
2. Durlobactam [usan]
3. Psa33ko9wa
4. 1467829-71-5
5. Ext2514
6. [(2s,5r)-2-carbamoyl-3-methyl-7-oxo-1,6-diazabicyclo[3.2.1]oct-3-en-6-yl] Hydrogen Sulfate
7. Sulfuric Acid, Mono((2s,5r)-2-(aminocarbonyl)-3-methyl-7-oxo-1,6-diazabicyclo(3.2.1)oct-3-en-6-yl) Ester
8. Unii-psa33ko9wa
9. Durlobactam (usan/inn)
10. Durlobactam [usan:inn]
11. Chembl4298137
12. Schembl15319894
13. Who 10824
14. Zinc220881117
15. D11591
16. (2s,5r)-2-carbamoyl-3-methyl-7-oxo-1,6-diazabicyclo(3.2.1)oct-3-en-6-yl Sulfate
17. (2s,5r)-2-carbamoyl-3-methyl-7-oxo-1,6-diazabicyclo[3.2.1]oct-3-en-6-yl Hydrogen Sulfate
| Molecular Weight | 277.26 g/mol |
|---|---|
| Molecular Formula | C8H11N3O6S |
| XLogP3 | -2 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 3 |
| Exact Mass | 277.03685625 g/mol |
| Monoisotopic Mass | 277.03685625 g/mol |
| Topological Polar Surface Area | 139 Ų |
| Heavy Atom Count | 18 |
| Formal Charge | 0 |
| Complexity | 536 |
| 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 |
beta-Lactamase Inhibitors
Endogenous substances and drugs that inhibit or block the activity of BETA-LACTAMASES. (See all compounds classified as beta-Lactamase Inhibitors.)
API SUPPLIERS
NDC Package Code : 61121-0005
Start Marketing Date : 2023-06-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
NDC API
NDC Package Code : 61121-0005
Start Marketing Date : 2023-06-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Details:
The collaboration aims for the commercialisation of novel antibacterial drug Xacduro (sulbactam-durlobactam) for the treatment of carbapenem-resistant Acinetobacter baumannii, in mainland China.
Lead Product(s): Sulbactam,Durlobactam
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xacduro
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Pfizer Inc
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration November 21, 2024
Lead Product(s) : Sulbactam,Durlobactam
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : Undisclosed
Deal Type : Collaboration
Zai Lab and Pfizer Collaborate on XACDURO® for Novel Antibacterial Applications
Details : The collaboration aims for the commercialisation of novel antibacterial drug Xacduro (sulbactam-durlobactam) for the treatment of carbapenem-resistant Acinetobacter baumannii, in mainland China.
Product Name : Xacduro
Product Type : Antibiotic
Upfront Cash : Undisclosed
November 21, 2024
Details:
Xacduro (sulbactam & durlobactam), co-packaged for intravenous use, which act as beta-lactamase inhibitor, approved in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.
Lead Product(s): Sulbactam,Durlobactam
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xacduro
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 18, 2023
Lead Product(s) : Sulbactam,Durlobactam
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
XACDURO®, The First and Only Antibiotic Developed to Target Acinetobacter, Now Available to Treat...
Details : Xacduro (sulbactam & durlobactam), co-packaged for intravenous use, which act as beta-lactamase inhibitor, approved in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneum...
Product Name : Xacduro
Product Type : Antibiotic
Upfront Cash : Inapplicable
September 18, 2023
Details:
Xacduro (sulbactam for injection; durlobactam for injection), combination of sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor, approved for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.
Lead Product(s): Sulbactam,Durlobactam
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xacduro
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 23, 2023
Lead Product(s) : Sulbactam,Durlobactam
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Innoviva Specialty Therapeutics Announces FDA Approval for XACDURO® (sulbactam for injection; dur...
Details : Xacduro (sulbactam for injection; durlobactam for injection), combination of sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor, approved for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneum...
Product Name : Xacduro
Product Type : Antibiotic
Upfront Cash : Inapplicable
May 23, 2023
Details:
ETX2514 is a combination of sulbactam, an IV β-lactam antibiotic, and durlobactam, a rationally designed broad-spectrum IV β-lactamase inhibitor, being developed for the treatment of infections due to Acinetobacter aumanniicalcoaceticus complex.
Lead Product(s): Sulbactam,Durlobactam
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xacduro
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 17, 2023
Lead Product(s) : Sulbactam,Durlobactam
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Sulbactam-Durlobactam Unanimously Recommended for Approval by FDA Advisory Committee
Details : ETX2514 is a combination of sulbactam, an IV β-lactam antibiotic, and durlobactam, a rationally designed broad-spectrum IV β-lactamase inhibitor, being developed for the treatment of infections due to Acinetobacter aumanniicalcoaceticus complex.
Product Name : Xacduro
Product Type : Antibiotic
Upfront Cash : Inapplicable
April 17, 2023
Details:
ETX2514 or SUL-DUR is a combination of sulbactam, an IV β-lactam antibiotic, and durlobactam, a rationally designed broad-spectrum IV β-lactamase inhibitor, being developed for the treatment of infections due to Acinetobacter aumanniicalcoaceticus complex.
Lead Product(s): Sulbactam,Durlobactam
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xacduro
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: Innoviva
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 13, 2023
Lead Product(s) : Sulbactam,Durlobactam
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Innoviva
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ETX2514 or SUL-DUR is a combination of sulbactam, an IV β-lactam antibiotic, and durlobactam, a rationally designed broad-spectrum IV β-lactamase inhibitor, being developed for the treatment of infections due to Acinetobacter aumanniicalcoaceticus com...
Product Name : Xacduro
Product Type : Antibiotic
Upfront Cash : Inapplicable
March 13, 2023
Details:
Sulbactam (SUL-DUR) is a β-lactam antibiotic with activity against Acinetobacter baumannii; however, β-lactamase-mediated resistance to sulbactam is now widespread rendering it generally ineffective.
Lead Product(s): Sulbactam,Durlobactam
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xacduro
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 10, 2022
Lead Product(s) : Sulbactam,Durlobactam
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Sulbactam (SUL-DUR) is a β-lactam antibiotic with activity against Acinetobacter baumannii; however, β-lactamase-mediated resistance to sulbactam is now widespread rendering it generally ineffective.
Product Name : Xacduro
Product Type : Antibiotic
Upfront Cash : Inapplicable
December 10, 2022
Details:
SUL-DUR is an IV, investigational drug that is a combination of sulbactam, an IV β-lactam antibiotic, and durlobactam, a rationally designed broad-spectrum IV BLI, being developed for the treatment of infections caused by ABC, including carbapenem-resistant strains.
Lead Product(s): Sulbactam,Durlobactam,Imipenem
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xacduro
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 30, 2022
Lead Product(s) : Sulbactam,Durlobactam,Imipenem
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : SUL-DUR is an IV, investigational drug that is a combination of sulbactam, an IV β-lactam antibiotic, and durlobactam, a rationally designed broad-spectrum IV BLI, being developed for the treatment of infections caused by ABC, including carbapenem-resis...
Product Name : Xacduro
Product Type : Antibiotic
Upfront Cash : Inapplicable
November 30, 2022
Details:
Entasis brings to Innoviva an exciting portfolio that includes potentially first- and best-in-class medicines for the treatment of multidrug-resistant Gram-negative bacteria, including lead asset SUL-DUR.
Lead Product(s): Sulbactam,Durlobactam
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xacduro
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: Innoviva
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition November 07, 2022
Lead Product(s) : Sulbactam,Durlobactam
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Innoviva
Deal Size : Undisclosed
Deal Type : Acquisition
Innoviva Completes Acquisition of Entasis Therapeutics
Details : Entasis brings to Innoviva an exciting portfolio that includes potentially first- and best-in-class medicines for the treatment of multidrug-resistant Gram-negative bacteria, including lead asset SUL-DUR.
Product Name : Xacduro
Product Type : Antibiotic
Upfront Cash : Undisclosed
November 07, 2022
Details:
Sulbactam-Durlobactam (SUL-DUR) is an IV, investigational drug that is combination of sulbactam, an IV β-lactam antibiotic, and durlobactam, novel broad-spectrum IV BLI, developed for treatment of infections caused by ABC complex, including carbapenem-resistant strains.
Lead Product(s): Sulbactam,Durlobactam,Imipenem
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xacduro
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 19, 2022
Lead Product(s) : Sulbactam,Durlobactam,Imipenem
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Sulbactam-Durlobactam (SUL-DUR) is an IV, investigational drug that is combination of sulbactam, an IV β-lactam antibiotic, and durlobactam, novel broad-spectrum IV BLI, developed for treatment of infections caused by ABC complex, including carbapenem-r...
Product Name : Xacduro
Product Type : Antibiotic
Upfront Cash : Inapplicable
October 19, 2022
Details:
The primary efficacy endpoint, 28-day all-cause mortality (ACM) in carbapenem resistant Acinetobacter baumannii-calcoaceticus (CRABC) m-MITT cohort (n=125) was 19.0% (12/63) and 32.3% (20/62) for SUL-DUR versus colistin, respectively (difference -13.2% [95% CI: -30.0, 3.5]).
Lead Product(s): Sulbactam,Durlobactam
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xacduro
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 26, 2022
Lead Product(s) : Sulbactam,Durlobactam
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The primary efficacy endpoint, 28-day all-cause mortality (ACM) in carbapenem resistant Acinetobacter baumannii-calcoaceticus (CRABC) m-MITT cohort (n=125) was 19.0% (12/63) and 32.3% (20/62) for SUL-DUR versus colistin, respectively (difference -13.2% [...
Product Name : Xacduro
Product Type : Antibiotic
Upfront Cash : Inapplicable
April 26, 2022
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
NEWS #PharmaBuzz
ABOUT THIS PAGE
48
PharmaCompass offers a list of Durlobactam 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 Durlobactam manufacturer or Durlobactam supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Durlobactam manufacturer or Durlobactam supplier.
PharmaCompass also assists you with knowing the Durlobactam API Price utilized in the formulation of products. Durlobactam API Price is not always fixed or binding as the Durlobactam Price is obtained through a variety of data sources. The Durlobactam Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Durlobactam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Durlobactam, including repackagers and relabelers. The FDA regulates Durlobactam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Durlobactam API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Durlobactam supplier is an individual or a company that provides Durlobactam active pharmaceutical ingredient (API) or Durlobactam finished formulations upon request. The Durlobactam suppliers may include Durlobactam API manufacturers, exporters, distributors and traders.
click here to find a list of Durlobactam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Durlobactam as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Durlobactam API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Durlobactam as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Durlobactam and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Durlobactam NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Durlobactam suppliers with NDC on PharmaCompass.
Durlobactam 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 Durlobactam 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 Durlobactam GMP manufacturer or Durlobactam GMP API supplier for your needs.
A Durlobactam CoA (Certificate of Analysis) is a formal document that attests to Durlobactam's compliance with Durlobactam specifications and serves as a tool for batch-level quality control.
Durlobactam CoA mostly includes findings from lab analyses of a specific batch. For each Durlobactam 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.
Durlobactam may be tested according to a variety of international standards, such as European Pharmacopoeia (Durlobactam EP), Durlobactam JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Durlobactam USP).
